Acorn Device Shouldn't Be Approved, U.S. Panel Says (Update3)

By Avram Goldstein

Dec. 15 (Bloomberg) -- Acorn Cardiovascular Inc.'s ``heart sock'' device shouldn't win U.S. approval because data from clinical trials weren't conclusive, government advisers voted.

The mesh device, designed to keep failing hearts from losing pumping power, wasn't shown to be safe and effective, a committee hearing an appeal by closely held Acorn ruled today. The Food and Drug Administration had twice denied approval for the St. Paul, Minnesota-based company.

Representatives of heart-device makers jammed the hearing in Gaithersburg, Maryland. Acorn argued that a trial with 300 patients showed its device might help heart-failure patients. About 550,000 Americans are diagnosed with the condition each year. Acorn said its investors include Johnson & Johnson, the world's biggest maker of medical devices; Credit Suisse; and Piper Jaffray & Co.

``I have implanted 10 of these devices, and I implore that the panel approve this,'' said Mercedes K.C. Dullum, a heart surgeon with the Cleveland Clinic in Weston, Florida, in testimony to the panel.

Advisory panel recommendations, while not binding, usually are followed by FDA officials. The committee voted 3-1 against recommending approval.

``This has been agonizing because we are extremely sympathetic to the investigators,'' said panel member Warren Laskey, a cardiologist at the University of New Mexico in Albequerque who opposed approval. ``We're bending over backwards to try to find a reason to help patients who fall into this niche, but we can't look away from the safety signal.''

The agency said it should have a decision in about 45 days. Today's meeting was only the second time a company has used an appeals process created by Congress in 1997 to resolve scientific disputes over FDA rulings. Most companies work out such differences through negotiation.

``Sometimes when you're first, it's painful,'' said Acorn vice president Steven Anderson in an interview. ``It's not easy to come up with novel therapies.'' The CorCap received European approval in 2000.

Acorn has raised $80 million to develop its device since the company's 1996 founding, he said. Acorn Chief Executive Officer Richard Lunsford said in an interview after the meeting that he would confer with the company's investors, who have indicated interest in funding a trial that will satisfy the FDA. The company also is developing a way to implant the CorCap without opening the chest, he said.

Enlarged Hearts

Patients with heart failure often develop enlarged hearts as scar tissue builds up. The bigger the heart gets, the less efficiently it pumps oxygen-carrying blood around the body, leaving patients gasping for air and exhausted from everyday activities. As many as half of patients with advanced heart failure are dead within five years of diagnosis, Acorn said.

Researchers supporting Acorn said its CorCap device decreases pressure in the ventricles, the two large lower chambers of the heart, and reduces stress in the walls of the heart while allowing tissue to repair itself in a process known as ``reverse remodeling.'' In some cases, Acorn said, heart size decreased.

Lunsford in a Dec. 13 interview said today's meeting might help device makers learn more about how the FDA uses statistical measures to evaluate devices for treating heart failure.

``The entire heart-failure specialty is looking to try to understand what's the best way to configure heart-failure trials, which are challenging to structure,'' Lunsford said.

Warnings on Data

Acorn repeatedly ignored warnings about its statistical methods and provided data that was ``not interpretable'' and didn't address agency safety concerns, FDA officials said today. The agency's stance dovetails with the recommendation of a 2005 panel, that panel's chairman told the appeal committee today.

``In the end, the panel felt there was an absence of a reasonable assurance of safety,'' said the 2005 panel chairman, Harvard associate professor William Maisel. ``There's a lot of missing data.'' A third of control-group patients got better without CorCap, Maisel said.

Some patients who have received the polyester mesh CorCap device said it improved their lives. Nellie Wosu, 46, a former technology manager at a New York investment bank now living in Concord, North Carolina, said she met with funeral directors to make her own arrangements before she got a CorCap in 2002.

``I once again have my zest for living,'' she said in a Dec. 12 telephone interview. ``I don't have machines at night pumping all around me. I had asked every doctor I could imagine to help me because there was no hope. Now I expect to live a long, long time.''

Robert Stoddard, 78, a retired geography professor in Lincoln, Nebraska, said things have improved since the CorCap was implanted in May 2005.

``I feel like I've got a new lease on life, and I can't help but think the CorCap is a big factor in it,'' he said in a Dec. 13 telephone interview. Stoddard is again hiking, bicycling and working on his land, albeit more slowly than before, he said.

To contact the reporter on this story: Avram Goldstein in Washington at agoldstein1@bloomberg.net .

Last Updated: December 15, 2006 19:08 EST