Melody™ Transcatheter Pulmonary Valve
Ensemble™ Transcatheter Valve Delivery System
Ensemble™ II Transcatheter Valve Delivery System
Instructions for Use
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
Trademarks may be registered and are the property of their respective owners.
Sterile LC: Device has been sterilized using Liquid Chemical
Sterilants according to EN/ISO 14160.
Explanation of symbols on package labeling
Model
Use By
Consult Instructions for Use at this Website
Do Not Reuse
Size
Serial Number
Catalog Number
Temperature Limit
Quantity
Lot Number
Sterilized Using Ethylene Oxide
Open Here
Nonpyrogenic
MR Conditional
Maximum Guidewire Compatibility
Rated Burst Pressure
Do Not Exceed Rated Burst Pressure
Do Not Resterilize
Manufacturer
Do Not Use if Indicator Turns Black
Do Not Use if Package is Damaged
Keep Away from Sunlight
For US Audiences Only
1
PB1016
18 mm to 20 mm
20 mm
PB1018
18 mm to 22 mm
22 mm
NU1018
ENS1018
18 mm
NU1020
ENS1020
20 mm
NU1022
ENS1022
22 mm
1.0 Device description
The implant system consists of the Melody™ transcatheter pulmonary valve, model PB10 (stented
bovine jugular vein valve) and either the Ensemble™ transcatheter valve delivery system, model NU10
or the Ensemble™ II transcatheter valve delivery system, model ENS10.
1.1 Melody™ transcatheter pulmonary valve (TPV)
The TPV consists of a heterologous (bovine) jugular vein valve sutured within a laser-welded, platinumiridium stent with gold brazing of the welds. The TPV is available in a 16 mm bovine jugular vein
(nominal length of 30 mm) and an 18 mm bovine jugular vein (nominal length of 28 mm). A final
sterilization step is performed using a sterilant that contains 1% glutaraldehyde and 20% isopropyl
alcohol, and in which the TPV is preserved and packaged until used. Adequate rinsing with isotonic
saline solution must be performed before implantation to reduce the glutaraldehyde concentration.
See Table 1 for TPV sizing recommendations.
Table 1: TPV sizing
TPV catalog number Diameter of intended
implant location
Maximum expanded inner
diameter of the TPV
1.2 Ensemble™ and Ensemble™ II transcatheter valve delivery system (delivery system)
Each delivery system consists of a balloon-in-balloon catheter with a retractable polytetrafluoroethylene
(PTFE) sheath large enough to cover the TPV after crimping. The delivery system has a 22 Fr crossing
profile. At inflation, the inner balloon is half the diameter of the outer balloon. Both balloons are made
of nylon. The delivery system’s sheath has a side-port used to flush the system and a hemostatic sleeve
over the sheath to minimize bleeding at the insertion site. The delivery system has a polyether block
amide (Pebax®, Arkema Corporation) distal obturator that is conical in shape. The delivery system is
compatible with a 0.889 mm (0.035 in) guidewire. The Ensemble™ II delivery system also includes
radiopaque marker bands on the delivery system beneath the balloons. The marker bands are intended to
aid in visibility of balloon location under fluoroscopy.
See Table 2 for delivery system sizes.
Table 2: Delivery system sizes
Ensemble™
delivery system
catalog number
Ensemble™ II delivery
system catalog
number
2
Outer balloon outer
diameter
2.0 Indications for use
The Melody™ TPV is indicated for use in the management of pediatric and adult patients who have a
clinical indication for intervention on a dysfunctional right ventricular outflow tract (RVOT) conduit or
surgical bioprosthetic pulmonary valve that has ≥ moderate regurgitation, and/or a mean RVOT gradient
≥35 mm Hg.
3
3.0 Contraindications
None known.
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4.0 Warnings and precautions
4.1 Warnings
Do not implant in the aortic or mitral position. Preclinical bench testing of the TPV suggests that
valve function and durability will be extremely limited when used in these locations.
Do not use if patient’s anatomy precludes introduction of the valve, if the venous anatomy cannot
accommodate a 22 Fr size introducer, or if there is significant obstruction of the central veins.
Do not use if there are clinical or biological signs of infection including active endocarditis. Standard
medical and surgical care should be strongly considered in these circumstances.
