Implantable medical device with visual orientation indicator

Abstract

An implantable medical device adapted to be implanted in an implantation site can be implanted in a plurality of rotational orientations at the implantation site. The implantable medical device includes an expandable body adapted to expand from a collapsed form for delivery to an expanded form for deployment, and a radiopaque indicator disposed relative to the expandable body. The radiopaque indicator is adapted to present a first appearance when viewed in a first rotational orientation and to present a second appearance different from the first appearance when viewed in a second rotational orientation different from the first rotational orientation. As an example, the implantable medical device can be a catheter-delivered replacement aortic valve.

Description

Technical Field

[0001] The present disclosure relates to medical devices and methods for manufacturing and using medical devices. More specifically, the present disclosure relates to an implantable medical device having a visual orientation indicator that indicates an appropriate direction during and after implantation surgery.

Background Art

[0002] For example, various medical devices have been developed for medical use, such as for accessing body cavities and interacting with fluids and structures within the body cavities. Some of these devices may include guidewires, catheters, pumps, motors, controllers, filters, grinders, needles, valves, and delivery devices and / or systems used to deliver such devices. These devices are manufactured by any one of a wide variety of different manufacturing methods and can be used according to any one of a variety of methods. Known medical devices and methods have respective predetermined advantages and disadvantages.

Summary of the Invention

[0003] The present disclosure provides designs, materials, manufacturing methods, and uses for alternative medical devices. As an example, an implantable medical device is adapted for implantation at an implantation site and is implantable from a plurality of rotational orientations. The implantable medical device includes an expandable body adapted to expand from a collapsed form for delivery to an expanded form for deployment, and an opacity indicator disposed relative to the expandable body, the opacity indicator being adapted to present a first appearance when viewed in a first rotational orientation and a second appearance different from the first appearance when viewed in a second rotational orientation different from the first rotational orientation.

[0004] Alternatively or additionally, the opacity indicator is visible under fluoroscopy, thereby enabling the orientation of the implantable medical device to be indicated while the implantable medical device remains within the delivery device used to deliver the implantable medical device.

[0005] Alternatively or additionally, the radiopacity indicator is visible under fluoroscopy, such that the orientation of the implantable medical device can be indicated even after the implantable medical device has been at least partially deployed from the delivery device.

[0006] Alternatively or additionally, the radiopacity indicator may include a shape mimicking alphanumeric characters. Alternatively or additionally, the radiopacity indicator may include a shape mimicking alphanumeric characters when viewed from the front, and may appear as an asymmetric mirror image of the alphanumeric characters when viewed from the back.

[0007] Alternatively or additionally, the radiopacity indicator may include a linear cross-sectional shape. Alternatively or additionally, the radiopacity indicator may include tantalum. Alternatively or additionally, the implantable medical device may include a replacement heart valve.

[0008] Alternatively or additionally, the replacement heart valve includes a first layer of valve flap and a second layer of valve flap, and the radiopacity indicator may be fixed to the first layer of valve flap or the second layer of valve flap, or both the first layer of valve flap and the second layer of valve flap.

[0009] Alternatively or additionally, the radiopacity indicator may be sutured to the first layer of valve flap or the second layer of valve flap, or both the first layer of valve flap and the second layer of valve flap. Alternatively or additionally, the radiopacity indicator may be disposed between the first layer of valve flap and the second layer of valve flap.

[0010] As another example, there is provided a replacement heart valve adapted to be implanted within a native heart valve annulus and implantable in a plurality of rotational orientations. The replacement heart valve comprises an expandable body adapted to expand from a collapsed form for delivery to an expanded form for deployment, the expandable body including a plurality of replacement valve commissure posts. A valve material is secured to the plurality of replacement valve commissure posts, the valve material forming valve cusps between the plurality of replacement valve commissure posts. An opacity indicator is disposed relative to one of the plurality of replacement valve commissure posts, the opacity indicator being adapted to provide an indication of the rotational orientation of the replacement heart valve relative to the native heart valve annulus.

[0011] Alternatively or additionally, the native heart valve may include an aortic valve. The replacement heart valve may include a replacement aortic valve. The opacity indicator may be adapted to provide an indication of the relative position of each of the plurality of commissure posts relative to the coronary arteries proximate the native aortic valve annulus.

