DE10301026A1 - Stent to be used for percutaneous insertion of artificial heart valve, comprising hook-shaped elements for exact positioning - Google Patents
Stent to be used for percutaneous insertion of artificial heart valve, comprising hook-shaped elements for exact positioning Download PDFInfo
- Publication number
- DE10301026A1 DE10301026A1 DE10301026A DE10301026A DE10301026A1 DE 10301026 A1 DE10301026 A1 DE 10301026A1 DE 10301026 A DE10301026 A DE 10301026A DE 10301026 A DE10301026 A DE 10301026A DE 10301026 A1 DE10301026 A1 DE 10301026A1
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- Germany
- Prior art keywords
- stent
- heart valve
- valve
- implantation
- exact positioning
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart 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
- A61F2/2412—Heart 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
- A61F2/2418—Scaffolds therefor, e.g. support stents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart 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
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/2436—Deployment by retracting a sheath
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0008—Fixation appliances for connecting prostheses to the body
- A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/0054—V-shaped
Landscapes
- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
Description
Gegenwärtiger Stand der Technik:Current state of the art:
Das derzeitige Standardverfahren zum Ersatz menschlicher Herzklappen verwendet gegenwärtig biologische oder mechanische Herzklappenprothesen, welche über eine operative Eröffnung des Brustkorbs nach Entfernung der kranken Herzklappe im Herzklappenbett festgenäht werden. Damit eine Herzklappe eingenäht werden kann, muß der Kreislauf des Patienten durch eine Herz-Lungen-Maschine getragen werden. Es wird ein Herzstillstand induziert und während des Herzstillstandes die Herzklappenprothese eingenäht. Es handelt sich folglich um einen sehr großen chirurgischen Eingriff mit entsprechenden Risiken für den Patienten und eine lange postoperative Behandlungsphase. Der Eingriff ist somit auf jüngere und möglichst gesunde Patienten beschränkt. Sehr alten Patienten und sehr herzschwachen Patienten kann dieser Eingriff nicht mehr zugemutet werden.The current standard procedure Biological valves are currently used to replace human heart valves or mechanical heart valve prostheses, which have an operative opening of the chest after removing the diseased heart valve, be sewn into the heart valve bed. So that a heart valve is sewn in can be, the Circulation of the patient carried by a heart-lung machine become. Cardiac arrest is induced and during the Cardiac arrest, the heart valve prosthesis is sewn on. It is consequently a very big one surgical intervention with corresponding risks for the patient and a long post-operative treatment period. The intervention is thus on younger ones and if possible healthy patients limited. Very old patients and very weak hearted patients can do this Intervention can no longer be expected.
Daher wurde in den letzten Jahren vermehrt nach Verfahren gesucht, welche die erkrankte Herzklappe mittels Katheter perkutan, transluminal ersetzen können. Zu diesem Verfahren, bei welchem eine Herzklappe mittels eines Stents durch einen Katheter am schlagenden herzen minimal-invasiv implantiert werden kann, sind mehrere nationale und internationale Patentente, Patentanmeldung und Gebrauchsmuster erteilt bzw. eingereicht auf die an dieser Stelle verwiesen wird.Therefore, in recent years increasingly searched for procedures that affect the diseased heart valve can be replaced percutaneously, transluminally using a catheter. To this method, in which a heart valve by means of a stent minimally invasively implanted through a catheter on the beating heart can be, several national and international patent ducks, patent application and utility model granted or filed to those referred to here becomes.
