May 9 2007, 4:32 PM EST
News source: Business Wire
Acorn Cardiovascular announced today that the Food and Drug Administration (FDA) will consider approval of the CorCap Cardiac Support Device (CSD) based on the successful completion of a prospective confirmatory trial that addresses issues raised by the Medical Device Dispute Resolution Panel and the Circulatory System Devices Panel. The company had completed a 300-patient prospective, randomized pivotal trial and submitted data to the FDA in 2004. However, the two panels voted against approval for the CorCap CSD in December 2006 and June 2005, respectively, citing the need for additional clinical data.
Since the MDDRP decision last year, Acorn Cardiovascular has worked closely with Dan Schultz, M.D., Director of the Center for Devices and Radiological Health (CDRH), and Bram Zuckerman, M.D., Director of the Division of Cardiovascular Devices, to design a confirmatory trial that would alleviate the concerns of the panels. Dr. Schultz is the highest ranking official at FDA with responsibility for the assessment of medical devices. The confirmatory trial will assess a patient population that demonstrated the greatest clinical benefit in the pivotal trial. If Acorn meets the success criteria for the confirmatory trial, it is expected that FDA may be able to approve the device without engaging a third advisory panel.
"By considering data from a 50-patient confirmatory trial, the FDA has developed a potentially more expedient pathway to approve the CorCap CSD," said Rich Lunsford, chief executive officer, Acorn Cardiovascular. "The faster we can move through the next phase of the approval process, the sooner we can offer this device to thousands of patients who face significant limitations and reduced quality of life due to heart failure."
The confirmatory trial will involve 50 patients in key investigational sites selected from the original 29 pivotal trial site locations. Dr. Michael A. Acker, Chief of the Division of Cardiac Surgery at the University of Pennsylvania, will serve as principal investigator (PI) of the confirmatory trial. Sites should start enrolling patients in summer 2007, with the aim of completing enrollment in early 2008. Following a six-month follow-up period and pending positive results, the company anticipates approval to occur by the end of 2008 or the beginning of 2009.
"The confirmatory trial will build upon - both clinically and statistically - the positive outcomes from the original 300-patient pivotal trial and is designed to address the specific clinical data requests from both panels," said Steve Anderson vice president of Regulatory and Quality Assurance at Acorn Cardiovascular.
The CorCap CSD is a mesh wrap that is placed around the heart to support and relieve stress on the heart muscle. As heart failure progresses, the heart enlarges and becomes increasingly less efficient at pumping blood. The CorCap CSD is intended to improve the heart's size, shape and function. More than 465 patients worldwide have received the new treatment. The CorCap CSD received CE Marking approval in Europe in 2000.
Company Plans to Raise Money to Fund Trial
The company must immediately raise an estimated $15 million to complete the confirmatory trial. Many of the original investors have agreed to support Acorn Cardiovascular through the next phase of the FDA approval process and the assumed commercial launch of the device. In addition, several cardiovascular companies and venture capital firms have expressed interest in providing needed funding.
Minimally Invasive CorCap CSD Procedure Performed
Doctors in Europe, where the device has been used since 2000, recently performed two CorCap CSD cases with a less-invasive thoracotomy procedure that involves entering the chest cavity through a two-and-a-half-inch incision in the left side of the rib cage. The thoracotomy procedure takes approximately one hour and precl
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