[0012] Alternatively or additionally, the opacity indicator may be secured to the valve material. Alternatively or additionally, the opacity indicator may be sutured to one of the valve material or a replacement valve commissure post, or one of the valve material and a replacement valve commissure post.

[0013] Alternatively or additionally, the opacity indicator may be positioned such that the opacity indicator is visible under fluoroscopy before and during deployment of the replacement heart valve. Alternatively or additionally, the opacity indicator may include a shape mimicking an alphanumeric character when viewed from a front-facing position and may appear as an asymmetric mirror image of the alphanumeric character when viewed from a back-facing position.

[0014] Alternatively or additionally, the shape may include any of a "C" shape, an "E" shape, an "F" shape, a "J" shape, a "K" shape, an "L" shape, a "P" shape, an "R" shape, or a "Z" shape.

[0015] As another example, there is provided a prosthetic aortic valve adapted to be implanted within a native aortic valve, having a plurality of native commissures, and implantable in a plurality of rotational orientations. The prosthetic heart valve includes an expandable body adapted to expand from a collapsed form for delivery to an expanded form for deployment, the expandable body including a plurality of prosthetic valve commissure posts. A first layer of bovine-derived material is disposed on a first side of the plurality of prosthetic valve commissure posts. A second layer of bovine-derived material is disposed on a second side of the plurality of prosthetic valve commissure posts. An opacity indicator is disposed between the first layer of bovine-derived material and the second layer of bovine-derived material, the opacity indicator being adapted to provide an indication of the rotational orientation of the prosthetic aortic valve relative to the native aortic valve.

[0016] Alternatively or additionally, the opacity indicator may include an "L" shape formed from tantalum. The foregoing summary of some embodiments is not intended to describe every disclosed embodiment or every implementation of the present invention. The following drawings and detailed description more specifically exemplify these embodiments.

[0017] The present invention may be more fully understood by considering the following detailed description, which shows various embodiments of the invention in connection with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0018]

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DETAILED DESCRIPTION OF THE INVENTION

[0019] Although the present disclosure is applicable to various modifications and alternative forms, its specific details are illustrated in the drawings and described in detail. However, it should be understood that the intention is not to limit the present disclosure to the specific embodiments described. Rather, it is intended to cover all modifications, equivalents, and alternatives included within the spirit and scope of the present disclosure.

[0020] For the terms defined below, these definitions apply unless different definitions are given in the claims or elsewhere in this specification. In this specification, all numerical values are assumed to be modified by the term "about", whether explicitly stated or not. The term "about" generally refers to a range of numerical values that those skilled in the art would consider equivalent to the recited value (i.e., having the same function or result). In many cases, the term "about" may include values rounded to the nearest significant digit.

[0021] The recitation of a numerical range by endpoints includes all numerical values within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, 5). As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its sense including "and / or" unless the content clearly dictates otherwise.

[0022] The following detailed description should be read with reference to the drawings, which illustrate embodiments and not intended to limit the scope of the invention, in which like reference numerals are used to identify like elements throughout the different figures. The drawings are not necessarily to scale.

[0023] Many implantable medical devices are implanted at various implant sites in a patient. In some cases, at a particular implant site, some implantable medical devices can be implanted in a plurality of acceptable directions. For example, some implantable medical devices can be implanted in a plurality of different rotational orientations due to their structure and overall shape characteristics. The implantable medical device can be implanted such that a particular reference point on the implantable medical device faces any particular rotational position defined on, for example, a 360-degree circumference. The reference point may face a 45-degree direction, a 310-degree direction, or various different directions. In some implantable medical devices, the rotational orientation may not be a problem. In some implantable medical devices, the rotational orientation may be important.

[0024] For ease of explanation, in this disclosure, an implantable medical device is targeted, for example, a transcatheter deliverable replacement heart valve (e.g., a replacement aortic valve). However, the present disclosure is not limited thereto, and the replacement aortic valve described herein is merely exemplary.

[0025] Figures 1A and 1B are side views of an exemplary replacement heart valve 10. The replacement heart valve 10 can be, for example, a replacement aortic valve, a replacement mitral valve, a replacement pulmonary valve, or a replacement tricuspid valve. In some cases, the replacement heart valve 10 may include biological tissue such as porcine or bovine pericardium and / or natural heart valve leaflets such as natural leaflets of a porcine heart valve. In some cases, the natural heart valve leaflets may be attached to a portion of the natural heart wall tissue. The biological material can be fixed, for example, using glutaraldehyde.

