WO2006004679B1 - Prosthetic cardiac valve and method for making same - Google Patents

Prosthetic cardiac valve and method for making same

Info

Publication number
WO2006004679B1
WO2006004679B1 PCT/US2005/022775 US2005022775W WO2006004679B1 WO 2006004679 B1 WO2006004679 B1 WO 2006004679B1 US 2005022775 W US2005022775 W US 2005022775W WO 2006004679 B1 WO2006004679 B1 WO 2006004679B1
Authority
WO
WIPO (PCT)
Prior art keywords
layer
stent
biological material
prosthetic valve
valve
Prior art date
Application number
PCT/US2005/022775
Other languages
French (fr)
Other versions
WO2006004679A1 (en
Inventor
Timur Paul Sarac
Nicholas G Smedira
Original Assignee
Cleveland Clinic Foundation
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US10/880,277 external-priority patent/US7377938B2/en
Application filed by Cleveland Clinic Foundation filed Critical Cleveland Clinic Foundation
Priority to AU2005260008A priority Critical patent/AU2005260008B2/en
Priority to EP05767754A priority patent/EP1773251A1/en
Publication of WO2006004679A1 publication Critical patent/WO2006004679A1/en
Publication of WO2006004679B1 publication Critical patent/WO2006004679B1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2415Manufacturing methods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418Scaffolds therefor, e.g. support stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2475Venous valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008Fixation appliances for connecting prostheses to the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008Fixation appliances for connecting prostheses to the body
    • A61F2220/0016Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028Shapes in the form of latin or greek characters
    • A61F2230/0054V-shaped
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0073Quadric-shaped
    • A61F2230/008Quadric-shaped paraboloidal

Abstract

A prosthetic valve for replacing a cardiac valve (202) includes an expandable support member (250) and at least two valve leaflets (204) made of a first layer of biological material (208) selected from peritoneal tissue, pleural tissue or pericardial tissue. A second layer (14a) of biological material is attached to the support member. The second layer is also made from peritoneal tissue, pleural tissue or pericardial tissue. The second layer includes a radially inwardly facing surface that defines a conduit for directing blood flow. The valve leaflets extend across the conduit to permit unidirectional flow of blood through the conduit. Methods for making and implanting the prosthetic valve are also provided.