Grundlagen des transluminalen Herzklappenersatzes:Basics of transluminal Heart valve replacement:
Allen Verfahren des perkutanen, transluminalen Herzklappenersatzes gemeinsam ist das Vorbringen der zu implantierenden Herzklappenprothese mit einem Katheter, der über ein peripheres Gefäß minimal-invasiv, perkutan eingeführt wird. Die Klappenprothese ist in ein Träger-Stütz-System (Stent) eingebracht, welches aus einem Drahtgeflecht besteht und das bei der Implantation von selbst aufspringt (= selbstexpandierend) oder von einem Ballon aufgelehnt wird (= Ballon expandierbar). Unter Kontrolle von Röntgendurchleuchtung (Herzkatheterlabor = HKL) und Ultraschall (transösophageales Echokardiogramm = TEE) wird über einem Führungsdraht, der zuvor als Leitschiene platziert wurde, der Einführkatheter und die darin befindliche Herzklappen-Stent-Einheit zur Implantationsstelle vorgebracht, wo sich die erkrankte zu ersetzende Klappe befindet. Hier wird der Stent frei gegeben und durch die Stent-Expansion die neu Klappenprothese aufgespannt.All procedures of the percutaneous, transluminal Common heart valve replacement is the submission of the one to be implanted Heart valve prosthesis with a catheter that is minimally invasive via a peripheral vessel, introduced percutaneously becomes. The valve prosthesis is inserted into a carrier-support system (stent), which consists of a wire mesh and that during implantation jumps up by itself (= self-expanding) or from a balloon is rejected (= balloon expandable). Under X-ray control (Cardiac catheter laboratory = HKL) and ultrasound (transesophageal echocardiogram = TEE) is about a guide wire, which was previously placed as a guardrail, the insertion catheter and the heart valve stent unit located therein to the implantation site presented where the diseased valve to be replaced is located. Here, the stent is released and the stent expansion new prosthetic valve.
Nachleile des derzeitigen Verfahrens:Lag of the current procedure:
Als ein zwei wesentliche Nachteile des derzeitigen Verfahrens sind zum einen Probleme bei der sicheren Positionierung des Stents zu sehen, die trotz hoher Auflösung im HKL und des TEE die Gefahr- von Fehlimplantationen birgt. Eine Implantation des Herzklappen-Stents zu weit in der Herzkammer (Ventrikel) führt zur Undichtigkeit (Klappeninsuffizienz) und erheblichen Belastung des Ventrikels. Eine Fehlimplantation zu weit oberhalb der eigentlichen Klappenebene kann zum Verschluss der Abgänge der Herzkranzgefäße (Koronarien) und damit zu einer tödlichen Koronarischämie mit Herzinfarkt führen.As one of two major drawbacks On the one hand, the current procedure presents problems with the safe Positioning of the stent can be seen, which despite the high resolution in the HKL and the TEE harbors the risk of incorrect implantations. An implantation of the Heart valve stents too far in the heart chamber (ventricle) leads to Leakage (valve insufficiency) and considerable stress on the Ventricle. An incorrect implantation too far above the actual valve level can close the outlets of the Coronary arteries and thus a deadly coronary ischemia lead with heart attack.
Des Weiteren muss eine Aortenklappenprothese erhebliche Kräfte während der Diastole aushalten, die eine sichere Verankerung des Herzklappen-Stents voraussetzt, damit dieser nicht in den Ventrikel disloziert. Eine solche Verankerung bieten Widerhaken, welche sich in der Wand der Aorta abstutzen, wie dies in dem deutschen Patent Nr. 195 466 92 dargestellt ist. Eine zusätzliche Veraukerung oder Abstützung wäre jedoch aus Sicherheitsgründen hier wünschenswert.Furthermore, an aortic valve prosthesis considerable forces while endure the diastole, which securely anchors the heart valve stent assumes that it does not dislocate into the ventricle. A such anchoring offers barbs, which are in the wall of the Trim the aorta, as described in German Patent No. 195 466 92 is shown. An additional Sale or support would be however for safety reasons desirable here.
Darstellung der Erfindungpresentation the invention
Der im Patentanspruch angegebenen Erfindung liegen die o.g. Probleme bei der transluminalen Herzklappenimplantation zugrunde, dass Bedarf für die Weiterentwicklung dieses Verfahrens eine sicher Positionierung bei der Implantation und eine zusätzliche Abstützung des Herzklappen-Stents gegen eine ventrikelwärts gerichtete Dislokation besteht.The specified in the claim Invention lie the above. Problems with transluminal heart valve implantation underlying that need for the Further development of this method ensures a safe positioning the implantation and an additional support of the heart valve stent against a ventricular dislocation consists.