[0026] The replacement heart valve 10 includes an expandable frame 12 that is compressible into a radially compressed form, i.e., a collapsed form, for delivery using a delivery catheter and expandable into an expanded form (as shown in the figures) upon implantation. The replacement heart valve 10 includes an expandable frame 12 that is compressible into a radially compressed form or a collapsed form for delivery using a delivery catheter and expandable into an expanded form (as shown in FIG. 1B) upon implantation. The leaflets forming the valve 14 are visible, for example, as shown in FIGS. 2A and 2B (including leaflets 42a, 42b, and 42c).

[0027] In some cases, the expandable frame may include a lower tubular portion or crown 16, an upper crown 18, a plurality of upright struts 20, and a plurality of stabilizing arches 22. In use, the lower portion 16 of the expandable frame 12 can be adapted to be deployed after other regions of the expandable frame 12. For example, the arches 22, struts 20, and upper crown 18 can be deployed at least partially earlier than the lower portion 16 (in this order, reverse order, or different order). At a minimum, when the upper crown 18 is at least partially deployed, the expandable frame 12 is pressed and / or displaced in the direction of arrow 24 to seat the upper crown 18 against the natural leaflets at the implantation site. By deploying the lower portion 16 in a final stage, the expandable frame 12 is fixed in its final position.

[0028] The lower portion 16, and optionally a part of the upper crown 18, may be formed by the stent's lattice structure. The lattice structure may define cells or apertures, for example, generally diamond-shaped apertures. In some cases, the native valve cusp may generally overlap a part 26 of the expansion frame 12. The native valve annulus may overlap a part 28 of the expansion frame.

[0029] The expansion frame 12 may optionally be self-expanding. Such a self-expanding type can be compressed into a compressed form when loaded onto a delivery catheter for delivery to the implantation site. In use, by removing the restraining effect of the sheath that holds the expansion frame 12 in the compressed form, the expansion frame 12 self-expands into or towards the operative form. The self-expanding stent may be composed of, for example, a shape memory material, for example a shape memory alloy, for example nitinol. Alternatively, the expansion frame 12 may be configured to be expanded by the application of a shortening force from the delivery catheter and / or by the application of an expansion force from the delivery catheter, for example using an expansion balloon. These are merely examples.

[0030] In some cases, the relative rotational orientation of the replacement heart valve 10 may be important, particularly in the case of a replacement aortic valve intended to be implanted within the native aortic valve annulus. In some cases, a part of such a replacement heart valve 10 may potentially impede access to the subsequent coronary arteries. In some patients, particularly younger patients, there may be a subsequent need to implant a new replacement aortic valve several years after the initial implantation. In some patients, there may be an immediate or future need to access multiple coronary arteries, for example for performing angioplasty or rotational atherectomy. There may be a need to access multiple coronary arteries for implanting multiple stents. If the initially implanted replacement aortic valve impedes access to the coronary arteries, this can be a problem.

[0031] Figure 2A shows a schematic view of a prosthetic aortic valve 34 implanted within a native aortic valve annulus 36. The prosthetic aortic valve 34 can be regarded as an example of the prosthetic heart valve 10 shown and described in FIGS. 1A and 1B. The prosthetic aortic valve 34 includes an expansion frame 38, which may be equivalent to the expansion frame 12. The expansion frame 38 includes a plurality of commissural posts 40. In some cases, leaflets 42 (shown individually as 42a, 42b, and 42c) are fixed to the commissural posts 40. As shown, coronary arteries 44 and 46 are each connected to the native aortic valve annulus 36.

[0032] Figure 2A shows an improper rotational orientation of the prosthetic aortic valve 34. It can be seen that one of the commissural posts 40 at least partially occludes the coronary artery 44 and another commissural post 40 at least partially occludes the coronary artery 46. Although both the coronary arteries 44 and 46 are shown as being partially occluded, in some cases, the particular positions of the coronary arteries 44 and 46 in some patients result in an improper rotational orientation of the prosthetic aortic valve 34, such that as a result, only one of the coronary arteries 44 and 46 may be at least partially occluded.

