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KCI's Prevena Incision Management System receives FDA clearance

Kinetic Concepts, Inc. announced today it has received 510(k) clearance from the Food and Drug Administration for the Prevena Incision Management System, a negative pressure wound therapy product designed for management of surgically closed incisions. KCI estimates more than three million procedures are performed each year worldwide that could benefit from treatment with the Prevena System, representing a potential global opportunity greater than $1 billion.

16 Jun 2010

First hospital in Mexico to use GORE HELEX Septal Occluder for transcatheter closure of ASD

W. L. Gore & Associates (Gore) today announced that Instituto Nacional De Cardiologia in Mexico City, Mexico, is the first hospital in the country to use the GORE® HELEX Septal Occluder for the transcatheter closure of an atrial septal defect (ASD). Department Chief, Dr. Carlos Zabal and Dr. Jose Garcia Montes of the Instituto Nacional de Cardiologia, in Mexico City, achieved the milestone procedure in March, 2010.

14 Jun 2010

Infants born with complex congenital heart disease also at risk for life-threatening gastrointestinal diseases

Infants born with complex congenital heart disease are not only at risk for serious heart-related complications, but also for developing a deadly bowel disease, regardless of the type of surgical intervention they receive for their heart. These are the findings from a study by Nationwide Children's Hospital, and appearing in Pediatric Critical Care Medicine published online May 6 ahead of print.

27 May 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

EIRMC, West Valley Medical Center to continue to serve Humana's Medicare Advantage members

Eastern Idaho Regional Medical Center (EIRMC), a full-service regional medical center in Idaho Falls, and West Valley Medical Center, a community hospital in Caldwell, will continue to provide in-network medical care to all Medicare Advantage members enrolled in plans offered by Humana, under terms of a renewal agreement announced today.

26 May 2010

New Melody Transcatheter Pulmonary valve helps congenital heart defect patients avoid multiple surgeries

Congenital heart defects are the most common type of major birth defect in the U.S., affecting about 25,000 babies each year. Now, a new valve being used at the University of Michigan's C.S. Mott Children's Hospital Congenital Heart Center can help patients delay or avoid multiple surgeries.

13 May 2010

Fibrinogen may reduce bleeding complications in cardiac surgery, says study

A joint clinical trial conducted by the University Hospital and the University of Gothenburg, Sweden, found that an element in human blood, fibrinogen, is likely more vital to the blood's clotting ability in connection with heart surgery than previously considered. If

10 May 2010

Open-heart surgery brings life back to 7-year-old boy

A 7-year-old boy who was brought to the United States to have his congenital heart defect repaired had successful open-heart surgery Thursday at the Children's Center at Sutter Medical Center, Sacramento by pediatric cardiothoracic surgeon Teimour Nasirov, M.D., and assisted by Mohan Reddy, M.D., an internationally renowned pediatric heart surgeon from Lucile Packard Children's Hospital at Stanford.

17 Apr 2010

New UCLA study compares safety and efficacy of angioplasty to bypass surgery

At 56, Tim Obrenski found himself getting so exhausted that he couldn't even pull weeds from his garden. A visit to the cardiologist uncovered a major blockage in his heart's left main artery, and he was told he needed bypass surgery.

15 Apr 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

FDA approves OrSense's NBM-200MP non-invasive oximetry and low signal oximetry sensor

OrSense Ltd., developer of monitors for non-invasive measurements of various blood parameters, announced today it has received U.S. Food and Drug Administration (FDA) approval for NBM-200MP, a non-invasive oximetry and low signal oximetry sensor.

23 Mar 2010

Mitral regurgitation: MitraClip safe, effective alternative option to open heart surgery

NorthShore University HealthSystem (NorthShore) interventional cardiologist, Ted Feldman, MD, presented data today at the American College of Cardiology annual scientific sessions from the EVEREST II trial (Endovascular Valve Edge-to-Edge REpair STudy) demonstrating the MitraClip, a novel, first-in-class catheter-based device, is a safe and effective alternative to open heart surgery for select patients with mitral regurgitation.

15 Mar 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

ICAP Ocean Tomo offers Medcanica's patent portfolio for sale

ICAP Ocean Tomo, the intellectual property brokerage division of ICAP plc (IAP.L), is offering for sale a patent portfolio relating to a cardiothoracic surgery system owned by Medcanica, LLC. The portfolio consists of 14 U.S. issued patents, 4 non-U.S. patents, and 1 U.S. patent application.

17 Feb 2010

Edwards Lifesciences’ German Andersen patent not infringed by Medtronic's CoreValve transcatheter aortic valve system

Medtronic, Inc., announced today that an appeals court in Germany has found that the CoreValve® transcatheter aortic valve system does not infringe Edwards Lifesciences’ German Andersen patent, which is set to expire in May 2011. The appellate court’s decision upholds a lower court’s ruling and enables uninterrupted access to the leading transcatheter heart valve in Germany.

11 Feb 2010

HealthSpring nurse practitioner identifies impending heart attack

Olive Branch, Miss. resident Glenn Lusk has a special perspective on the value of his Medicare Advantage plan. It was a HealthSpring-contracted nurse practitioner who discovered during a home visit in November that Lusk was experiencing serious heart trouble.

6 Feb 2010

New technique may reduce recovery time in arrhythmia patients

A surgeon and an electrophysiologist in the Methodist DeBakey Heart & Vascular Center last week worked together to perform a novel, minimally-invasive procedure to treat a common but dangerous arrhythmia in a 61-year-old lawyer from east Texas who has suffered from the condition for months.

4 Feb 2010

Medtronic' Melody Transcatheter Pulmonary Valve receives FDA approval under HDE

In a significant development for congenital heart disease patients, Medtronic, Inc. (NYSE: MDT), announced today that its Melody® Transcatheter Pulmonary Valve has received U.S. Food and Drug Administration (FDA) approval under a Humanitarian Device Exemption (HDE).

27 Jan 2010

FDA approves first heart valve conduit that can delay need for open-heart surgery

The U.S. Food and Drug Administration today approved the Medtronic Melody Transcatheter Pulmonary Valve and Ensemble Delivery System, the first heart valve to be implanted through a catheter, or tube, in a leg vein and guided up to the heart. This new approach to the treatment of adults and children with previously implanted, poorly functioning pulmonary valve conduits can delay the need for open-heart surgery.