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Structural & Congenital Heart Disease

 

Children who survive cardiac surgery as infants have a 20-fold risk of hearing loss when compared to peers without heart defects, according to a study in the Journal of Pediatrics.

The self-expanding Centera transcatheter heart valve has received CE mark approval, device manufacturer Edwards Lifesciences announced Feb. 15.

Survivors of childhood heart defects are more likely than the general population to develop dementia, including at earlier ages, researchers reported Feb. 12 in Circulation.

US News & World Report issued their rankings for the top 10 hospitals for pediatric cardiology and heart surgery in the country.

New research published in the Journal of the American Medical Association suggests a patent foramen ovale (PFO), colloquially known as a hole in the heart, can double the risk of stroke within 30 days of non-cardiac surgery.

 

Recent Headlines

Edwards enrolls patients into trial to evaluate trancatheter heart valve Edwards Lifesciences has begun enrolling patients into the PREVAIL Japan clinical trial to study the safety and efficacy of transcatheter aortic heart valves, specifically its Sapien XT.
University of Colorado Hospital Puts Patient Hearts into Physicians Hands A process called rapid prototyping allows interventionalists to produce 3D models of patients hearts to better facilitate pre-procedural planning for catheter-based structural heart interventions.
Circulation: Transcatheter valve-in-valve implants are 98% effective When bioprosthetic valves fail, transcatheter valve-in-valve implantation may be a viable option used to mend aortic, pulmonary, mitral and tricuspid tissue valves, based on a study published in Circulation on April 12.
FDA warns Edwards for not reporting heart valve concerns
Due to an inspection of Edwards Lifesciences in Irvine, Calif., on Sept. 9, 2009, through Sept. 16, 2009, the FDA has sent a warning letter to the company, stating that its annuloplasty ring devices and its pericardial heart valve device are misbranded.
Medtronic to appeal heart valve patent loss, $74M reward to Edwards
After a long standing lawsuit involving Medtronic and Edwards Lifesciences, the U.S. District Court of the District of Delaware has ruled in favor of Edwards, rewarding the company $73.5 million, after finding Medtronic guilty of infringing upon Edwards' U.S. Andersen transcatheter heart valve patent. However, Medtronic said that it plans to appeal the jurys verdict in the case, filed February 2008, involving the CoreValve transcatheter aortic valve system.
AGA to pay Medtronic $35M in stent patent settlement Medtronic and AGA Medical have settled a patent infringement lawsuit filed by Medtronic in 2007 alleging that all of AGA's Amplatzer occluder and vascular plug devices infringe three of Medtronic's method and apparatus patents on shape memory alloy stents (U.S. Patent Nos. 5,190,546, 6,306,141 and 5,067,957, collectively known as "the Jervis patents").
Percutaneous Aortic Valve Replacement: A Chance for the Untreatable? While percutaneous aortic valve replacements have been performed for more than six years in Europe, the option is not available to U.S. patients with severe aortic stenosis (AS) who are not surgical candidates, except for the select few enrolled in the Edwards Lifesciences PARTNER trial. With Medtronic applying for an FDA investigational device exemption (IDE), and a few other players emerging in Europe, the market seems explosive, but many clinical, ethical and financial questions need to be addressed before this therapy becomes a standard part of clinical practicein the U.S.
Medtronic launches CoreValve transcatheter aortic valve trial Medtronic has commenced an international clinical program for its CoreValve transcatheter aortic valve system, a minimally-invasive alternative to open-heart surgery for aortic valve replacement.
CMAJ: Transcatheter valve replacement safe, but needs more research Minimally invasive transcatheter approaches to repair the aortic and pulmonic valves can be safe, cause less mortality and provide faster recovery times compared to previous methods. However, further clinical trials are still needed, according to a review published March 8 in the Canadian Medical Association Journal.
CRT: FDA inches closer to defining TAVI standards for low-risk patients
Washington, D.C.--Matthew G. Hillebrenner, MSE, chief of the FDAs circulatory support and prosthetics branch, division of cardiovascular devices at the Office of Device Evaluation, spoke to the complications yet exciting progress with identifying how to trial and treat the low-risk operable patient population with trancatheter aortic valve implantation (TAVI), on Feb. 22 at the Cardiovascular Research Technologies (CRT) conference.

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