Dazu wurde eine Modifikation der
derzeitig verfügbaren
Stents hinsichtlich der Bauart und damit des Verhaltens bei Implantation
und hinsichtlich der Verankerung vorgenommen. Diese Modifikation
sieht Bügel
/ Streben bzw. Ausarbeitungen des Stents vor, welche bei der Implantation
in die Taschen der alten Klappe hinein geschoben werden (
Die Bügel / Streben / Ausarbeitungen des Stents gewährleisten somit während der Implantation eine sichere Positionierung durch die anatomischen Strukturen der Taschen der alten Klappe, die neben der Kontrolle im HKL und mittels TEE die exakte Implantation des Herzklappen-Stents erlaubt. Außerdem gewährleistet dieses Konstruktionsmerkmal eine zusätzliche Abstützung in den Taschen und damit am Klappenring der alten Herzklappe, wodurch eine Dislokation des Herzklappen-Stents in Richtung der linken Herzkammer verhindert wird.The stirrups / struts / elaborations ensure the stent thus during the implantation ensures safe positioning through the anatomical structures the pockets of the old flap that are next to the control in the HVAC and allows the exact implantation of the heart valve stent using TEE. In addition guaranteed this design feature an additional support in the pockets and thus on the valve ring of the old heart valve, which creates a Dislocation of the heart valve stent towards the left ventricle is prevented.
Diese Konstruktionsmerkmale des Stents bieten die gleichen Vorzüge auch bei transluminalen Ersatz der Pulmonalklappe. Somit soll das o. g. Verfahren und die beschriebenen Konstruktionsmerkmale des Herzklappen-Stents in Analogie für den Einsatz an der rechten Herzkammer (rechter Ventrikel, Pulmonalklappe, Arteria pulmonalis) gelten.These stent design features provide the same benefits also with transluminal replacement of the pulmonary valve. So that should o. g. Process and the described design features of the Heart valve stents in analogy for use on the right ventricle (right ventricle, pulmonary valve, Pulmonary artery) apply.
Gegenüber den bisherigen Herzklappenprothesen für einen transluminalen Klappenersatz zeichnet sich die Erfindung dadurch aus:
- 1. Daß der Herzklappen-Stent um Bügel / Streben / Ausarbeitungen ergänzt wird.
- 2. Daß diese Bügel / Streben / Ausarbeitungen während der ersten Phase der Implantation aus dem Katheter im Bereich der Hauptschlagader (Aortenwiirzel) bzw. im proximalen Anteil der Lungenschlagader (Arteria pulmonalis) freigegeben werden.
- 3. Daß diese Bügel / Streben / Ausarbeitungen während der Implantation in die Taschen der alten Herzklappe hinein geschoben werden.
- 4. Daß die Bügel / Streben / Ausarbeitungen eine exaktere Implantation des Herzklappen-Stents ermöglichen.
- 5. Daß durch diese Modifikation der Bauart des Herzklappen-Stents eine zusätzliche Verankerung des Systems gegen eine Dislokation ermöglicht..
- 6. Daß diese Modifikation der Bauart des Herzklappen-Stents beim transluminalen Ersatz der Aorten- wie auch der Pulinonalklappe Verwendung finden kann.
- 1. That the heart valve stent is supplemented by stirrups / struts / elaborations.
- 2. That these stirrups / struts / elaborations are released from the catheter in the area of the main artery (aortic root) or in the proximal part of the pulmonary artery (pulmonary artery) during the first phase of implantation.
- 3. That these stirrups / struts / elaborations are pushed into the pockets of the old heart valve during implantation.
- 4. That the stirrups / struts / elaborations enable a more precise implantation of the heart valve stent.
