Implantable medical device with visual orientation indication

Abstract

An implantable medical device adapted for implantation at an implantation site, which may be implantable in more than one rotational orientation at the implantation site. The implantable medical device includes an expandable body adapted to expand from a collapsed configuration for delivery to an expanded configuration for deployment, and a radiopaque indicator disposed relative to the expandable body. The radiopaque indicator has a first appearance when viewed in a first rotational orientation and a different second appearance when viewed in a second rotational orientation different from the first rotational orientation. For example, the implantable medical device may be a transcatheter delivered aortic valve replacement.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 359,595, filed on July 8, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0001] The present disclosure relates to medical devices, and methods of making and using medical devices. More particularly, the present disclosure relates to implantable medical devices having visual indicators that show proper orientation during and after implantation. Background Art

[0002] A variety of medical devices have been developed for medical use, for example, for accessing a body cavity and interacting with fluids and structures within the body cavity. Some of these devices may include guidewires, catheters, pumps, motors, controllers, filters, grinders, needles, valves, and delivery devices and / or systems for delivering these devices. These devices are manufactured by any of a variety of different manufacturing methods and can be used according to any of a variety of methods. Among the known medical devices and methods, each has its own specific advantages and disadvantages. Summary of the invention

[0003] The present disclosure provides alternatives in design, materials, manufacturing methods, and use of medical devices. For example, an implantable medical device is suitable for implantation at an implantation site and can be implanted in more than one rotational orientation. The implantable medical device includes an expandable body, which is suitable for expansion from a contracted configuration for delivery to an expanded configuration for deployment; and a radiopaque indicator disposed relative to the expandable body, the radiopaque indicator having a first appearance when viewed in a first rotational orientation and having a different second appearance when viewed in a second rotational orientation different from the first rotational orientation.

[0004] Alternatively or additionally, the radiopaque indicator is visible under fluoroscopy and is thus able to indicate the position of the implantable medical device while it is still within the delivery device used to deliver it.

[0005] Alternatively or additionally, the radiopaque indicator is visible under fluoroscopy and is thus able to indicate the position of the implantable medical device after it has been at least partially deployed from the delivery device.

[0006] Alternatively or additionally, the radiopaque indicator may include a shape that mimics an alphanumeric character.

[0007] Alternatively or additionally, the radiopaque indicator may include a shape that mimics an alphanumeric character when viewed from the front of the shape and may appear as an asymmetrical mirror image of the alphanumeric character when viewed from the back of the shape.

[0008] Alternatively or additionally, the radiopaque indicator may include a rectilinear cross-sectional profile.

[0009] Alternatively or additionally, the radiopaque indicator may comprise tantalum.

[0010] Alternatively or additionally, the implantable medical device may include a heart valve replacement.

[0011] Alternatively or additionally, the heart valve replacement may include a first layer of valve leaflet material and a second layer of valve leaflet material, and the radiopaque indicator may be secured to the first layer and / or the second layer of valve leaflet material.

[0012] Alternatively or additionally, radiopaque indicators may be sutured to the first and / or second layers of valve leaflet material.

[0013] Alternatively or additionally, a radiopaque indicator may be disposed between the first layer of valve leaflet material and the second layer of valve leaflet material.

[0014] Another example is a heart valve replacement suitable for implantation within a native heart valve annulus and capable of being implanted in more than one rotational orientation. The heart valve replacement includes an expandable body suitable for expansion from a contracted configuration for delivery to an expanded configuration for deployment, the expandable body including a plurality of replacement valve commissure posts. Valve material is fixed relative to the plurality of replacement valve commissure posts, and the valve material forms a valve cusp between adjacent posts of the plurality of replacement valve commissure posts. A radiopaque indicator is disposed relative to one of the plurality of replacement valve commissure posts, the radiopaque indicator being suitable for providing an indication of the rotational orientation of the heart valve replacement relative to the native heart valve annulus.

[0015] Alternatively or additionally, the native heart valve may include an aortic valve, the heart valve replacement may include an aortic valve replacement, and the radiopaque 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.

[0016] Alternatively or additionally, the radiopaque indicator may be fixed relative to the valve material.

[0017] Alternatively or additionally, a radiopaque indicator may be sutured to the valve material and / or one of the replacement valve commissure posts.