[0033] Figure 2B shows a preferred rotational orientation of the prosthetic aortic valve 34, and it can be seen that none of the commissural posts 40 occlude the coronary artery 44 and none of the commissural posts 40 occlude the coronary artery 46. As a result of this rotational orientation, even if a need arises in the future to implant a second prosthetic aortic valve, the prosthetic aortic valve 34 will not cause problems or at least will reduce problems. This also means that access to the coronary arteries 44 and 46 is easy in subsequent procedures such as (but not limited to) angioplasty, rotational atherectomy, stent implantation, etc. performed within the coronary arteries 44 and 46.

[0034] Figure 3 shows a partial schematic view of an exemplary replacement heart valve 48. The exemplary replacement heart valve 48 can be considered as an example of the replacement heart valve 10 shown and described in FIGS. 1A and 1B and / or as an example of the replacement aortic valve 34 shown and described in FIGS. 2A and 2B. The replacement heart valve 48 includes an expansion frame 50 that includes a plurality of commissural posts 52 (only one of which is shown). Optionally, the replacement heart valve 48 includes a first tissue layer 54 and a second tissue layer 56, and by disposing them on respective sides of the commissural posts 52, the commissural posts 52 are sandwiched between the first tissue layer 54 and the second tissue layer 56. Optionally, the first tissue layer 54 and / or the second tissue layer 56 can be considered as part of the tissue forming the valve 14.

[0035] The radiopacity indicator 58 can be disposed between the first tissue layer 54 and the second tissue layer 56. Optionally, the radiopacity indicator 58 can be disposed between the first tissue layer 54 and the commissural post 52 as shown. Optionally, the radiopacity indicator 58 can alternatively be disposed between the commissural post 52 and the second tissue layer 56. Optionally, the radiopacity indicator 58 can be fixed to the commissural post 52. Optionally, the radiopacity indicator 58 can be fixed to one or both of the first tissue layer 54 and the second tissue layer 56. The radiopacity indicator 58 can be fixed in place by adhesion. The radiopacity indicator 58 can be fixed in place by suturing. Optionally, the radiopacity indicator 58 can be fixed in place relative to the commissural post 52 such that the radiopacity indicator 58 is visible under fluoroscopy even while the replacement heart valve 48 is in a compressed form for delivery. Optionally, the radiopacity indicator 58 can be fixed in place relative to the commissural post 52 such that the radiopacity indicator 58 is visible under fluoroscopy even after deployment of the replacement heart valve 48 or during deployment of the replacement heart valve 48.

[0036] The radiopacity indicator 58 can be formed of any suitable radiopaque material that is sufficiently visible under fluoroscopy, for example. In some cases, the radiopacity indicator 58 can be formed of tantalum. In some cases, the radiopacity indicator 58 can be formed of a platinum-iridium mixture or alloy, gold, tungsten, bismuth, or barium. The radiopacity indicator 58 can be formed by cutting and shaping a wire of a suitable material to a predetermined length. By way of non-limiting example, the radiopacity indicator 58 can be formed from a tantalum wire of a predetermined length of 0.020 inches (about 0.508 millimeters) in diameter. In some cases, the radiopacity indicator 58 can be formed of a wire having a square or other linear cross-sectional shape in order to maximize radiopacity (and thus maximize visibility under fluoroscopy).

[0037] In some cases, the radiopacity indicator 58 can have a first appearance when viewed in a first rotational orientation and a second appearance different from the first appearance when viewed in a second rotational orientation different from the first rotational orientation. As an example, the radiopacity indicator 58 can have a shape. The shape can mimic alphanumeric characters when viewed from the front-facing position and can appear as an asymmetric mirror image of the alphanumeric characters when viewed from the back. In some cases, the radiopacity indicator 58 can have any one of a "C" shape, an "E" shape, an "F" shape, a "J" shape, a "K" shape, an "L" shape, a "P" shape, an "R" shape, or a "Z" shape. These are merely examples, and other shapes are contemplated.