- 5. That this modification of the design of the heart valve stent enables additional anchoring of the system against dislocation.
- 6. That this modification of the design of the heart valve stent can be used in the transluminal replacement of the aortic as well as the pulinonal valve.
Ausführungsbeispiele der Erfindung
sind in den
Claims (5)
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE10301026.2A DE10301026B4 (en) | 2002-08-13 | 2003-01-14 | Device for anchoring and aligning heart valve prostheses |
DE20321838U DE20321838U1 (en) | 2002-08-13 | 2003-01-14 | Device for anchoring and aligning heart valve prostheses |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE10237573 | 2002-08-13 | ||
DE10237573.9 | 2002-08-13 | ||
DE10301026.2A DE10301026B4 (en) | 2002-08-13 | 2003-01-14 | Device for anchoring and aligning heart valve prostheses |
Publications (2)
Publication Number | Publication Date |
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DE10301026A1 true DE10301026A1 (en) | 2004-02-26 |
DE10301026B4 DE10301026B4 (en) | 2014-10-30 |
Family
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DE10301026.2A Expired - Lifetime DE10301026B4 (en) | 2002-08-13 | 2003-01-14 | Device for anchoring and aligning heart valve prostheses |
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Cited By (38)
Publication number | Priority date | Publication date | Assignee | Title |
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WO2007048529A1 (en) * | 2005-10-28 | 2007-05-03 | Jenavalve Technology Inc. | Device for implanting and fastening heart valve prostheses |
EP2201911A3 (en) * | 2008-12-23 | 2010-11-17 | Sorin Biomedica Cardio S.r.l. | Expandable prosthetic valve having anchoring appendages |
US7896915B2 (en) | 2007-04-13 | 2011-03-01 | Jenavalve Technology, Inc. | Medical device for treating a heart valve insufficiency |
US8062355B2 (en) | 2005-11-04 | 2011-11-22 | Jenavalve Technology, Inc. | Self-expandable medical instrument for treating defects in a patient's heart |
US8109996B2 (en) | 2004-03-03 | 2012-02-07 | Sorin Biomedica Cardio, S.R.L. | Minimally-invasive cardiac-valve prosthesis |
US8317858B2 (en) | 2008-02-26 | 2012-11-27 | Jenavalve Technology, Inc. | Stent for the positioning and anchoring of a valvular prosthesis in an implantation site in the heart of a patient |
US8398704B2 (en) | 2008-02-26 | 2013-03-19 | Jenavalve Technology, Inc. | Stent for the positioning and anchoring of a valvular prosthesis in an implantation site in the heart of a patient |
US8465540B2 (en) | 2008-02-26 | 2013-06-18 | Jenavalve Technology, Inc. | Stent for the positioning and anchoring of a valvular prosthesis |
US8468667B2 (en) | 2009-05-15 | 2013-06-25 | Jenavalve Technology, Inc. | Device for compressing a stent |
US8512397B2 (en) | 2009-04-27 | 2013-08-20 | Sorin Group Italia S.R.L. | Prosthetic vascular conduit |
US8539662B2 (en) | 2005-02-10 | 2013-09-24 | Sorin Group Italia S.R.L. | Cardiac-valve prosthesis |
US8679174B2 (en) | 2005-01-20 | 2014-03-25 | JenaValve Technology, GmbH | Catheter for the transvascular implantation of prosthetic heart valves |
US8685084B2 (en) | 2011-12-29 | 2014-04-01 | Sorin Group Italia S.R.L. | Prosthetic vascular conduit and assembly method |
US8808369B2 (en) | 2009-10-05 | 2014-08-19 | Mayo Foundation For Medical Education And Research | Minimally invasive aortic valve replacement |
US8840661B2 (en) | 2008-05-16 | 2014-09-23 | Sorin Group Italia S.R.L. | Atraumatic prosthetic heart valve prosthesis |
