ATS Medical receives European clearance for sutureless heart valve

ats medicalMINNEAPOLIS, Minnesota – Cardiology device maker ATS Medical Inc. has received European regulatory clearance to sell an aortic valve that can be implanted without requiring sutures.

The company said its 3f Enable Aortic Bioprosthesis can be folded to allow placement through a small incision and then expanded once inside a patient. The device allows for less-invasive aortic valve replacement and shorter procedure times than other commercially available alternatives, according to a statement from ATS.

ATS’ stock price rose 5 percent Monday to close at $3.03.

ATS said the product’s release marks the first time a surgical aortic valve that is implanted “using a sutureless technique” has been cleared for commercial use.

ATS plans to release an updated version of the device late next year.

In September, ATS announced that Columbia University Medical Center achieved a milestone 100 implants of the 3f Aortic Bioprosthesis. ATS reported revenue of $18.8 million for the quarter ended Oct. 3, a 17 percent year-over-year increase. Operating loss narrowed to $0.6 million from $2.8 million in the third quarter of 2008.

Brandon Glenn

Brandon Glenn MedCity News

Brandon Glenn is the Ohio bureau chief for MedCity News.

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[...] announced last week that it has received European regulatory clearance to sell its 3F Enable Aortic Bioprosthesis. The [...]

Comment by ATS Medical gets patent for laser-cutting technology used in heart procedures : MedCity News — December 15, 2009 @ 11:03 am

[...] said it expects sales to pick up in the second half of this year as it expands the rollout of its 3f Enable sutureless heart valve, which recently received European regulatory [...]

Comment by ATS Medical’s stock plummets on projections of fourth-quarter loss : MedCity News — January 12, 2010 @ 1:58 pm

[...] says the Enable, which received European regulatory clearance in December, is the first surgical aortic valve replacement approved for commercial use that is [...]

Comment by ATS Medical reports first commercial procedure using its sutureless aortic vavle : MedCity News — January 25, 2010 @ 10:46 am

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