Embrella Cardiovascular

Embrella Cardiovascular, Inc. operated as a medical device company with a focus on enhancing cerebral protection during cardiovascular procedures. Founded in 2007 and headquartered in Wayne, Pennsylvania, the company concentrated on developing solutions to reduce the risk of embolic strokes, which can occur when debris is dislodged during interventional heart procedures.

The company was started and led by Jeffrey O'Donnell, Sr., an executive with extensive experience in the medical device sector, having previously served as President and CEO of companies like PhotoMedex and Kensey Nash Corp. His background in leading emerging medical firms was instrumental in guiding Embrella from its initial concept to a successful exit. The firm's strategy involved addressing a critical unmet need in the growing market of transcatheter heart valve procedures, targeting interventional cardiologists as its primary client base.

Embrella Cardiovascular's core product was the Embrella Embolic Deflector System, a single-use, disposable device designed to be used during procedures like Transcatheter Aortic Valve Implantation (TAVI). The device is inserted through a sheath in an artery and positioned in the aorta. Its key feature is a porous membrane that shields the carotid arteries, deflecting potential embolic material away from the brain while allowing blood to flow unimpeded. The system gained a significant milestone by receiving the CE Mark in Europe in May 2010, permitting its commercialization in countries recognizing this approval. This achievement was funded by approximately $9 million raised through investors including BioStar Capital, Hatteras Venture Partners, MedFocus, and Edwards Lifesciences.

The company's trajectory culminated in a strategic acquisition by Edwards Lifesciences Corporation (NYSE: EW) in March 2011 for approximately $43 million in cash. The acquisition was a strategic move for Edwards Lifesciences, a global player in heart valves, to bolster its portfolio of technologies that improve patient outcomes in transcatheter heart valve replacements. Keywords: Embolic protection, cardiovascular devices, transcatheter aortic valve implantation, TAVI, cerebral embolic protection, aortic embolic protection, embolic deflector system, medical device, interventional cardiology, stroke prevention, surgical devices, heart valve procedures, CE Mark, MedTech acquisition, atheromatous plaque, embolization, carotid arteries, Edwards Lifesciences, Jeffrey O'Donnell Sr., BioStar Ventures