A Medical Device Daily

MedicalCV (Inver Grove Heights, Minnesota) on Friday said it would discontinue distribution of its Omnicarbon mechanical heart valve product line at the end of this fiscal year, that date being April 30.

Marc Flores, president and CEO of MedicalCV, said, “Since November 2004, management and the board of directors have been evaluating and seeking strategic alternatives for the Omnicarbon mechanical heart valve product line. We previously announced [Medical Device Daily, Sept. 24, 2004] that we were discontinuing the manufacture of valves. We have now determined to exit the heart valve segment entirely. We were unable to generate a viable opportunity to dispose of this product line, and it had become a continuing diversion of management and board time.”

He said that the company now would focus “on building industry support and acceptance” for its Atrilaze Surgical Ablation System.

Flores said, “We are very excited about our AtriLaze technology and the significant market opportunity it offers for the treatment of atrial fibrillation that we must commit all of our resources to the AtriLaze system.”

He added: “The recently announced closing of private financing provides us the capital resources to continue development of a stand-alone, minimally invasive surgical procedure for the treatment of atrial fibrillation. The AtriLaze system is already gaining industry traction and recognition, as it received an excellence in technology award for its technology from Frost & Sullivan, a leading industry market research firm.”

MedicalCV developed Omnicarbon mechanical heart valves using its pyrolytic carbon processes. Although the company ceased manufacturing new heart valves in September 2004, it continued to maintain the mechanical heart valve business, supporting customers and distributors during the divestiture process. The company acquired the AtriLaze Surgical Ablation System from LightWave Ablation Systems (Mooresville, North Carolina). in August 2003 and received FDA 510(k) clearance in November 2004.