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The FDA has recently approved the Impella 2.5 System by Abiomed. The miniature blood pump is designed for temporary use in patients with severe symptomatic coronary artery disease (CAD) and diminished heart function who are undergoing high risk percutaneous coronary intervention (PCI) such as angioplasty, when a blocked artery is unclogged using an inflated balloon. The device will help maintain heart function and circulation during PCI when surgical revascularization isn’t an option.
In a statement, the FDA said that the device “may allow a longer and more thorough procedure by preventing episodes of hemodynamic instability (e.g., poor circulation, low blood pressure) due to temporary abnormalities in heart function.”
“The rigorous data from FDA clinical trials such as PROTECT I and PROTECT II demonstrate that complex, high-risk patients undergoing protected PCI with Impella 2.5 support experience reduced adverse events, improved quality of life and are able to return home faster with fewer repeat procedures,” said William O’Neill, M.D., Henry Ford Hospital in Detroit. “The heart team approach has evolved into a mainstream practice recognized by the guidelines for determining the need for PCI versus surgery and will continue to act as a platform for the screening and determination of the appropriate revascularization treatment for this high risk patient population.”
“As heart disease patients get sicker, more complex, and desire minimally invasive solutions, there are few options available to them to help improve their quality of life in a cost effective manner,” said Michael Minogue, chairman, president and chief executive officer, Abiomed. “We are excited that Impella has been recognized as a device that can potentially become the new standard of care with a ‘first of its kind’ approval.”
The Impella System is produced by Abiomed Inc., based in Danvers, Mass.
For more information on Abiomed: www.abiomed.com
To view the full FDA press release, click here
For Further Information
More on the U.S. markets for cardiac surgery and heart valve devices can be found in the 2014 edition report published by iData entitled U.S. Markets for Cardiac Surgery and Heart Valve Devices, which covers market segments for the following: tissue heart valves, mechanical heart valves, annuloplasty repair, transcatheter mitral valve repair, transcatheter heart valve implantation, on-pump coronary artery bypass, off-pump coronary artery bypass, endoscopic vessel harvesting, anastomosis assist, cardiac ablation, transmyocardial revascularization, ventricular assist, intra-aortic balloon pumps, artifical hearts, patent foramen ovale, and atrial and ventricular septal devices.
Recent reports on the markets for cardiac surgery and heart valve devices cover the U.S. and 15 countries in Europe. Full reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment.
Register online or email us at [email protected] for a U.S. Markets for Cardiac Surgery and Heart Valve Devices report brochure and synopsis.
About Procedure Tracker
Procedure number data is available from iData’s Procedure Tracker service, which allows subscribers to define and analyze procedure data segmented by country, region, hospital, surgery centre, and physician. A customizable dashboard sorts procedure data for further analysis and research.
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