Aortic Stenosis News and Research

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El Camino announces first patient implant in Medtronic CoreValve clinical trial

El Camino Hospital today announced its first patient implant in the Medtronic CoreValve® U.S. Clinical Trial.

22 Dec 2010

Boston Scientific signs definitive agreement to acquire Sadra Medical

Boston Scientific Corporation today announced the signing of a definitive merger agreement, under which Boston Scientific will acquire Sadra Medical, Inc., a development-stage company in Los Gatos, California. Sadra is developing the first fully repositionable device for percutaneous aortic valve replacement to treat patients with severe aortic stenosis.

20 Nov 2010

Medtronic CoreValve System IDE for transcatheter aortic valve implantation receives FDA approval

Medtronic, Inc. today announced U.S. Food and Drug Administration (FDA) conditional approval for its Investigational Device Exemption (IDE) application and pivotal clinical trial protocol to begin evaluating the Medtronic CoreValve System for transcatheter aortic valve implantation (TAVI).

15 Oct 2010

Cedars-Sinai physicians to lead St. Jude Medical's transcatheter aortic valve implantation clinical trial

St. Jude Medical, Inc., a global medical device company, today announced that physicians from the Cedars-Sinai Heart Institute will lead the company's transcatheter aortic valve implantation (TAVI) clinical trial. The study will evaluate the safety and efficacy of the St. Jude Medical transcatheter aortic valve for patients who experience severe aortic stenosis and who may be at an elevated risk for open-heart surgery.

29 Sep 2010

Ready-to-Use Cardene I.V. lowers acutely elevated blood pressure: CLUE study

Results from the CLUE study, a head-to-head comparison between Ready-to-Use Cardene I.V. (nicardipine) and labetalol in the emergency room, showed that Ready-to-Use Cardene I.V. lowers acutely elevated blood pressure more effectively than labetalol. These data were presented today at the annual meeting of the American College of Emergency Physicians (ACEP) in Las Vegas, Nevada.

29 Sep 2010

Early recipient of transcatheter aortic valve receives Courageous Patient Award

Lillian Feldshuh, of Scarsdale, NY, an early recipient of a transcatheter aortic valve in 2006, received the Courageous Patient Award yesterday at the Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC. The procedure was a success and Feldshuh, who will turn 100 years in just 7 months, remains in good health.

27 Sep 2010

TAVI procedure reduces mortality rate in patients with aortic stenosis

Just released data from a clinical trial shows promise for a new minimally invasive treatment option for patients with severe aortic stenosis who are too sick for traditional forms of open-heart surgery. As compared to standard medical therapy, the new procedure, transcatheter aortic valve implantation (TAVI), significantly reduced mortality rates in patients who received the new valve.

24 Sep 2010

TAVI procedure effective in patients unsuitable for surgical valve replacement: Study

One-year data from the PARTNER clinical trial, published today in the New England Journal of Medicine, demonstrate that transcatheter aortic-valve implantation, compared with standard therapy, resulted in significantly lower rates of death among patients who cannot undergo surgery for aortic stenosis. The results will be presented tomorrow as a Late Breaking Trial at the 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.

23 Sep 2010

Implantation of new bioprosthetic-tissue valve in patients with severe aortic stenosis saves lives

Implantation of a new bioprosthetic-tissue valve into the hearts of patients who have severe aortic stenosis and are too sick or too old for open-heart surgery has been found to both save lives and improve the quality of those lives, according to a new multicenter study, to be published online at 2 p.m. Pacific time today in the New England Journal of Medicine.

23 Sep 2010

Enlarged hearts regress faster in elderly women than in men after aortic valve replacement

Heart enlargement caused by narrowed aortic valves regresses faster in elderly women than in men after aortic valve replacement, according to research reported in a surgical supplement of Circulation: Journal of the American Heart Association.

14 Sep 2010

Late breaking clinical trials in interventional cardiovascular medicine to be presented at TCT 2010

Clinical trials in a variety of areas within interventional cardiovascular medicine that will be presented at TCT 2010 will directly affect the way that people with cardiovascular disease are treated. Breakthroughs in science and medical research, presented exclusively at TCT, will lead to new treatments that are minimally invasive and involve shorter recovery times. Among the topics being covered are stenting in the femoral artery, polymer-free drug-eluting stents, valves and drug-eluting balloons used in angioplasty.

8 Sep 2010

BRINAVESS IV granted marketing approval in EU for conversion of recent onset AF to sinus rhythm

MSD and Cardiome Pharma Corp. today announced that the intravenous (IV) formulation of BRINAVESS™ (vernakalant) has been granted marketing approval in the European Union (EU), Iceland and Norway for the conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults.

2 Sep 2010

EMA CHMP recommends marketing approval of BRINAVESS for conversion of recent onset AF to sinus rhythm

Merck and Cardiome Pharma Corp. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing approval for BRINAVESS® (vernakalant), an investigational intravenous (IV) formulation for the conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults.

28 Jun 2010

New clinical data for CoreValve transcatheter aortic valve replacement system presented at EuroPCR

New clinical data presented today at EuroPCR demonstrate positive long-term performance and durability for the CoreValve transcatheter aortic valve replacement system from Medtronic, Inc. Two-year results from the pivotal 18-French CoreValve multicenter prospective study provide important additional evidence supporting wider use of the world's market-leading transcatheter aortic valve.

26 May 2010

Medtronic to appeal U.S. jury verdict in CoreValve system patent infringement case

Medtronic, Inc., announced today that it will appeal the $73.5 million jury verdict returned in the U.S. District Court in Delaware deciding that the CoreValve® transcatheter aortic valve system infringes a valid U.S. Andersen patent owned by Edwards Lifesciences.

2 Apr 2010

Medtronic commences clinical evaluation of CoreValve transcatheter aortic valve system

Moving to expand the evidence base for the future of structural heart disease therapy, Medtronic, Inc., today announced the start of the first of several new initiatives in a robust international clinical program for its CoreValve transcatheter aortic valve system, a minimally-invasive alternative to open-heart surgery for aortic valve replacement.

15 Mar 2010

In future, less invasive transcatheter heart valve replacements will benefit people with heart disease

A significant number of people with heart disease will benefit from less invasive transcatheter heart valve replacements in future, finds a review of updated practices in CMAJ.

9 Mar 2010

St. Jude Medical's Trifecta valve receives CE Mark approval

St. Jude Medical, Inc. today announced that it has received CE Mark approval for the Trifecta™ valve, marking the Company’s launch into the market for pericardial aortic stented tissue valves.

2 Mar 2010

Half of eligible patients are not getting aortic valve replacement due to fear of surgery

Fear about the risk of surgery is among the reasons half of eligible patients are not getting aortic valve replacement surgery, according to a study by physicians at the University of Michigan Health System.

17 Nov 2009

Direct Flow Medical releases clinical results of its new Percutaneous Aortic Valve System

Direct Flow Medical, Inc., www.directflowmedical.com, released its 12 month data from the initial clinical trial for a new device to treat valve disease without invasive thoracic surgery. Direct Flow Medical is a privately held, emerging medical device company developing a next-generation, catheter based, percutaneous delivered prosthetic aortic valve.

6 Oct 2009