Claims

AMENDED CLAIMS
[received by the International Bureau on 20 December 2005 (20.12.2005); original claims 1-13, 15, 17-23, 46-59 amended, claims 14, 16, 24-45 cancelled]
1. A prosthetic valve (202) for replacing a cardiac valve, said prosthetic valve (202) comprising: an expandable support member (250); at least two valve leaflets (204, 206) made of a first layer of biological material (208) selected from a group consisting of peritoneal tissue, pleural tissue and pericardial tissue; a second layer of biological material (14a) attached to said support member (250), said second layer (14a) being selected from a group consisting of peritoneal tissue, pleural tissue and pericardial tissue; said second layer (14a) including a radially inwardly facing surface (48) that defines a conduit for directing blood flow; and said at least two valve leaflets (204, 206) extending across said conduit to permit unidirectional flow of blood through said conduit.
2. The prosthetic valve (202) of claim 1 wherein said support member (250) comprises a stent (250) having inner and outer surfaces (264, 262), said second layer (14a) being attached to said inner surface (264).
3. The prosthetic valve (202) of claim 2 wherein said support [means] member (250) further comprises a strut member (240) located at each of at least two commissural sides (230, 232) formed by the junctions of adjoining portions (224, 226) of said at least two valve leaflets (204, 206).
4. The prosthetic valve (202) of claim 2 wherein said second layer (14a) extends along a portion of the length of said stent (250) to form an enclosed section of said stent (250) that is lined with said second layer (14a) and at least one bare section of said stent (250) that is not lined with said second layer (14a). 5. The prosthetic valve (202) of claim 2 wherein said stent (250) has oppositely disposed proximal and distal end sections (256, 258) and a center section (260) disposed between said end sections (256, 258), said at least two valve leaflets (204, 206) extending within said center section (260).
6. The prosthetic valve (202) of claim 5 wherein said second layer (14a) extends along said center section (260) of said stent (250).
7. The prosthetic valve (202) of claim 6 wherein said second layer (14a) includes at least two radial openings (290) in said center section (260).
8. The prosthetic valve (202) of claim 6 wherein said second layer (14a) further extends along said proximal end section (256) of said stent (250).
9. The prosthetic valve (202) of claim 6 wherein said proximal and distal end sections (256, 258) of said stent (250) are bare and said center section (260) of said stent (250) is lined with said second layer (14a).
10. The prosthetic valve (202) of claim 5 wherein said second layer (14a) extends along said proximal end section (256) of said stent (250).
11. The prosthetic valve (202) of claim 5 wherein said center section (260) of said stent (250) has a convex shape in the axial direction for conforming to the shape of the cardiac wall downstream of the cardiac valve.
12. The prosthetic valve (202) of claim 11 wherein said distal end section (258) of said stent (250) has a concave shape in the axial direction for conforming to the shape of the cardiac wall downstream of the cardiac valve. 13. The prosthetic valve (202) of claim 5 wherein said distal end section (258) of said stent (250) has a concave shape in the axial direction for conforming to the shape of the cardiac wall downstream of the cardiac valve.
14. (Canceled.)
15. The prosthetic valve (202) of claim 14 wherein at least one of said proximal, distal, and center sections (256, 258, 260) of said stent (250) is self- expanding.
16. (Canceled.)
17. The prosthetic valve (202) of claim 1 wherein said second layer of biological material (14a) comprises a serous membrane.
18. The prosthetic valve (202) of claim 17 wherein said first layer of biological material (208) comprises a serous membrane.
19. The prosthetic valve (202) of claim 17 wherein said first layer of biological material (208) comprises an inner lining (210) of a serous membrane and an outer lining (212) of fascia.
20. The prosthetic valve (202) of claim 1 wherein said first layer of biological material (208) comprises an inner lining (210) of a serous membrane and an outer lining (212) of fascia.
21. The prosthetic valve (202) of claim 1 wherein said first layer of biological material (208) comprises a serous membrane. 22. The prosthetic valve (202) of claim 1 wherein each of said at least two valve leaflets (204, 206) has an oppositely disposed pair of lateral sides (224, 226) spaced apart by a free edge (222), said lateral sides (224, 226) of each of said at least two valve leaflets (204, 206) adjoining each other and being attached to each other to form at least two commissural sides (230, 232) that are separated by said free edges (222), said free edges (222) being coaptable to permit unidirectional flow of blood through said conduit.
23. The prosthetic valve (202) of claim 22 wherein said support [means] member (250) comprises at least one strut member (240) positioned at each of said commissural sides (230, 232) formed at the junction of said lateral sides (224, 226) of said at least two valve leaflets (204, 206).
24-45. (Canceled.)
46. A method for producing a prosthetic valve (202), said method comprising the steps of: harvesting a first layer of biological material (208) comprising a single sheet of material (208) selected from a group consisting of peritoneal tissue, pleural tissue and pericardial tissue; trimming the sheet of biological material (208) to form at least two valve leaflets (204, 206), each of the at least two valve leaflets (204, 206) having an oppositely disposed pair of lateral sides (224, 226) spaced apart by a free edge (222); placing the lateral sides (224, 226) of each of the at least two valve leaflets (204, 206) adjacent each other and attaching them (224, 226) to each other to form an oppositely disposed pair of commissural sides (230, 232) separated by the free edges (222) that are coaptable to permit unidirectional flow of blood; attaching support means to the sheet of biological material (208) to provide structural support for the at least two valve leaflets (204, 206), the support means comprising an expandable stent (250); harvesting a second layer of biological material (14a) selected from a group consisting of peritoneal tissue, pleural tissue and pericardial tissue; and attaching the second layer of biological material (14a) to an inner surface (264) of the stent (250).
47. The method of claim 46 wherein the support means further comprises at least two strut members (240), said method further comprising the step of positioning one of the at least two strut members (240) at each of the at least two commissural sides (230, 232).
48. The method of claim 46 wherein the second layer of biological material (14a) includes a radially inwardly facing surface (48) that defines a conduit for directing blood flow, said method further comprising the step of attaching the at least two valve leaflets (204, 206) to the stent (250) and the second layer of biological material (14a) so that the at least two valve leaflets (204, 206) extend across the conduit.
49. The method of claim 46 wherein said step of harvesting the second layer of biological material (14a) comprises harvesting a serous membrane of peritoneal, pleural or pericardial tissue.
50. The method of claim 49 wherein said step of harvesting the first layer of biological material (208) comprises harvesting a serous membrane of peritoneal, pleural or pericardial tissue.
51. The method of claim 49 wherein said step of harvesting the first layer of biological material (208) comprises harvesting an inner lining (210) of serous membrane and an outer lining (212) of fascia.
52. The method of claim 46 wherein said step of harvesting the first layer of biological material (208) comprises harvesting an inner lining (210) of serous membrane and an outer lining (212) of fascia. 53. The method of claim 46 wherein said step of harvesting the first layer of biological material (208) comprises harvesting a serous membrane of peritoneal, pleural or pericardial tissue.
54. The method of claim 46 wherein said step of attaching the second layer of biological material (14a) to the inner surface (264) of the stent (250) comprises attaching the second layer (14a) along a portion of the length of the stent (250) to form a first section of said stent (250) that is lined with the second layer (14a) and a second section of the stent (250) that is bare.
55. The method of claim 46 wherein the stent (250) has oppositely disposed proximal and distal end sections (256, 258) and a center section (260) disposed between the end sections (256, 258), said step of attaching the sheet of biological material to the stent (250) comprises attaching the at least two valve leaflets (204, 206) to the center section (260) of the stent (250).
56. The method of claim 55 wherein said step of attaching the second layer of biological material (14a) to the inner surface (264) of the stent (250) includes the step of attaching the second layer (14a) along the inner surface (264) in the center section (260) of the stent (250).
57. The method of claim 56 further comprising the step of forming at least two radial openings (290) in the second layer (14a) in the center section (260).
58. The method of claim 56 wherein said step of attaching the second layer of biological material (14a) to the inner surface (264) of the stent (250) includes the step of attaching the second layer (14a) along the imier surface (264) in the proximal end section (256) of the stent (250). 59. The method of claim 55 wherein said step of attaching the second layer of biological material (14a) to the inner surface (264) of the stent (250) includes the step of attaching the second layer (14a) along the inner surface (264) in the proximal end section (256) of the stent (250).
60-68. (Canceled.)
PCT/US2005/022775 2004-06-29 2005-06-25 Prosthetic cardiac valve and method for making same WO2006004679A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU2005260008A AU2005260008B2 (en) 2004-06-29 2005-06-25 Prosthetic cardiac valve and method for making same
EP05767754A EP1773251A1 (en) 2004-06-29 2005-06-25 Prosthetic cardiac valve and method for making same