4.1.1 Procedural
The potential for compression of a coronary artery should be considered in all patients undergoing TPV
implantation. Assessment of the coronary artery anatomy for the risk of compression should be
performed in all patients prior to deployment of the TPV. Aortography should be performed to define
the anatomy of the coronary arteries and their relationship to the implant location. If aortography
demonstrates a coronary artery branch passing beneath or otherwise close to the implant location, or if
coronary anatomy could not be determined, further evaluation with selective coronary arteriography and
simultaneous inflation of an angioplasty balloon across the implant location obstruction should be
performed. If inflation of the balloon demonstrates any suggestion of coronary compression, as
demonstrated by simultaneous selective coronary arteriography, the patient should be deemed
anatomically unsuitable for TPV implantation.
The risk of conduit rupture should be considered in all patients undergoing TPV implantation in a
conduit. To minimize the risk of conduit rupture, do not use a balloon with a diameter greater than 110%
of the nominal diameter (original implant size) of the conduit for predilation of the intended deployment
site or for deployment of the TPV. Also, reports in literature suggest that having covered stents available
during preparation of the implant site can be of use in containing ruptured or dissected right ventricular
outflow tract conduit injury should it occur during preparation for TPV implant.
4.1.2 TPV
The RVOT is a dynamic structure, and stents placed in the RVOT may be exposed to complex cyclic
stresses related to the cardiac cycle. The risk factors for stent fracture after TPV implant have not been
fully defined. However, prominent mechanical stresses on the outflow tract stent, such as compression
between the anterior chest wall and heart, appear to be associated with an increased risk of stent fracture.
Other factors are likely to contribute to the risk of stent fracture as well.
The potential for stent fracture should be considered in all patients who undergo TPV placement,
regardless of the previously discussed or subsequently characterized risk factors. Radiographic
assessment of the stent with chest radiography or fluoroscopy should be included in the routine
postprocedural evaluation of patients who receive a TPV. In particular, in patients found to have a
substantial increase in the degree of RVOT obstruction, the possibility of an associated stent fracture
should be considered and evaluated. If a stent fracture is detected, continue monitoring the valve
performance in conjunction with clinically appropriate hemodynamic assessment. In patients with stent
fracture and significant associated RVOT obstruction or regurgitation, reintervention should be
considered in accordance with usual clinical practice (Section 6.2).
This device was designed for single patient use only. Do not reuse, reprocess, or resterilize this product.
Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or
create a risk of contamination of the device, which could result in patient injury, illness, or death.
5
Do not resterilize the TPV by any method. Exposure of the device and container to irradiation, steam,
ethylene oxide, or other chemical sterilants will render the device unfit for use.
Do not use the device if:
• The device has been dropped, damaged, or mishandled in any way
• The Use By date has elapsed
• Each tamper-evident seal is broken
• The serial number tag on the TPV does not match the serial number on the container label
• The shipping temperature indicator window inside the shelf carton is black. If the shipping
temperature indicator is black, the TPV is not suitable for clinical use.
• The storage solution does not completely cover the device or there is evidence of leakage
Do not expose the device to solutions other than the storage and rinsing solutions.
Do not add antibiotics to either the storage or the rinse solution. Do not apply antibiotics to the device.
Do not allow the device to dry. Maintain tissue moisture with irrigation or immersion.
Do not attempt to repair a damaged device.
Do not handle or use forceps to manipulate the valve leaflet tissue.
Do not use forceps to manipulate the stent.
Do not overexpand the device beyond the maximum recommended size as shown in Table 1, as this
may result in a regurgitant TPV.
4.1.3 Delivery system
This device was designed for single patient use only. Do not reuse, reprocess, or resterilize this product.
Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or
create a risk of contamination of the device, which could result in patient injury, illness, or death.
Do not use air or any gaseous substance as a balloon-inflation medium.
Do not advance the guidewire, balloon-dilatation catheter, or any other component if resistance is met,
without first determining the cause and taking remedial action.
Do not remove the guidewire from the delivery system at any time during the procedure.
4.1.4 Other
Safety and effectiveness of the device has not been demonstrated in pregnant patients.
Because of the inherent risks cited above, institutions planning to implant the TPV should be prepared to
urgently proceed to surgical intervention with cardiopulmonary bypass or with urgent implementation of
extracorporeal membrane oxygenation (ECMO) support.
4.2 Precautions
• Rinsing procedures of the TPV must be strictly followed.
• Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Avoid prolonged
or repeated exposure to or breathing of the chemical vapor. Use only with adequate ventilation. If
skin contact occurs, immediately flush the affected area with water for a minimum of 15 minutes. In
6
the event of eye contact, flush with water for a minimum of 15 minutes and seek medical attention
immediately.
• The sealed delivery system packaging should be inspected prior to opening. If the seal is broken or
the packaging has been damaged, sterility cannot be assured.
• Proper functioning of the delivery system depends on its integrity. Use caution when handling the
delivery system. Damage may result from kinking, stretching, or forceful wiping of the delivery
system.