[0018] Alternatively or additionally, the radiopaque indicator may be positioned such that the radiopaque indicator is visible under fluoroscopy prior to and during deployment of the heart valve replacement.

[0019] Alternatively or additionally, the radiopaque indicator may include a shape that mimics an alphanumeric character when viewed from a position in front of the shape and may appear as an asymmetrical mirror image of the alphanumeric character when viewed from a position behind the shape.

[0020] As an alternative or addition, the shape may include one of a "C", "E", "F", "J", "K", "L", "P", "R" or "Z" shape.

[0021] Another example is an aortic valve replacement suitable for implantation in a native aortic valve having a plurality of native commissure posts and capable of being implanted in more than one rotational orientation. The aortic valve replacement includes an expandable body suitable for expansion from a contracted 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 valve material is disposed on a first side of the plurality of replacement valve commissure posts. A second layer of bovine valve material is disposed on a second side of the plurality of replacement valve commissure posts. A radiopaque indicator is disposed between the first layer of bovine valve material and the second layer of bovine valve material, the radiopaque indicator being suitable for providing an indication of the rotational orientation of the aortic valve replacement relative to the native aortic valve.

[0022] Alternatively or additionally, the radiopaque indicator may include an "L" shape formed from tantalum.

[0023] The above summary of some embodiments is not intended to describe every disclosed embodiment or every implementation of the present disclosure. The following figures and detailed description will illustrate these embodiments in more detail. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The present invention may be more fully understood by considering the following detailed description of various embodiments of the invention in conjunction with the accompanying drawings, in which:

[0025] Figure 1A is a view of an exemplary aortic valve replacement expandable frame;

[0026] Figure 1B Yes Figure 1A A view of an exemplary aortic valve replacement with a mid-expandable frame;

[0027] Figure 2A is a schematic diagram of the misalignment of the aortic valve replacement relative to the native aortic valve;

[0028] Figure 2B is a schematic diagram of the correct alignment of the aortic valve replacement with the native aortic valve;

[0029] Figure 3 is a schematic diagram of a portion of an exemplary aortic valve replacement, including tissue layers, a radiopaque indicator, and a portion of an expandable frame;

[0030] Figure 4 is a fluoroscopic image of an exemplary aortic valve replacement within its delivery device tracked and positioned relative to a schematically illustrated native aortic valve annulus;

[0031] Figure 5 yes Figure 4 fluoroscopic image of an exemplary aortic valve replacement showing proper alignment of the aortic valve replacement with the native aortic valve annulus after a first stage of release of the aortic valve replacement from its delivery device;

[0032] Figure 6 yes Figure 4 fluoroscopic image of an exemplary aortic valve replacement showing proper alignment of the aortic valve replacement with the native aortic valve annulus after a second stage of release of the aortic valve replacement from its delivery device;

[0033] Figure 7 yes Figure 4 Fluoroscopic image of an exemplary aortic valve replacement in , showing that the aortic valve replacement is not properly aligned with the native aortic valve annulus after a first stage of release of the aortic valve replacement from its delivery device.

[0034] Although the present disclosure may be subjected to various modifications and alternative forms, its specific contents have been shown by way of example in the accompanying drawings and will be described in detail. However, it should be understood that its purpose is not to limit the present disclosure to the specific embodiments described. On the contrary, its purpose is to cover all modifications, equivalents and alternatives that fall within the spirit and scope of the present disclosure. DETAILED DESCRIPTION

[0035] For the following defined terms, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification.

[0036] All numerical values ​​herein are assumed to be modified by the term "about", whether or not explicitly stated. The term "about" generally refers to a range of numbers that one skilled in the art considers to be equivalent to the stated value (i.e., having the same function or result). In many cases, the term "about" may include numbers that are rounded to the nearest significant figure.

[0037] The recitation of numerical ranges by endpoints includes all numbers within that range (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0038] As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural references 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.

[0039] The following detailed description should be read in conjunction with the accompanying drawings, in which similar elements in different drawings are numbered the same. The accompanying drawings are not necessarily drawn to scale, depict exemplary embodiments, and are not intended to limit the scope of the invention.