US9044318B2 (en) | 2008-02-26 | 2015-06-02 | Jenavalve Technology Gmbh | Stent for the positioning and anchoring of a valvular prosthesis |
US9138315B2 (en) | 2007-04-13 | 2015-09-22 | Jenavalve Technology Gmbh | Medical device for treating a heart valve insufficiency or stenosis |
US9161836B2 (en) | 2011-02-14 | 2015-10-20 | Sorin Group Italia S.R.L. | Sutureless anchoring device for cardiac valve prostheses |
US9168130B2 (en) | 2008-02-26 | 2015-10-27 | Jenavalve Technology Gmbh | Stent for the positioning and anchoring of a valvular prosthesis in an implantation site in the heart of a patient |
US9248017B2 (en) | 2010-05-21 | 2016-02-02 | Sorin Group Italia S.R.L. | Support device for valve prostheses and corresponding kit |
US9289289B2 (en) | 2011-02-14 | 2016-03-22 | Sorin Group Italia S.R.L. | Sutureless anchoring device for cardiac valve prostheses |
US9295551B2 (en) | 2007-04-13 | 2016-03-29 | Jenavalve Technology Gmbh | Methods of implanting an endoprosthesis |
US9510947B2 (en) | 2011-10-21 | 2016-12-06 | Jenavalve Technology, Inc. | Catheter system for introducing an expandable heart valve stent into the body of a patient |
US9597182B2 (en) | 2010-05-20 | 2017-03-21 | Jenavalve Technology Inc. | Catheter system for introducing an expandable stent into the body of a patient |
US9744031B2 (en) | 2010-05-25 | 2017-08-29 | Jenavalve Technology, Inc. | Prosthetic heart valve and endoprosthesis comprising a prosthetic heart valve and a stent |
US9848981B2 (en) | 2007-10-12 | 2017-12-26 | Mayo Foundation For Medical Education And Research | Expandable valve prosthesis with sealing mechanism |
US9867694B2 (en) | 2013-08-30 | 2018-01-16 | Jenavalve Technology Inc. | Radially collapsible frame for a prosthetic valve and method for manufacturing such a frame |
US9867699B2 (en) | 2008-02-26 | 2018-01-16 | Jenavalve Technology, Inc. | Endoprosthesis for implantation in the heart of a patient |
US9878127B2 (en) | 2012-05-16 | 2018-01-30 | Jenavalve Technology, Inc. | Catheter delivery system for heart valve prosthesis |
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DE19546692C2 (en) * | 1995-12-14 | 2002-11-07 | Hans-Reiner Figulla | Self-expanding heart valve prosthesis for implantation in the human body via a catheter system |
US5855601A (en) * | 1996-06-21 | 1999-01-05 | The Trustees Of Columbia University In The City Of New York | Artificial heart valve and method and device for implanting the same |
US6458153B1 (en) * | 1999-12-31 | 2002-10-01 | Abps Venture One, Ltd. | Endoluminal cardiac and venous valve prostheses and methods of manufacture and delivery thereof |
FR2828263B1 (en) * | 2001-08-03 | 2007-05-11 | Philipp Bonhoeffer | DEVICE FOR IMPLANTATION OF AN IMPLANT AND METHOD FOR IMPLANTATION OF THE DEVICE |
-
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- 2003-01-14 DE DE10301026.2A patent/DE10301026B4/en not_active Expired - Lifetime
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US8109996B2 (en) | 2004-03-03 | 2012-02-07 | Sorin Biomedica Cardio, S.R.L. | Minimally-invasive cardiac-valve prosthesis |
US9867695B2 (en) | 2004-03-03 | 2018-01-16 | Sorin Group Italia S.R.L. | Minimally-invasive cardiac-valve prosthesis |
US8535373B2 (en) | 2004-03-03 | 2013-09-17 | Sorin Group Italia S.R.L. | Minimally-invasive cardiac-valve prosthesis |
US9788945B2 (en) | 2005-01-20 | 2017-10-17 | Jenavalve Technology, Inc. | Systems for implanting an endoprosthesis |
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