• This delivery system is not recommended for pressure measurement or delivery of fluids.
• Maintain tight catheter connections and use aspiration before proceeding to avoid air introduction
into the system.
• The delivery system must be carefully flushed to avoid the introduction of air bubbles.
• Before crimping (reducing) the size of the TPV on the balloon, the orientation should be verified.
Note: The blue suture should be adjacent to the blue tip of the delivery system.
• Do not remove the tag attached to the TPV until the TPV is ready to be crimped onto the delivery
system, and implantation is imminent. This tag, along with the blue suture, identifies the outflow end
of the TPV and helps with proper orientation of the TPV on the delivery system.
• The inflation diameter of the balloon used during TPV delivery should approximate the diameter of
the obstructive vessel and the intended implant site.
• The crimping procedure must be carried out carefully. While crimping, the orientation of the valve
must be known at all times. No change of orientation should occur as the TPV is mounted on the
balloon. Do not place excessive pressure on the device during crimping.
• Use of 2 inflation devices (1 for each balloon) with pressure gauges is highly recommended during
this procedure when inflating the balloon to deliver the TPV.
• The TPV is rigid and may make navigation through vessels difficult.
• Balloon deployment should be conducted under fluoroscopic guidance with appropriate X-ray
equipment.
• Ensure the balloons are completely deflated before pulling the delivery system back into the sheath.
• If resistance is felt upon attempted removal of the delivery system, ensure that both balloons have
deflated completely and that there is no rupture of either the inner or outer balloons. This can be
easily detected by the presence of blood in the balloon. If this occurs, maintain guidewire position
and gently withdraw the delivery system using a twisting action under fluoroscopic observation. If
the balloon catheter has seized the guidewire and cannot be withdrawn, then a second venous line
should be inserted, and a catheter directed through the expanded TPV, and a second guidewire
placed in the pulmonary artery. The original delivery system and guidewire can then be carefully
removed together under fluoroscopic guidance.
• The safety and effectiveness of a Melody™ TPV implanted within a failed preexisting transcatheter
bioprosthesis or within another Melody™ TPV have not been demonstrated.
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5.0 Potential adverse events
The following list includes potential procedural complications that may result from implantation of the
TPV:
• Rupture of the RVOT conduit
• Compression of a coronary artery
• Perforation of a major blood vessel
• Embolization or migration of the TPV
• Perforation of a heart chamber
• Arrhythmias
• Allergic reaction to contrast media
• Cerebrovascular events (transient ischemic attack [TIA], cerebrovascular accident [CVA])
• Infection/sepsis
• Fever
• Hematoma
• Radiation-induced erythema, blistering, or peeling of the skin
• Pain, swelling, or bruising at the catheterization site
The following list includes potential device-related adverse events that may occur following TPV
implantation:
• Stent fracture1
• Stent fracture resulting in recurrent obstruction
• Endocarditis
• Embolization or migration of the TPV
• Valvular dysfunction (stenosis or regurgitation)
• Paravalvular leak
• Valvular thrombosis
• Pulmonary thromboembolism
• Hemolysis
1
The term “stent fracture” refers to the fracture of the Melody™ TPV. However, in subjects with multiple stents in the
RVOT it is difficult to definitively attribute stent fractures to the Melody™ frame versus another stent.
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6.0 Patient information
6.1 Anticoagulation/antiplatelet information
Patients may require anticoagulation and/or antiplatelet therapy for an indefinite time period based on
each patient’s condition and physician recommendation.
Alternative antiplatelet/anticoagulation therapy should be considered for patients with known allergies
to aspirin or heparin.
6.2 Identification and management of stent fractures
The potential for stent fracture should be considered in all patients who undergo TPV placement,
regardless of the previously discussed or subsequently characterized risk factors.
6.2.1 Identification
For patients found to have a substantial increase in the degree of RVOT obstruction, the possibility of an
associated stent fracture should be considered and evaluated. Radiographic assessment of the stent with
chest radiography or fluoroscopy should be included in the routine postprocedural evaluation of patients
who receive a TPV.
6.2.2 Management
If a stent fracture is detected, continued monitoring of the stent should be performed in conjunction with
clinically appropriate hemodynamic assessment. In patients with stent fracture and significant associated
RVOT obstruction or regurgitation, reintervention should be considered in accordance with usual
clinical practice.
Reintervention may include implantation of an additional Melody™ TPV or surgical conduit
replacement. Note that limited data are available in the Melody™ clinical studies on reimplantation of
another Melody™ TPV within the original Melody™ TPV (Section 10.0).
