Healthcare Industry News: quality assurance
News Release - May 9, 2007
Acorn Cardiovascular to Conduct 50-Patient Confirmatory Trial for FDA Approval of CorCap(TM) Cardiac Support Device
Company to raise additional $15 million to fund new trialST. PAUL, Minn.--(HSMN NewsFeed)--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 precludes the need to perform a sternotomy.
"The ability to implant the CorCap CSD through a less invasive process is an exciting development," said Lunsford. "However, the potential of this advancement would have been limited without FDA approval of the CorCap CSD confirmatory trial."
About Heart Failure
Heart failure is a progressive and debilitating disease that stems from heart muscle damage often caused by heart attacks, heart valve disorders or uncontrolled high blood pressure. As the heart works to supply the body with adequate blood, the stress on the heart builds in a degenerative cycle of muscle damage, often leading to an unhealthy expansion of the heart.
Up to 50 percent of patients with advanced heart failure die within five years of diagnosis. Heart failure affects more than five million people in the United States and 25 million people worldwide. The alarming growth rate - an estimated 550,000 new cases are diagnosed each year in the United States alone - led the U.S. National Heart, Lung and Blood Institute to categorize heart failure as an epidemic.
About Acorn Cardiovascular
Acorn Cardiovascular is a privately held medical device company located in St. Paul, Minn. Incorporated in 1996, Acorn Cardiovascular develops innovative and effective treatments for patients with heart failure. The company's introductory product, the CorCap(TM) Cardiac Support Device (CSD), is intended to improve the heart's structure and function, leading to potential improvements in the quality and duration of a patient's life. For more information about Acorn Cardiovascular and the CorCap CSD, visit www.acorncv.com.
Source: Acorn Cardiovascular
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