Edwards Lifesciences Buys Maker of Embolic Protection Devices

Talk about long engagements. After a two-year courtship (some estimates claim the relationship is even older), Edwards Lifesciences Corporation and Embrella Cardiovascular Inc. finally wed in a $43 million merger that closed March 11. Edwards executives claim the deal will bolster the company’s position in the white-hot transcatheter valve market.

Edwards has had its eye on Embrella for at least two years. The Wayne, Pa.-based startup launched in late 2007 and raised slightly under $9 million in two funding rounds, the latest being a Series B round of $6.7 million that closed in August 2009. Edwards was an investor in that financing round, along with BioStar Ventures of Petoskey, Mich., Hatteras Venture Partners of Research Triangle Park, N.C., and MedFocus Fund LLC of Irvine, Calif.

“This acquisition is consistent with our dedication to the ongoing exploration and development of novel technologies that have the potential to improve outcomes for patients, and supports our strategy to extend Edwards’ global leadership in transcatheter heart valves,” Larry L. Wood, Edwards’ corporate vice president, said in a prepared statement. The deal also is consistent with the company’s plan to acquire more new technology this year—in early January, Edwards CEO Michael Mussallem said the company would be investing “aggressively” in its future this year. “We’re going to be substantially increasing our R&D [research and development] by 20 percent [in 2011] and we plan to continue to be a long-term investor,” he noted.

Edwards recently maintained its 2011 sales guidance range of $1.59 billion to $1.67 billion.

Embrella’s Embolic Deflector System is designed to reduce the amount of embolic material that may enter the carotid arteries during endovascular procedures, according to the company. The device is placed in the aorta using a standard 6 French sheath through a right brachial or right radial artery access site. The Embrella Embolic Deflector System received the CE Mark in Europe last May.

Edwards hopes to launch its own Sapien transcatheter valve replacement in the United States this fall. The device is placed either through a transfemoral (RetroFlex 3 Transfemoral Delivery System) or transapical (Ascendra Transapical Delivery System) approach, according to the firm. Edwards’ Sapien valve currently is being evaluated in the treatment of patients with severe calcific aortic stenosis who are considered to be high-risk or non-operable for conventional open-heart valve replacement surgery.