6.3 Endocarditis
Endocarditis is a potential adverse event associated with all bioprosthetic valves (Section 5.0). Patients
should make their health care providers aware that they have a bioprosthetic valve before any procedure.
Unexplained, prolonged fever may be an indication of infection, and patients with these conditions
should be advised to seek medical attention.
TPV-related endocarditis has been reported in patients implanted with the Melody™ TPV
(Section 10.0), with cumulative incidence rates in the Melody™ TPV post-approval study data ranging
from 8.7% to 15% at five years. Endocarditis occurred at a higher rate in the new-enrollment postapproval study (PAS) than in the Long term follow up PAS. While the long-term follow up PAS
incidence rate was nearly twice as high among non-pre-stented patients compared to pre-stented patients
(Section 10.1.3.2), the new enrollment PAS incidence had the opposite effect where the rate was twice
as high among pre-stented patients compared to non-pre-stented patients (Section 10.2.3.2). Figure 13
compares the rates of endocarditis over time between the long-term follow up PAS and the new
enrollment PAS (Section 10.3.2.3). The collected post-approval study data suggest the risk of
endocarditis in the Melody™ TPV patient population requires careful consideration.
Prophylactic antibiotic therapy is recommended for patients implanted with a Melody™ TPV
undergoing dental procedures.
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6.4 Registration information
A patient registration form is included in each TPV package. After implantation, please complete all
requested information. The serial number is located on both the package and the identification tag
attached to the TPV. Return the original form to the Medtronic address indicated on the form and
provide the temporary identification card to the patient prior to discharge.
Medtronic will provide an Implanted Device Identification Card to the patient. The card contains the
name and telephone number of the patient’s physician as well as information that medical personnel
would require in the event of an emergency. Patients should be encouraged to carry this card with them
at all times.
6.5 MRI safety information
Nonclinical testing and modeling has demonstrated that the Melody™ TPV is MR Conditional. A
patient with this device can be safely scanned in an MR system meeting the following conditions:
• Static magnetic field of 1.5 T and 3.0 T
• Maximum spatial gradient magnetic field of 2500 gauss/cm (25 T/m)
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2.0 W/kg
for 15 minutes of scanning (Normal Operating Mode)
Based on nonclinical testing and modeling, under the scan conditions defined above, the Melody™ TPV
is expected to produce a maximum in vivo temperature rise of less than 2.1°C after 15 minutes of
continuous scanning.
MR image quality may be compromised if the area of interest is in the same area, or relatively close to
the position of the device. In nonclinical testing, the image artifact caused by the device extends
approximately 3 mm from the Melody™ TPV when imaged with a spin echo pulse sequence and 6 mm
when imaged with a gradient echo pulse sequence and a 3.0 T MRI System. The lumen of the device
was obscured.
For deployment of a Melody™ TPV inside a bioprosthesis, consult the MRI labeling pertaining to the
bioprosthesis for additional image artifact information. It may be necessary to optimize MR imaging
parameters for the presence of this implant.
Scanning under the conditions defined above may be performed immediately after implantation.
The presence of other implants or medical circumstances of the patient may require lower limits on
some or all of the above parameters.
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7.0 How supplied
7.1 Packaging
The TPV is chemically sterilized and provided sterile and nonpyrogenic in a sealed glass container
with a screw cap. Sterility is compromised if each tamper-evident seal is broken, the container is
damaged, or leakage is evident. The outside of the container is nonsterile and should not be placed in
the sterile field.
The delivery system is sterilized with ethylene oxide gas and packaged in a double pouch. The delivery
system is sterile if the pouches are undamaged and unopened. Do not use the delivery system if the outer
pouch is damaged. The delivery system should never be stored in only the inner pouch. The inner pouch
does not provide a sterile barrier. The outer surfaces of the outer pouch are nonsterile and must not be
placed in the sterile field.
7.2 Storage
Store the TPV at 15°C to 25°C (59°F to 77°F). Store the delivery system at room temperature and away
from direct sunlight. The delivery system should never be stored in only the inner pouch. The inner
pouch does not provide a sterile barrier.
Appropriate inventory control should be maintained so that devices with the earliest Use By dates are
preferentially used to avoid expiration. Devices must be used by the Use By date shown on the product
labels.
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8.0 Instructions for use
The following is a sequential outline of the catheterization/implant procedure. The type of diagnostic
catheters, guidewires, dilation balloons, sizing balloons, or other tools needed are at the discretion of the
operator.
