News

JenaValve, TAVI system, heart valve repair, CE Mark, JenaValve CE Mark

JenaValve Technology, Inc. announced that it has raised $62.5 million in a Series C venture round.

aortic valve, Edwards Lifesciences, SAPIEN, SAPIEN aortic valve

Edwards announced a new post-hoc data analysis from The PARTNER Trial demonstrated that diabetic patients with aortic stenosis in need of heart valve replacement, but at high surgical risk,...

Lotus Valve System, heart valves, Boston Scientific Corporation

Boston Scientific reported favorable six-month results from the first 60 patients enrolled in the REPRISE II clinical trial evaluating the safety and performance of the Lotus Valve System in...

JenaValve, TAVI system, heart valve repair, CE Mark, JenaValve CE Mark

JenaValve Technology Inc. has received CE (Conformite Europeenne) mark approval from European regulators for its transapical TAVI system for the treatment of aortic insufficiency (AI), also known...

Edwards Lifesciences Medtronic Injunction Sapien XT Heart Valves Germany

The injunction against sales of Medtronic's transcatheter heart valves in Germany — issued in a July 12, 2013, court ruling — has gone into effect, according to Edwards Lifesciences Corp. The...

Vascular closure devices have a definite niche in areas where they were not originally intended but have found frequent off-label use because of their utility.

Direct Flow Medical Inc. announced the first patient enrollment in the U.S. SALUS clinical trial. The trial will study the Direct Flow Medical Transcatheter Aortic Heart Valve System,...

September 9, 2013 — Keystone Heart, a company in the development of cerebral protection devices for interventional cardiology and cardiac surgery procedures, announced its TriGuard cerebral...

Transcatheter aortic valve implantation (TAVI) is feasible in patients with bicuspid aortic valve (BV), according to research presented at European Society of Cardiology (ESC) Congress 2013 by Dr...

August 30, 2013 — PFM Medical received U.S. Food and Drug Administration (FDA) premarket approval (PMA) for its Nit-Occlud Patent Ductus Arteriosus (PDA) device, a permanently implanted prosthesis...

Edwards Lifesciences Corp. announced that Japan's Central Social Insurance Medical Council (Chuikyo) has approved the recommendation by the Japanese Ministry of Health, Labor and Welfare's (MHLW)...

JenaValve TAVI System Canada

JenaValve Technology Inc. has successfully completed the first two implantations of its second-generation transapical JenaValve transcatheter aortic valve implantation (TAVI) system in Canada....

August 22, 2013 – BioVentrix announced the successful first use of its Revivent Myocardial Anchoring System via the Less Invasive Ventricular Enhancement (LIVE) procedure in Germany. The...

Colibri Heart Valve LLC announced that enrollment its first-in-human feasibility study is continuing, and early clinical results from the second implantation of the Colibri device confirm the...

Gore Helex Septal Occluder Infringement Suit Ruiling AGA Medical Corp.

W. L. Gore & Associates announced a favorable ruling involving the Gore Helex Septal Occluder. The Hon. Judge Joan Ericksen of the U.S. District Court for the District of Minnesota ruled on...

Edwards Sapien 3 Transcatheter Aortic Hear Valve Clinical Trial

Edwards Lifesciences received conditional investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to initiate a clinical trial of its Edwards Sapien 3...

Thubrikar Aortic Valve’s Optimum TAV, transcatheter aortic valve implantation (TAVI) system, has surpassed 200 million cycles in an ongoing durability test — which simulates over five years in...

July 15, 2013 — Leonhardt Ventures and Core Manufacturing LLC have announced a new partnership to manufacture and bring to market a lineup of medical technologies.

Lariat Suture Device Left Atrial Appendage Occluder Stroke Risk

Shore University Medical Center is one of only a handful of hospitals in the country offering the recent U.S. Food and Drug Administration (FDA)-approved Lariat Suture Delivery Device procedure....

July 12, 2013 — A Chicago native living in southern California was the first patient at Scripps Health to receive a MitraClip as part of the clinical outcomes assessment of the MitraClip...