[0040] Many implantable medical devices are implanted in a variety of different implantation sites within a patient's body. In some cases, some implantable medical devices are capable of being implanted in more than one possible orientation at a particular implantation site. For example, some implantable medical devices, based on their construction or overall shape, may be capable of being implanted in more than one rotational orientation. An implantable medical device may be implanted in such a way that a particular reference point on the device, for example, may be oriented toward any particular rotational point defined along a 360 degree circle. The reference point may be oriented toward a 45 degree orientation, or it may be oriented toward a 310 degree orientation, or any different orientation. For some implantable medical devices, the rotational orientation may not be important. But for some implantable medical devices, the rotational orientation may be important.

[0041] For ease of description, the present disclosure is directed to an implantable medical device that is a heart valve replacement, such as an aortic valve replacement, which can be delivered via a catheter. However, the present disclosure is not intended to be limited thereto, as the aortic valve replacement described herein is merely exemplary.

[0042] Figure 1A and Figure 1B is a side view of an exemplary heart valve replacement 10. The heart valve replacement 10 can be an aortic valve replacement, a mitral valve replacement, a pulmonary valve replacement, or a tricuspid valve replacement. In some cases, the heart valve replacement 10 can include biological tissue, such as porcine or bovine pericardium, and / or native heart valve leaflets, such as native porcine heart valve leaflets. In some cases, the native heart valve leaflets can be attached to a portion of native heart wall tissue. The biological material can be fixed, for example, using glutaraldehyde.

[0043] The heart valve replacement 10 includes an expandable frame 12 that can be compressed into a radially compressed or collapsed configuration for delivery using a delivery catheter and can be expanded to an expanded configuration (as shown) during implantation. The heart valve replacement 10 can include a plurality of leaflets (e.g., Figure 1B The leaflets defining the valve 14 are shown in FIG. Figure 2A and Figure 2B(including leaflets 42a, 42b and 42c).

[0044] In some cases, the expandable frame can include a lower tubular or crown portion 16, an upper crown portion 18, a plurality of upright commissure posts 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 areas of the expandable frame 12. For example, the arches 22, the support portions 20, and the upper crown portion 18 can be deployed at least partially before the lower portion 16 (in this order, or in the reverse order, or in a different order). At least, once the upper crown portion 18 is at least partially deployed, the expandable frame 12 can be pushed and / or moved in the direction of arrow 24 to position the upper crown portion 18 against the native leaflets of the implantation site. Finally, the lower portion 16 is deployed to secure the expandable frame 12 in its final position.

[0045] The lower portion 16, and optionally a portion of the upper coronary portion 18, may be formed by a lattice structure of the stent. The lattice structure may, for example, define cells or holes, typically diamond-shaped holes. In some cases, the native leaflets may generally overlap a portion 26 of the expandable frame 12. The native valve ring may overlap a portion 28 of the expandable frame.

[0046] The expandable frame 12 can optionally be self-expanding, which can be compressed into a compressed configuration so as to be loaded into a delivery catheter and delivered to an implantation site. In use, the expandable frame 12 self-expands to or tends to an operational configuration by removing the restraining effect of the sheath that holds the expandable frame 12 in a compressed configuration. The self-expanding stent can, for example, be made of a shape memory material, such as a shape memory metal alloy, such as nitinol. Alternatively, the expandable frame 12 can be configured to expand by applying a shortening force from a delivery catheter and / or by applying an expansion force from a delivery catheter (e.g., using an expansion balloon). These are merely examples.

[0047] In some cases, the relative rotational orientation of the heart valve replacement 10 may be important, particularly when the heart valve replacement 10 is an aortic valve replacement intended to be implanted within the native aortic valve annulus. In some cases, portions of the heart valve replacement 10 may potentially interfere with subsequent access to the coronary arteries. In some patients, particularly younger patients, a new aortic valve replacement may need to be implanted several years after the initial implantation. In some patients, access to one or more coronary arteries may be required immediately or at some time in the future for procedures such as angioplasty or rotational ablation. Access to one or more coronary arteries may be required to implant one or more stents. This may be problematic if the initially implanted aortic valve replacement interferes with access to the coronary arteries.