8.1 Access site preparation and preimplant diagnostics
1. Perform sterile preparation and draping of the access site.
2. Gain arterial and venous access.
3. Administer heparin to achieve a target ACT of >250 seconds.
4. Introduce a catheter into the arterial sheath and advance it into the ascending aorta. Perform an
aortogram to demonstrate the coronary arteries are not adjacent to the RVOT and that there is no risk
of coronary compression when a stent or a TPV is implanted.
If the coronaries appear to be in close proximity to the implant site, and coronary compression
appears to be possible, further investigations should be done before moving forward with TPV
implantation.
Having covered stents available during preparation of the implant site can be of use in
containing ruptured or dissected right ventricular outflow tract conduit injury should it occur
during preparation for TPV implant.
5. Advance an angiographic catheter to the right ventricle (RV) or proximal part of the RVOT for
angiography. The angiographic projections obtained will be based on the relative position of the
RVOT.
If assessing a bioprosthesis, adjust the fluoroscopy angles so the bioprosthesis annulus and/or
commissures are in one plane or in profile. Consider the features of the bioprosthesis when
determining the optimal placement for the TPV.
6. To assess for suitability of TPV implantation, follow either step a (for conduits) or step b (for
bioprosthetic valves).
a. For conduits: Obtain angiographic measurements of the intended implantation site to assess
suitability of the conduit for TPV implantation. If the angiographic measurements are unclear
or if there is question of the conduit being compliant, a low-pressure sizing balloon
(<811 kPa [<8 atm]) may be used to further assess the current condition of the conduit. If the
narrowest conduit dimension (usually in the lateral projection) is ≤18 mm and less than the
original conduit diameter, predilate the site of conduit obstruction (the implantation site) to
facilitate optimal relief of conduit obstruction. The size of the predilation balloon should be
at least 2 mm greater than the narrowest diameter of the conduit in any projection, no more
than 110% of the nominal conduit diameter. Perform another conduit angiogram to ensure
the conduit is intact. If there is no conduit injury, repeat the predilation steps, using the same
guidelines with increasingly larger balloons until appropriate implant diameter has been
reached.
b. For bioprosthetic valves: Obtain angiographic measurements of the intended implantation
site to assess suitability for TPV implantation. If angiographic measurements are unclear or if
there is a question of the inner diameter (ID) of the bioprosthesis being too large for implant
(>22 mm), a low-pressure sizing balloon (<811 kPa [<8 atm]) may be used to further assess
the ID. If the current ID of the bioprosthesis is <22 mm and is ≥2 mm less than the
manufacturer’s published ID, use a balloon to predilate the bioprosthesis. The balloon should
12
not exceed the manufacturer’s published ID of the bioprosthesis. If the bioprosthesis ID
measures >22 mm, the bioprosthesis should be considered too large for Melody™ TPV
implantation.
Note: If obstruction is noted, further preparation of the implantation site (for example, predilation)
may be required to facilitate optimal relief of obstruction before implanting the TPV.
7. Perform final sizing using a balloon diameter that clearly demonstrates the narrowest portion of the
conduit or bioprosthesis (at a pressure of <811 kPa [<8 atm]). If the coronary arteries are an
acceptable distance from the implant site, the anatomy is considered suitable for Melody™ TPV
implantation. See Table 1 for sizing recommendations.
If questions about the coronary anatomy remain, repeat an aortic root angiogram or perform
a selective coronary angiogram of the coronary system close to the conduit while
simultaneously inflating the sizing balloon or largest predilation balloon to full expansion. If a
coronary artery appears to be compressed by the balloon, the patient has unsuitable anatomy
for the TPV, and the procedure should be abandoned.
8. Place a guidewire across the RVOT with its tip located as far distal in the pulmonary arterial bed as
possible. Remove the diagnostic catheter. Leave the dilator in place and prepare the TPV and the
delivery system.
8.2 Preparation of the TPV
1. Before opening, carefully examine the jar and lid for damage, leakage, or broken seals. The jar
should contain enough sterilant to cover the TPV. Rinse the TPV for a minimum of 2 minutes
to reduce the glutaraldehyde concentration from the TPV as directed in the following steps.
a. Using aseptic technique, prepare 3 sterile bowls; 1 remaining empty and 2 containing
isotonic saline solution (500 mL) for rinsing.
b. Using aseptic technique, remove the TPV by grasping the serial number tag with atraumatic
forceps and lifting it from the jar. The outside of the jar is nonsterile. Do not allow the TPV
to come into contact with the outside of the jar.
c. A serial number tag is sutured to the outflow aspect of the TPV. Verify that the serial number
on the tag matches the jar label serial number and the serial number on the patient
registration form. If any differences in serial number are noted, do not use the TPV. Do not
detach the tag from the TPV until implantation is imminent.