[0038] Figures 4 through 6 are fluoroscopic images showing an exemplary replacement aortic valve 60 delivered to a treatment site via a delivery catheter 62. In these images, the treatment site is an artificially created aortic valve implantation site 64, constructed of a polymer tube to be translucent under fluoroscopy. The artificially created aortic valve implantation site 64 includes an element 66. The element 66 carries three markers 66a, 66b, and 66c and mimics the aortic valve annulus and the relative positions of the LCC (left coronary cusp), RCC (right coronary cusp), and NCC (non-coronary cusp). The LCC corresponds to the cusp adjacent to the left coronary artery, and the RCC corresponds to the cusp adjacent to the right coronary artery. One of the coronary arteries 44, 46 shown in FIGS. 2A and 2B corresponds to the left coronary artery, and the other corresponds to the right coronary artery.

[0039] As shown in FIG. 4, the replacement aortic valve 60 is guided to a predetermined position, and the commissural post 68 carries an opacity indicator 70 at a rearward position near its center. In this example, the opacity indicator 70 has an "L" shape. Since the "L" appears correctly as an "L", this means that the aortic valve 60 is currently in the proper rotational orientation. Moving to FIG. 5, the replacement aortic valve 60 has moved to the first stage of post-release position, and the commissural post 68 carries the opacity indicator 70 at the rearward position. Since the "L" appears correctly as an "L", this means that the aortic valve 60 remains in the proper rotational orientation. Moving to FIG. 6, the replacement aortic valve 60 has moved to the second stage of post-release position, and the commissural post 68 carries the opacity indicator 70 at the rearward position. Since the "L" appears correctly as an "L", this means that the aortic valve 60 remains in the proper rotational orientation.

[0040] Figure 7 shows an example where the replacement aortic valve 60 is in an inappropriate rotational orientation. In Figure 7, the replacement aortic valve 60 is in the same delivery stage as that shown in Figure 5. However, in Figure 7, the radiopacity index 70 appears not as an "L" shape but as its mirror image. This means that the replacement aortic valve 60 is rotated with respect to the position shown in Figure 5. For example, the replacement aortic valve 60 shown in Figure 7 may be rotated by approximately 180 degrees from the position shown in Figure 5.

[0041] The devices described herein can be manufactured by essentially any suitable manufacturing technique, including molding, casting, machining, etc., or other appropriate techniques, similar to their various components. Further, the various structures can include materials commonly used in medical devices, such as metals, metal alloys, polymers, metal-polymer composites, ceramics, combinations thereof, etc., or other appropriate materials. These materials can include transparent or translucent materials to improve visibility during treatment. Some examples of suitable metals and metal alloys include stainless steels such as 304V, 304L, 316LV stainless steel, mild steel, nickel-titanium alloys such as linear elastic nitinol or superelastic nitinol, nickel-chromium-molybdenum alloys (e.g., UNS:N06625 (INCONEL® 625), UNS:N06022 (HASTELLOY® C-22), UNS:N10276 (HASTELLOY® C276), other HASTELLOY® alloys, etc.), nickel-copper alloys (e.g., UNS:N04400 (MONEL® 400, NICKELVAC® 400, NICORROS® 400, etc.)), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035 (MP35-N® etc.)), nickel-molybdenum alloys (e.g., UNS:N10665 (HASTELLOY® ALLOYB2)), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten alloys, or nickel alloys such as tungsten alloys, cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003 (ELGILOY®, PHYNOX®, etc.)), platinum-reinforced stainless steel, combinations thereof, etc., or other appropriate materials.

[0042] Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene-tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DuPont's DELRIN®), polyether block ester, polyurethane, polypropylene (PP), polyvinyl chloride (PVC), polyether-ester (e.g., DSM Engineering Plastics' ARNITEL®), ether or ester copolymers (e.g., butylene / poly(alkylene ether) phthalate and / or other polyester elastomers (DuPont's HYTREL®)), polyamide (e.g., Bayer's DURETHAN® or Elf Atochem's CRISTAMID®), elastomeric polyamide, block polyamide / ether, polyether block amide (PEBA, available as PEBAX®, for example), ethylene-vinyl acetate copolymer (EVA), silicone, polyethylene (PE), Marlex high density polyethylene, Marlex low density polyethylene, linear low density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (e.g., EMS American Grilon's GRILAMID®), perfluoro(propyl vinyl ether) (PFA), ethylene-vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), polycarbonate, ionomer, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, etc. thereof.