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US10/880,277 2004-06-29
US10/880,277 US7377938B2 (en) 2001-07-19 2004-06-29 Prosthetic cardiac value and method for making same

Publications (2)

Publication Number Publication Date
WO2006004679A1 WO2006004679A1 (en) 2006-01-12
WO2006004679B1 true WO2006004679B1 (en) 2006-03-09

Family

ID=34993140

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2005/022775 WO2006004679A1 (en) 2004-06-29 2005-06-25 Prosthetic cardiac valve and method for making same

Country Status (3)

Country Link
EP (1) EP1773251A1 (en)
AU (1) AU2005260008B2 (en)
WO (1) WO2006004679A1 (en)

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8721717B2 (en) 2003-12-19 2014-05-13 Boston Scientific Scimed, Inc. Venous valve apparatus, system, and method
US8932349B2 (en) 2004-09-02 2015-01-13 Boston Scientific Scimed, Inc. Cardiac valve, system, and method
US9168122B2 (en) 2012-04-26 2015-10-27 Rex Medical, L.P. Vascular device and method for valve leaflet apposition
US9301843B2 (en) 2003-12-19 2016-04-05 Boston Scientific Scimed, Inc. Venous valve apparatus, system, and method
US9331328B2 (en) 2006-03-28 2016-05-03 Medtronic, Inc. Prosthetic cardiac valve from pericardium material and methods of making same
US9370419B2 (en) 2005-02-23 2016-06-21 Boston Scientific Scimed, Inc. Valve apparatus, system and method
US9421083B2 (en) 2007-02-05 2016-08-23 Boston Scientific Scimed Inc. Percutaneous valve, system and method