[0048] Figure 2AA schematic diagram of an aortic valve replacement 34 implanted within a native aortic valve annulus 36 is shown. The aortic valve replacement 34 can be viewed as Figure 1A and Figure 1B An example of a heart valve replacement 10 shown and described in . An aortic valve replacement 34 includes an expandable frame 38, which can be similar to the expandable frame 12. The expandable frame 38 includes several commissure posts 40. In some cases, valve leaflets 42 (labeled 42a, 42b, and 42c) are fixed relative to the commissure posts 40. As shown, coronary arteries 44 and 46 are respectively connected to the native aortic valve annulus 36.

[0049] Figure 2A The rotational malposition of aortic valve replacement 34 is illustrated, as one of the commissure posts 40 can be seen to at least partially occlude coronary artery 44, while the other commissure post 40 can at least partially occlude coronary artery 46. Although both coronary arteries 44 and 46 are shown as partially occluded, in some cases, the particular position of coronary arteries 44 and 46 in some patients may mean that the rotational malposition of aortic valve replacement 34 may result in only one of coronary arteries 44 and 46 being at least partially occluded.

[0050] Figure 2B The optimal rotational orientation of the aortic valve replacement 34 is illustrated, as it can be seen that none of the commissure posts 40 obstructs the coronary artery 44, nor does one of the commissure posts 40 obstruct the coronary artery 46. Due to this rotational orientation, the aortic valve replacement 34 will not cause problems, or at least should cause fewer problems, if a second aortic valve replacement needs to be implanted in the future. This also means that the coronary arteries 44 and 46 are easily accessible for any subsequent procedures performed within the coronary arteries 44 and 46 (such as, but not limited to, angioplasty, rotational ablation, or stent implantation).

[0051] Figure 3 is a schematic diagram of a portion of an exemplary heart valve replacement 48. The exemplary heart valve replacement 48 can be viewed as Figure 1A and Figure 1B The heart valve replacement 10 shown and described in, and / or Figure 2A and Figure 2B An example of an aortic valve replacement 34 is shown and described in . A heart valve replacement 48 includes an expandable frame 50 that includes a plurality of commissure posts 52 (only one is shown). In some cases, the heart valve replacement 48 includes a first tissue layer 54 and a second tissue layer 56 that are disposed on either side of the commissure posts 52, thereby sandwiching the commissure posts 52 between the first tissue layer 54 and the second tissue layer 56. In some cases, the first tissue layer 54 and / or the second tissue layer 56 can be considered to be part of the tissue that forms the valve 14.

[0052] The radiopaque indicator 58 can be disposed between the first tissue layer 54 and the second tissue layer 56. In some cases, the radiopaque indicator 58 can be disposed between the first tissue layer 54 and the commissure post 52 as shown. In some cases, the radiopaque indicator 58 can be disposed between the commissure post 52 and the second tissue layer 56. In some cases, the radiopaque indicator 58 can be fixed to the commissure post 52. In some cases, the radiopaque indicator 58 can be fixed to one or both of the first tissue layer 54 and the second tissue layer 56. The radiopaque indicator 58 can be fixed in place by an adhesive. The radiopaque indicator 58 can be sutured in place. In some cases, the radiopaque indicator 58 can be fixed in place relative to the commissure post 52 so that the radiopaque indicator 58 is visible under fluoroscopy when the heart valve replacement 48 is in a compressed configuration for delivery. In some cases, the radiopaque indicator 58 can be fixed in place relative to the commissure posts 52 so that the radiopaque indicator 58 is visible under fluoroscopy after deployment of the heart valve replacement 48 or even during deployment of the heart valve replacement 48.

[0053] The radiopaque indicator 58 can be formed, for example, of any suitable radiopaque material that is sufficiently visible under fluoroscopy. In some cases, the radiopaque indicator 58 can be formed of tantalum. In some cases, the radiopaque indicator 58 can be formed of a platinum-iridium mixture or alloy, gold, tungsten, bismuth, or barium. The radiopaque indicator 58 can be formed by cutting and forming a section of wire of a suitable material. As an illustrative but non-limiting example, the radiopaque indicator 58 can be formed by a section of tantalum wire having a diameter of 0.020 inches. In some cases, the radiopaque indicator 58 can be formed of a wire having a square or otherwise rectilinear cross-sectional profile to maximize linear opacity (thereby maximizing visibility during fluoroscopy).