d. Drain the residual storage solution from the valve into the empty discard bowl (bowl 1) by
holding the TPV with the serial tag (outflow end) downward.
e. Transfer the empty TPV to the rinse bowl (bowl 2). Fill the TPV with rinse solution and
alternately empty and fill by inverting and swirling, emptying and filling the valve for
1 minute, then empty the solution from the valve into the bowl.
f. Transfer the empty TPV to the rinse bowl (bowl 3) and repeat step e for a minimum of
1 minute. Leave the TPV in the rinse bowl until implantation is imminent to prevent the
tissue from drying.
g. Empty the rinse solution from the TPV before loading the TPV onto the delivery system.
2. Remove the serial number tag by cutting the suture, which attaches the tag to the TPV.
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8.3 Delivery system loading and placement of the TPV
1. Carefully examine the delivery system to confirm it was not damaged in shipment, and the balloon
size is suitable for the intended procedure. The size of the delivery system to be used is based on the
prepared implant site, as described in Table 1. The delivery system used should contain a TPV
delivery balloon that is 0 to 2 mm larger than the waist at the implant site, but no more than 110% of
the nominal conduit or bioprosthetic valve diameter.
2. Flush the delivery system guidewire lumen and the side port. Prepare the balloons by completely
deflating with a syringe. Connect inflation syringes to the inner and outer balloon lumens. Inflation
devices with pressure monitoring capabilities are recommended. Use a solution ratio of one-third to
two-thirds contrast to saline in the inflation syringes.
3. Reduce the size of the TPV while crimping it using mandrels of decreasing size. It is recommended
to use a 2.5 mL sterile syringe for crimping to an intermediate size prior to final crimping onto the
balloon catheter. When reduced to the intermediate size, slide the TPV over the tip of the delivery
system and center over the balloons.
4. Verify that the outflow end of the TPV is oriented toward the distal end of the delivery system. The
outflow end of the TPV can be detected by the blue suture used to attach the valve at this location.
5. Gently crimp the TPV onto the balloon using finger pressure and a rolling action to exert equal
pressure on all sides of the TPV to elongate the stent. Crimp only until no movement is felt on the
delivery system.
Avoid bending or twisting the TPV.
Ensure the blue suture is adjacent to the blue tip of the delivery system to ensure proper
orientation of the TPV for delivery.
6. Carefully slide the sheath over the TPV and balloons, ensuring that the crowns at the inflow end of
the TPV do not get caught on the sheath as it is advanced over the TPV. Flush the sheath using the
sidearm to remove air from the delivery system. Continue advancing the sheath and flushing until
the sheath fits snugly over the proximal end of the blue tip.
Note: Check to ensure that the blue suture is adjacent to the blue tip of the delivery system.
7. Remove the venous dilator from the access site, and advance the delivery system over the guidewire.
Carefully introduce the delivery system through the skin and advance it toward the implantation site.
Should bleeding be noted at the venous access site, advance the sleeve on the proximal end of the
shaft into the vein to stop the bleeding. Advance the delivery system to the site where the TPV is
intended to be deployed. This requires manipulations of the delivery system and the guidewire.
Maintain adequate guidewire position at all times.
8. Uncover the TPV once it has reached the level of the implantation site. Hold the shaft of the delivery
system in place while pulling back on the outer sheath. The TPV is fully uncovered when the
flushing port of the outer sheath is aligned with the proximal marker on the delivery system shaft.
While uncovering, ensure that there is no inadvertent movement of the TPV, which could possibly
lead to the loss of the appropriate TPV position.
9. Once the TPV is fully uncovered, connect a syringe with pure contrast to the flush port of the
delivery system. Inject a small amount of contrast to confirm good position of the TPV and full
retraction of the sheath. Further minor adjustments of the position of the TPV are still possible at this
point.
10. Inflate the inner balloon followed by the outer balloon. Once the TPV is properly deployed against
the implantation site, deflate the balloons and carefully remove the delivery system.
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Size 18 mm
5
506
1
101
17.9
2
203
18.6
3
304
19.4
4 (RBP)
405
20.1
Size 20 mm
5
506
1
101
19.7
2
203
20.7
3
304
21.7
4 (RBP)
405
22.4
Size 22 mm
Outer: 22 mm × 4 cm
4.5
456
1
101
21.8
2
203
22.8
3 (RBP)
304
24.1
Notes:
4. kPa = kilopascal
18 mm
33 mm
26 mm
20 mm
32 mm
24 mm
22 mm
32 mm
21 mm
Note: Data on file
11. Measure the RV-PA pressure. If a significant gradient exists, perform balloon dilation with a high-
pressure balloon in order to minimize the gradient.