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US6676698B2 (en) 2000-06-26 2004-01-13 Rex Medicol, L.P. Vascular device with valve for approximating vessel wall
US20060173490A1 (en) 2005-02-01 2006-08-03 Boston Scientific Scimed, Inc. Filter system and method
US7722666B2 (en) 2005-04-15 2010-05-25 Boston Scientific Scimed, Inc. Valve apparatus, system and method
US8012198B2 (en) 2005-06-10 2011-09-06 Boston Scientific Scimed, Inc. Venous valve, system, and method
US7569071B2 (en) 2005-09-21 2009-08-04 Boston Scientific Scimed, Inc. Venous valve, system, and method with sinus pocket
EP3400908B1 (en) * 2006-05-30 2020-06-17 Cook Medical Technologies LLC Artificial valve prosthesis
WO2008091493A1 (en) 2007-01-08 2008-07-31 California Institute Of Technology In-situ formation of a valve
US8834551B2 (en) * 2007-08-31 2014-09-16 Rex Medical, L.P. Vascular device with valve for approximating vessel wall
US7892276B2 (en) 2007-12-21 2011-02-22 Boston Scientific Scimed, Inc. Valve with delayed leaflet deployment
US9668859B2 (en) 2011-08-05 2017-06-06 California Institute Of Technology Percutaneous heart valve delivery systems
US9427303B2 (en) 2012-04-27 2016-08-30 Cook Medical Technologies Llc Anti-aspiration valve
US9314325B2 (en) 2012-04-27 2016-04-19 Cook Medical Technologies Llc Anti-aspiration prosthesis
EP2841020B1 (en) * 2012-04-27 2017-07-26 Cook Medical Technologies LLC Anti-aspiration prosthesis
US9585748B2 (en) * 2012-09-25 2017-03-07 Edwards Lifesciences Corporation Methods for replacing a native heart valve and aorta with a prosthetic heart valve and conduit
WO2014066081A1 (en) 2012-10-24 2014-05-01 Cook Medical Technologies Llc Anti-reflux prosthesis
EP2752170B1 (en) 2013-01-08 2017-02-22 Cook Medical Technologies LLC Multi valve anti-reflux prosthesis
US9744037B2 (en) 2013-03-15 2017-08-29 California Institute Of Technology Handle mechanism and functionality for repositioning and retrieval of transcatheter heart valves
WO2015048435A1 (en) * 2013-09-26 2015-04-02 Cvdevices, Llc Devices, systems, and methods to precondition, arterialize and/or occlude a mammalian luminal organ
US9668861B2 (en) 2014-03-15 2017-06-06 Rex Medical, L.P. Vascular device for treating venous valve insufficiency
US20190069996A1 (en) * 2017-09-07 2019-03-07 Edwards Lifesciences Corporation Integral flushing solution for blood stasis prevention in artificial heart valves

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US7195641B2 (en) * 1999-11-19 2007-03-27 Advanced Bio Prosthetic Surfaces, Ltd. Valvular prostheses having metal or pseudometallic construction and methods of manufacture
US6579307B2 (en) * 2001-07-19 2003-06-17 The Cleveland Clinic Foundation Endovascular prosthesis having a layer of biological tissue
US7351256B2 (en) * 2002-05-10 2008-04-01 Cordis Corporation Frame based unidirectional flow prosthetic implant

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8721717B2 (en) 2003-12-19 2014-05-13 Boston Scientific Scimed, Inc. Venous valve apparatus, system, and method
US9301843B2 (en) 2003-12-19 2016-04-05 Boston Scientific Scimed, Inc. Venous valve apparatus, system, and method
US8932349B2 (en) 2004-09-02 2015-01-13 Boston Scientific Scimed, Inc. Cardiac valve, system, and method
US9370419B2 (en) 2005-02-23 2016-06-21 Boston Scientific Scimed, Inc. Valve apparatus, system and method
US9331328B2 (en) 2006-03-28 2016-05-03 Medtronic, Inc. Prosthetic cardiac valve from pericardium material and methods of making same
US9421083B2 (en) 2007-02-05 2016-08-23 Boston Scientific Scimed Inc. Percutaneous valve, system and method
US9168122B2 (en) 2012-04-26 2015-10-27 Rex Medical, L.P. Vascular device and method for valve leaflet apposition

Also Published As

Publication number Publication date
WO2006004679A1 (en) 2006-01-12
AU2005260008A1 (en) 2006-01-12
AU2005260008B2 (en) 2009-07-16
EP1773251A1 (en) 2007-04-18

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