Novel Implanted Heart Device Designed to Treat Effects of Heart Failure to Be Considered By Medical Device Dispute Panel
Posted on: Tuesday, 12 December 2006, 09:01 CST
Acorn Cardiovascular:
WHAT: The Food and Drug Administration (FDA) will convene a Medical Device Dispute Resolution Panel (MDDRP) on Dec. 15 to consider the first device to specifically treat enlarged hearts and potentially reduce heart failure progression. Acorn Cardiovascular's CorCap(TM) Cardiac Support Device is a mesh wrap that is placed around the heart to provide support of the muscle and reduce ventricular enlargement. More than 465 patients worldwide have received the new treatment.
In 2005, an FDA advisory panel recommended against approval of the device. The FDA subsequently determined that a small confirmatory trial would be needed for approval. Acorn's experts disagreed with this assessment and requested a referral to the MDDRP. This panel will evaluate the data and make a recommendation to the Centers for Devices and Radiological Health (CDRH) Director. This marks only the second time that such a panel has been convened to adjudicate a dispute between the FDA and a sponsor.
WHEN/WHERE: 8 a.m. ET Hilton Washington DC North/Gaithersburg Friday, Dec. 15 Salons A, B and C 620 Perry Pkwy. Gaithersburg, Md.
INTERVIEWS/PHOTOS:
Acorn Cardiovascular's Richard Lunsford, president and CEO; Spencer Kubo, MD SVP and global medical director; and Steven Anderson, VP, corporate assurance.
Device investigators: Douglas Mann, MD, Professor of Medicine-Cardiology, Baylor College of Medicine; Mariell Jessup, MD, Director of Heart Failure and Cardiac Transplant Programs, Hospital of the University of Pennsylvania; Hani Sabbah, PhD, Director of CV Research, Henry Ford Hospital; Randall Starling, MD, Head, Section of Heart Failure and Cardiac Transplant Medicine, Cleveland Clinic Foundation; and Michael Acker MD, Chief, Division of Cardiac Surgery, and Surgical Director, Heart Transplantation and Mechanical Assist Programs, Hospital of the University of Pennsylvania.
High-resolution photos and animation of the device are available for download at www.acorncv.com. B-roll is available by request.
ABOUT HEART FAILURE:
An enlarged heart often develops with heart failure, a progressive and debilitating disease. An oversized heart cannot efficiently pump blood to meet the body's needs, causing patients to become fatigued and short of breath even with everyday activities, such as climbing stairs or walking short distances. Currently, 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 develops innovative and effective treatments for patients with heart failure. The company's introductory product, the CorCap™ 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: Business Wire
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