12. Compare the RV pressure with the systemic pressure measured through the arterial approach.
13. Perform a contrast injection into the proximal main PA (or distal RVOT) to demonstrate valve
function and position. Ensure that the valve is not held open by the guidewire and the delivery
system as this would give the false impression of pulmonary regurgitation.
14. Remove the catheters, guidewires, and sheaths while maintaining hemostasis.
Note: The delivery system is for single use and should only be inflated once. Do not use the delivery
system to expand the TPV after initial implantation. The TPV may be expanded after placement by
using a different balloon catheter. To minimize the risk of creating regurgitation, do not exceed the
maximum recommended size as shown in Table 1.
Note: Circumferential tearing of the delivery balloon catheter prior to complete expansion of the
TPV may cause the balloon to become tethered to the TPV, requiring surgical removal. In case of
rupture of an adequately sized balloon after TPV expansion, the balloon can be withdrawn and a new
balloon catheter can be exchanged over a guidewire to complete expansion of the TPV.
Table 3: Melody™ TPV sizing chart
Delivery system size –
inner balloon /
outer balloon
atm kPa atm kPa
Inner: 9 mm × 3.5 cm /
Outer: 18 mm × 4 cm
Inner: 10 mm × 3.5 cm /
Outer: 20 mm × 4 cm
Inner: 11 mm × 3.5 cm /
1. Do not exceed bolded pressure values for either the inner or outer balloon of the delivery system size.
2. RBP = rated burst pressure = maximum applied pressure
3. atm = atmosphere
Table 4: Approximate length of the TPV following deployment with the corresponding delivery
Inner balloon
maximum
applied
pressure (RBP)
system
Outer balloon
applied pressure
Corresponding TPV
outside diameter
(mm) (balloon
inflated)
Expanded outer balloon
outer diameter (OD) size
Reference TPV length
(crimped/loaded on
delivery system)
15
Reference TPV length
(after balloon deflation)
16
9.0 Return of explanted TPVs
Medtronic is interested in obtaining recovered explanted TPVs. Specific pathological studies of the
explanted TPV will be conducted under the direction of a consulting pathologist. A written summary of
the findings will be returned to the physician upon request. To obtain a product return kit, contact a
Medtronic distribution center or a Medtronic Representative. If a kit is not available, place the explanted
TPV in a container of glutaraldehyde or 10% buffered formalin immediately after excision. For further
instructions on the return of an explanted device, contact a Medtronic Representative.
17
10.0 Clinical studies
Two prospective, nonrandomized, multicenter studies were conducted for Melody TPV™. Section 10
presents the clinical datasets of the long-term follow-up Post Approval Study (PAS) (Section 10.1) and
the new-enrollment PAS (Section 10.2). The pooled data of both studies is also provided (Section 10.3).
10.1 Melody™ TPV Long-term Follow-up Post Approval Study (PAS)
The Melody™ TPV Long-term Follow-up PAS is a prospective, nonrandomized, multicenter
investigational study being conducted at 5 centers in the United States. The study consists of subjects
who received the implant during the premarket investigational device exemption (IDE) trial, hereafter
referred to as the long-term follow up post-approval study (PAS). The purpose of this clinical study is to
confirm the long-term functionality of transcatheter implantation of the Medtronic Melody™ TPV in
dysfunctional RVOT conduits.
The primary outcome measure is TPV dysfunction at 5 years after TPV implant, which is a composite
outcome defined as RVOT reoperation for conduit dysfunction or device-related reasons, catheter
reintervention on the TPV, or hemodynamic dysfunction of the TPV (moderate or greater pulmonary
regurgitation, and/or a mean RVOT gradient greater than 40 mm Hg). The secondary outcome measures
include (1) freedom from TPV dysfunction at 10 years; (2) procedural success; (3) safety including
serious procedural adverse events, serious device-related adverse events, stent fracture, catheter
reintervention on the TPV, surgical replacement of the RVOT conduit, and death (all-cause, procedural,
and device-related); (4) clinical utility (New York Heart Association [NYHA] classification).
An independent Data Safety Monitoring Board (DSMB), Clinical Events Committee (CEC), and
imaging core laboratory were utilized in the long term follow up PAS trial through humanitarian device
exemption (HDE) approval in 2010. All subjects had imaging data through 1 year analyzed by the
imaging core laboratory. A cardiopulmonary exercise testing (CPET) core laboratory was utilized for
review and interpretation of CPET exams through 5 years. The Long-term Follow-up PAS study
continues to use an independent pathology core laboratory to analyze explanted devices.