[0054] In some cases, the radiopaque indicator 58 can have a first appearance when viewed in a first rotational orientation and a different second appearance when viewed in a second rotational orientation different from the first rotational orientation. For example, the radiopaque indicator 58 can have a shape that mimics an alphanumeric character when viewed from a position in front of the shape and appear as an asymmetric mirror image of the alphanumeric character when viewed from a position behind the shape. In some cases, the radiopaque indicator 58 can have a shape such as 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 examples only and other shapes are also contemplated.

[0055] Figures 4 to 6are fluoroscopic images showing an exemplary aortic valve replacement 60 being delivered to a treatment site via a delivery catheter 62. In these images, the treatment site is an artificial aortic valve implant site 64, which is composed of a polymer tube and is translucent under fluoroscopy. The artificial aortic valve implant site 64 includes an element 66 with three markers 66a, 66b and 66c, simulating the relative positions of the aortic valve annulus and the left coronary valve leaflet (LCC), the right coronary valve leaflet (RCC) and the non-coronary valve leaflet (NCC). The LCC corresponds to the valve leaflet close to the left coronary artery, and the RCC corresponds to the valve leaflet close to the right coronary artery. Figure 2A and Figure 2B One of the coronary arteries 44 and 46 shown in FIG. 4 corresponds to the left coronary artery, while the other coronary artery corresponds to the right coronary artery.

[0056] like Figure 4 As shown, the aortic valve replacement 60 has been tracked and positioned with the radiopaque indicator 70 on the commissure posts 68 in a mid-posterior position. In this example, the radiopaque indicator 70 is in the shape of an "L". Since the "L" looks correct, this means that the aortic valve replacement 60 is currently in the proper rotational orientation. Go to Figure 5 , the aortic valve replacement 60 has moved to the first stage post-release position, and the radiopaque indicators 70 on the commissure posts 68 are in the posterior position. Since the "L" still looks correct, this means that the aortic valve 60 is still in the proper rotational orientation. Go to Figure 6 , the aortic valve replacement 60 has moved to the post-release second stage position, and the radiopaque indicators 70 on the commissure posts 68 are in the posterior position. Since the "L" still looks correct, this means that the aortic valve 60 is still in the proper rotational orientation.

[0057] Figure 7 An example of a poorly rotated aortic valve replacement 60 is given. Figure 7 In the embodiment, the aortic valve replacement 60 is in a Figure 5 However, in Figure 7 In FIG. 1 , the radiopaque indicator 70 does not appear to be an “L” shape, but rather a mirror image thereof. This means that the aortic valve replacement 60 is positioned relative to Figure 5 The positions shown in are rotated. For example, Figure 7 The aortic valve replacement 60 shown in FIG. Figure 5 The position shown in is rotated approximately 180 degrees.

[0058] The devices described herein and their various components can be manufactured substantially according to any suitable manufacturing technique, including molding, casting, machining, etc., or any other suitable technique. In addition, the various structures can include materials generally associated with medical devices, such as metals, metal alloys, polymers, metal-polymer composites, ceramics, combinations thereof, etc., or any other suitable material. These materials can include transparent or translucent materials to assist in visualization during surgical procedures. Some examples of suitable metals and metal alloys include stainless steels, such as 304V, 304L, and 316LV stainless steel; low carbon steel; nickel-titanium alloys, such as linear elastic and / or superelastic Nitinol; other nickel alloys, such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as Inconel 625, UNS: N06022, such as Hastelloy UNS: N10276, such as Hastelloy Other Hastelloy alloys, etc.), nickel-copper alloys (e.g., UNS: N04400, such as Monel 400, 400, 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as etc.), nickel-molybdenum alloys (e.g., UNS: N10665, such as Hastelloy ), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (for example, UNS: R30003, such as etc.); platinum-rich stainless steel; combinations thereof; or any other suitable material.

[0059] Examples of some suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, such as DuPont ), polyether block esters, polyurethanes, polypropylene (PP), polyvinyl chloride (PVC), polyether-esters (e.g., DSM Engineering Plastics ), ether or ester based copolymers (e.g., butylene / poly(alkylene ether) phthalate and / or other polyester elastomers such as DuPont ), polyamides (e.g., Bayer or Elf Atto Chemicals ), elastic polyamides, block polyamide / ethers, polyether block amides (PEBA, for example, sold under the trade name sold), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low-density polyethylene (e.g. ), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly(p-phenylene terephthalamide) (e.g., ), polysulfone, nylon, nylon-12 (for example, EMS American Grilon's ), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites thereof, etc.