[0043] It should be understood that this disclosure is, in many respects, merely illustrative. Without exceeding the scope of the present invention, changes may be made in details, particularly with regard to shape, size, and the arrangement of steps. This may include, within appropriate limits, the use of any of the features of one exemplary embodiment in other embodiments. The scope of the present invention is, of course, defined by the language in which the appended claims are expressed.

Claims

1. An implantable medical device adapted to be implanted in an implantation site and capable of being implanted in a plurality of rotational orientations, the implantable medical device comprising: an expandable body adapted to expand from a collapsed form for delivery to an expanded form for deployment, an opacifying indicator disposed on the expandable body, the opacifying indicator being adapted to have a first appearance when viewed in a first rotational orientation and a second appearance different from the first appearance when viewed in a second rotational orientation different from the first rotational orientation.

2. The implantable medical device according to claim 1, wherein the opacifying indicator is visible under fluoroscopy, whereby the orientation of the implantable medical device can be indicated even while the implantable medical device remains within a delivery device used to deliver the implantable medical device.

3. The implantable medical device according to claim 1 or claim 2, wherein the opacifying indicator is visible under fluoroscopy, whereby the orientation of the implantable medical device can be indicated even after the implantable medical device has been at least partially deployed from the delivery device.

4. The implantable medical device according to any one of claims 1 to 3, wherein the opacifying indicator has a shape mimicking alphanumeric characters.

5. The implantable medical device according to any one of claims 1 to 4, comprising a prosthetic heart valve.

6. The prosthetic heart valve comprises a first layer of leaflet material and a second layer of leaflet material, and the opacifying indicator is fixed to the first layer of leaflet material or the second layer of leaflet material, or both the first layer of leaflet material and the second layer of leaflet material. The implantable medical device according to claim 5.

7. The implantable medical device according to claim 6, wherein the opacifying indicator is sutured to the first layer of leaflet material or the second layer of leaflet material, or both the first layer of leaflet material and the second layer of leaflet material.

8. The implantable medical device according to claim 6, wherein the opacifying indicator is disposed between the first layer of leaflet material and the second layer of leaflet material.

9. A prosthetic heart valve adapted to be implanted within a native heart valve annulus and capable of being implanted in a plurality of rotational orientations, the prosthetic heart valve comprising: an expandable body adapted to expand from a collapsed form for delivery to an expanded form for deployment, the expandable body including a plurality of prosthetic valve commissure posts. a valve material secured to the plurality of replacement valve commissure posts, the valve material forming leaflets between the plurality of replacement valve commissure posts; a replacement heart valve comprising an opaque indicator disposed relative to one of the plurality of replacement valve commissure posts, the opaque indicator adapted to provide an indication of a rotational orientation of the replacement heart valve relative to a native heart valve annulus.

10. the native heart valve is an aortic valve; the replacement heart valve is a replacement aortic valve; the opaque indicator is adapted to provide an indication of a relative position of each of the plurality of commissure posts with respect to a coronary artery proximate a native aortic valve annulus.

10. The replacement heart valve of claim 9.

11. 11. The replacement heart valve of claim 9 or claim 10, wherein the opaque indicator is fixed relative to the valve material.

12. 12. The replacement heart valve of claim 9, wherein the opaque marker is sutured to the valve material, or to one of the replacement valve commissure posts, or to the valve material and one of the replacement valve commissure posts.

13. 13. The replacement heart valve of claim 9, wherein the opaque indicia resemble an alphanumeric character when viewed from a frontal position and appear as an asymmetric mirror image of the alphanumeric character when viewed from a rearward position.

14. 1. A replacement aortic valve adapted for implantation within a native aortic valve having a plurality of native commissures and capable of being implanted in a plurality of rotational orientations, the replacement aortic valve comprising: an expandable body adapted to expand from a collapsed configuration for delivery to an expanded configuration for deployment, the expandable body including a plurality of replacement valve commissure posts; a first layer of bovine derived material disposed on a first side of the plurality of replacement valve commissure posts; a second layer of bovine derived material disposed on a second side of the plurality of replacement valve commissure posts; 1. A replacement aortic valve comprising: an opaque indicia disposed between the first layer of bovine-derived material and the second layer of bovine-derived material, the opaque indicia adapted to provide an indication of a rotational orientation of the replacement aortic valve relative to the native aortic valve.

15. 15. The replacement aortic valve of claim 14, wherein the opaque indicator exhibits an "L" shape formed from tantalum.

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