First implantable treatment for heart-failure approved
Wednesday, July 11, 2001
Medtronic got the go-ahead Tuesday from a Food and Drug Administration panel for a first-of-its-kind treatment for heart failure, the leading cause of hospital admissions in this country.
The device, the size of a half-dollar and surgically implanted in the same manner as a pacemaker, is the first of a class that could improve the quality of life for hundreds of thousands of people who suffer from the chronic condition.
The panel's decision is expected to be followed by full FDA approval later this year. The device, which Fridley-based Medtronic has named the InSync, could be available by December, analysts said.
The panel also rejected a request by Indianapolis-based Guidant Corp. for approval of a similar heart-failure device that is already in use in Europe.
That decision was a blow both to Guidant and to heart-failure patients who also suffer from fibrillation, the too-fast beating of the heart, since the Guidant device is also meant to control that condition.
Analysts said it might be 2003 before Guidant, which employs about 2,200 people in its cardiac rhythm management operation in Arden Hills, can introduce a product to the potentially lucrative U.S. heart failure market.
Still, health care observers said the approval of any implantable treatment for heart failure is a landmark for medicine.
"It's a major breakthrough in that it's the first time that a device has been approved for management of heart failure," said Dr. Jay Cohn, professor of medicine at the University of Minnesota medical school and former president of the Heart Failure Society of America.
U.S. Bancorp Piper Jaffray analyst Thomas Gunderson said the implications of the FDA decision are great.
"With the size and potential of the market, the closeness of the race and the two biggest cardio-vascular companies competing, I have not seen a panel meeting as anticipated and watched this closely in four or five years," he said.
Heart failure is the leading cause of admissions to U.S. hospitals, according to the Centers for Disease Control. About 5 million Americans have the condition, and about 70 percent of them are 60 or older.
Each year, about 500,000 new cases are diagnosed and that number has been projected to grow as the baby boom generation ages.
The panel approval was expected for Medtronic; the rejection of Guidant's application was not. Panel members noted that Guidant's device, called the Contak CD, did not meet a pre-determined goal for cutting the progression of heart failure.
Heart failure, also called congestive heart failure, is a condition in which a damaged or overworked heart can't pump enough blood to meet the body's needs. Heart attacks, high-blood pressure and valve disease are among the leading precursors to heart failure. Its symptoms include fatigue, chest congestion and buildup of fluid in the abdomen, feet or legs.
Currently, drugs are the only treatment. They are prescribed to relax and widen the heart vessels and to remove excess fluid.
Unlike drugs, the implanted device is able to resynchronize the pumping of the heart via electrical current to make it more efficient.
Implanted under the skin of the upper left chest with three lead wires routed to the heart area, the InSync is meant for use in tandem with drugs. It's aimed at about 15 percent of heart-failure patients -- those moderately to severely affected.
Research submitted to the FDA showed that patients who received the device were better able to stand exertion and conduct their everyday activities. The use of Insync also reduced the number of days patients were hospitalized, compared with a control group.
"InSync provides substantial benefits over and above drug therapy" for some people "who are among the sickest patients within the health care delivery system," said Dr. William Abraham, the lead clinical investigator for the Insync trial.
Guidant's device, which the company still hopes to see approved, is also aimed at a subset, heart-failure patients in need of both resynchronization and defibrillation.
The advances in treatment come at a cost; Medtronic's device is priced at about $8,500, while Guidant's is about $25,000.
"It's obviously more expensive than taking a pill," Cohn said. "But these are people that are already treated with medication. This could be significant."
-- Terry Fiedler is at email@example.com