A total of 171 subjects were enrolled in this study between January 31, 2007 and January 12, 2010. The
following data are interim results current through June 2016. In total, 167 subjects underwent
catheterization for potential implantation of the Melody™ TPV, with 150 subjects subsequently
receiving the valve. The mean length of follow-up was 73.0 ± 20.6 months.
18
Gender
Female
37.4% (64/171)
Male
62.6% (107/171)
Age (years) n 171
Mean ± SD
21.8 ± 9.8
Median [min, max]
19.0 [7.0, 53.0]
Original diagnosis
Aortic valve disease (Ross)
20.5% (35/171)
Double outlet right ventricle
4.7% (8/171)
Isolated pulmonary stenosis
1.8% (3/171)
Pulmonary atresia
0.6% (1/171)
Tetralogy of Fallot
50.3% (86/171)
Transposition of the great arteries
10.5% (18/171)
Truncus arteriosus
10.5% (18/171)
Other1
1.2% (2/171)
RVOT conduit type
Homograft
73.7% (126/171)
Biological valved conduit
15.8% (27/171)
Bioprosthesis
4.7% (8/171)
Synthetic
5.8% (10/171)
Other
0.0% (0/171)
RVOT conduit size (mm) when originally implanted
n
163
Mean ± SD
21.0 ± 2.6
Median [min, max]
21.0 [11.0, 28.0]
Bioprosthesis size (mm) when originally implanted
n 8 Mean ± SD
21.6 ± 2.3
Median [min, max]
22.0 [18.0, 25.0]
1
Other original diagnoses included: double outlet right ventricle (DORV) with malposed great arteries,
defect (ASD) (n = 1).
10.1.1 Subject demographics
Table 5 presents the subject demographics and baseline characteristics analyzed for enrolled subjects.
The study population consisted of 107 male and 64 female subjects with a mean age of 21.8 ± 9.8 (range
7 to 53 years). Tetralogy of Fallot was the most common original diagnosis (50.3%), followed by aortic
valve disease in subjects having undergone a Ross procedure (20.5%).
Table 5: Long-term Follow-up PAS: subject demographics/baseline data –
enrolled cohort (N = 171)
Assessment Enrolled cohort (N = 171)
ventricular septal defect (VSD), and coarctation of the aorta (n = 1); pulmonary stenosis with atrial septal
19
Anesthesia
Local
0.0% (0/167)
General
100.0% (167/167)
Venous site access
Femoral vein
94.6% (158/167)
Internal jugular vein
4.8% (8/167)
Subclavian vein
0.6% (1/167)
Concomitant procedures1
No concomitant procedures
59.3% (99/167)
Stent placement, peripheral PA
4.2% (7/167)
Balloon angioplasty, peripheral PA
4.8% (8/167)
Stent placement, RVOT conduit
32.3% (54/167)
Placement of intravascular coil
0.6% (1/167)
Closure of ASD or PFO
0.6% (1/167)
Closure of VSD
0.0% (0/167)
Other2
4.8% (8/167)
Total fluoroscopy time (minutes)
n
165
Mean ± SD
43.6 ± 21.7
Median [min, max]
40.0 [9.0, 131.0]
Total procedure time (minutes)
n
165
Mean ± SD
174.1 ± 65.5
Median [min, max]
167.0 [34.0, 448.0]
Length of hospital stay (days)
n
165
Mean ± SD
1.2 ± 0.9
Median [min, max]
1.0 [0.0, 7.0]
1
Subjects may have had more than one concomitant procedure.
(n = 1), balloon angioplasty and interposition conduit-right pulmonary artery (RPA) graft (n = 1).
10.1.2 Procedural data
A summary of procedural data is provided in Table 6. The percutaneous femoral venous approach was
used in the majority of subjects (94.6%); however, in some patients, internal jugular vein (4.8%) or
subclavian vein (0.6%) access was used. Concomitant procedures were not allowed per the CIP in the
first 35 subjects of the long term follow up PAS trial. Following revision of the CIP to allow for
concomitant procedures, pre-stenting of the RVOT was the most commonly performed concomitant
procedure (n = 54).
Table 6: Long-term Follow-up PAS: procedural data – catheterized cohort (N = 167)
Assessment Catheterized cohort (N = 167)
2
Other concomitant procedures included: electrophysiology study (n = 3), stenting of the inferior vena cava
(n = 1), aneurysm closure (n = 1), transesophageal echocardiography (n = 1), coronary artery stenting
20
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