[0060] It should be understood that the present disclosure is in many respects illustrative only. Changes may be made in detail, particularly in shape, size, and arrangement of steps, without exceeding the scope of the present disclosure. Where appropriate, this may include using any feature of an example embodiment for other embodiments. Of course, the scope of the present invention is limited by the language of the appended claims.

Claims

1. An implantable medical device adapted for implantation at an implantation site, capable of being implanted in more than one rotational orientation, comprising: an expandable body adapted to expand from a collapsed configuration for delivery to an expanded configuration for deployment; as well as A radiopaque indicator disposed relative to the expandable body is adapted to have a first appearance when viewed in a first rotational orientation and a second, different appearance when viewed in a second rotational orientation different from the first rotational orientation.

2. The implantable medical device of claim 1, wherein the radiopaque indicator is visible under fluoroscopy and is thus capable of indicating the position of the implantable medical device while it is still within a delivery device used to deliver it.

3. The implantable medical device of any one of claims 1 or 2, wherein the radiopaque indicator is visible under fluoroscopy and is thus capable of indicating the position of the implantable medical device after it has been at least partially deployed from a delivery device.

4. The implantable medical device of any one of claims 1 to 3, wherein the radiopaque indicator comprises a shape that mimics an alphanumeric character.

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

6. An implantable medical device according to claim 5, wherein the heart valve replacement includes a first layer of valve leaflet material and a second layer of valve leaflet material, and the radiopaque indicator is fixed to the first layer of valve leaflet material and / or the second layer of valve leaflet material.

7. An implantable medical device according to claim 6, wherein the radiopaque indicator is sutured to the first layer of valve leaflet material and / or the second layer of valve leaflet material.

8. The implantable medical device of claim 6, wherein the radiopaque indicator is disposed between the first layer of valve leaflet material and a second layer of valve leaflet material.

9. A heart valve replacement adapted for implantation into a native heart valve annulus, capable of being implanted in more than one rotational orientation, comprising: an expandable body adapted to expand from a collapsed configuration for delivery to an expanded configuration for deployment, the expandable body comprising a plurality of replacement valve commissure posts; valve material secured relative to the plurality of replacement valve commissure posts, the valve material forming a valve cusp between every two of the plurality of replacement valve commissure posts; as well as A radiopaque indicator is disposed relative to one of the plurality of replacement valve commissure posts, the radiopaque indicator being adapted to provide an indication of a rotational orientation of the heart valve replacement relative to a native heart valve annulus.

10. The heart valve replacement according to claim 9, wherein: The native heart valve comprises an aortic valve; The heart valve replacement comprises an aortic valve replacement; and The radiopaque indicator is adapted to provide an indication of a relative position of each of the plurality of commissure posts relative to a coronary artery proximate to a native aortic valve annulus.

11. A heart valve replacement according to any one of claims 9 or 10, wherein the radiopaque indicator is fixed relative to the valve material.

12. The heart valve replacement of any one of claims 9 to 11, wherein the radiopaque indicator is sutured to the valve material and / or one of the replacement valve commissure posts.

13. The heart valve replacement of any one of claims 9 to 12, wherein the radiopaque indicator comprises a shape that mimics an alphanumeric character when viewed from a position in front of the shape and appears as an asymmetric mirror image of the alphanumeric character when viewed from a position behind the shape.

14. An aortic valve replacement adapted for implantation into a native aortic valve having a plurality of native commissures, capable of being implanted in more than one rotational orientation, comprising: an expandable body adapted to expand from a collapsed configuration for delivery to an expanded configuration for deployment, the expandable body comprising a plurality of replacement valve commissure posts; a first layer of bovine valve material disposed on a first side of the plurality of replacement valve commissure posts; a second layer of bovine valve material disposed on a second side of the plurality of replacement valve commissure posts; and A radiopaque indicator is disposed between the first layer of bovine valve material and the second layer of bovine valve material, the radiopaque indicator being adapted to provide an indication of a rotational orientation of the aortic valve replacement relative to a native aortic valve.

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

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