News

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...

Researchers have announced the results of a clinical study that shows a key difference in the patient’s baseline heart size and function following transcatheter valve replacement (TAVR) that may...

FDA US device innovation

With recent medical device advances have come increasing concerns about the ability of the United States to remain at the forefront of research, especially in light of stringent FDA policies...

June 28, 2013 — Maquet Cardiovascular LLC announced it has acquired LAAx Inc., a privately held company that has developed a unique mechanical occlusion device called the TigerPaw System II....

Valtech Cardio Heart Valve Repair Cardioband Annuloplasty Ring

Valtech Cardio Ltd. announced that two patients diagnosed with severe mitral regurgitation (MR) have been treated successfully with its Transfemoral Cardioband Annuloplasty System.

Abbott has announced publication of positive outcomes from two European post-approval studies of the catheter-based MitraClip therapy for the treatment of mitral regurgitation (MR). Results...

Direct Flow Medical Inc. announced that it has received approval from the U.S. Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) to begin the SALUS feasibility...

June 3, 2013 — Medtronic Inc. announced it has received CE mark for valve-in-valve (VIV) procedures using the CoreValve and CoreValve Evolut transcatheter aortic valve implantation (TAVI) systems...

Cerebral function is the essence of quality of life. Its preservation throughout medical procedures is a key component to procedural success and patient care. New scientific data presented at the...

CardioKinetix Inc. announced the transmission of a live satellite feed of a clinical case using the catheter-based Parachute Device. The Parachute procedure was performed by Dr. Martyn Thomas...

The Lotus Valve, a second-generation transcatheter aortic valve implantation (TAVI) device, was successfully implanted in all of the first 60 patients in results from REPRISE II, which showed good...