A Medical Device Daily
CryoCor (San Diego) yesterday reported that it will be delayed in filing an amendment to its pre-market approval application for the treatment of atrial flutter (AFL).
CryoCor said it expects the amendment to be filed with the FDA by the end of November.
Ed Brennan, president/CEO of CryoCor, said, “We believe the additional time will allow us to provide supplementary information to these data. We will be presenting our strongest case and look forward to working with the FDA in seeking approval for the treatment of AFL with our system.”
CryoCor manufactures a disposable catheter system based on its cryoablation technology for the minimally-invasive treatment of cardiac arrhythmias. The CryoCor Cardiac Cryoablation System is designed to treat arrhythmias through the use of cryoenergy to destroy targeted cardiac tissue. The Cryoablation System has been approved in Europe for the treatment of AF and AFL, the two most common and difficult-to-treat arrhythmias, since 2002. In the U.S., it is conducting a pivotal trial to evaluate the safety and efficacy of the aystem to treat AF.
People in Places
• Jeffrey J. Langan has been named president/CEO of Cambridge Heart (Bedford, Massachusetts). Langan succeeds David Chazanovitz, who resigned after six years as president/CEO of the company. Langan has served as a member of the company’s board since 1999. Langan is founder and a principal of Maine Point Associates, a business consulting firm. Cambridge Heart develops products for the noninvasive diagnosis of cardiac disease.
• Mark D. Carlson, MD, has been named chief medical officer and senior vice president, clinical affairs, of the cardiac rhythm management division of St. Jude Medical (St. Paul, Minnesota). Carlson most recently served as professor of medicine and associate vice president for government relations at Case Western Reserve University in Cleveland.