HeartWare International Inc.’s implantable pump extended the lives of heart-failure patients in a study that may help it compete against a similar device that weighs twice as much.
The 5-ounce HeartWare pump, not yet approved in the U.S., is implanted inside the left ventricle to help damaged hearts push oxygen-carrying blood to other organs. After six months, 92 percent on it were alive, had undergone a heart transplant or were improved enough to have the pump removed, researchers said today at the American Heart Association meeting in Chicago.
With U.S. clearance, Heartware, based in Framingham, Massachusetts, would compete in a developing $4 billion market against the 10-ounce HeartMate II, made by Thoratec Corp., of Pleasanton, California. Versions of that product had $230 million in 2009 sales. Lighter pumps can reduce surgical trauma during implantation and use less power, said Mark Slaughter, a University of Louisville surgeon and study researcher.
“The results coming out of the box are very, very strong,” said Keith Aaronson, a cardiologist at the University of Michigan Medical Center in Ann Arbor and the lead investigator, in an interview. “The quality of life for these patients nearly doubled and increased to a level seen in heart transplant patients.”
About 5.8 million people in the U.S. have heart failure, and about one in five will die within one year after being diagnosed, according to the U.S. Centers for Disease Control and Prevention in Bethesda, Maryland. In severe cases, when medicines alone do not work to improve blood flow, a heart pump can be implanted, or a transplant may be needed.
Two Pumps Compared
The company-funded study of 639 patients compared those on HeartWare’s pump, called HVAD, to a national registry of patients, nearly all of whom received the HeartMate II. HeartWare’s 92 percent survival rate compared with a 90 percent rate for the group that got the Thoratec device, though the differences were not statistically significant, Aaronson said.
After one year, 90.6 percent of HeartWare patients were alive compared with 85.7 percent of those in the Thoratec group, Aaronson said.
“The HVAD patients also had substantially less bleeding and infections” than has been found in other studies of patients who got the Thoratec pump, Aaronson said.
The HeartWare patients had “very large” improvements in quality of life measures, including the ability to walk 371 feet further in six minutes than they could prior to the surgery, Aaronson said.
Sold in Europe
HeartWare received approval to sell its HVAD pump in Europe in early 2009, and last year reported $24 million in revenue. The company said it plans to file by year’s end for U.S. approval to use its pump in heart failure patients who are awaiting transplants.
The bigger U.S. market for devices to help people with heart failure may exceed $4.5 billion, said Larry Biegelsen, a Wells Fargo Securities analyst in New York. ‘
Thoratec’s device was cleared in January 2010 in the U.S. as a permanent therapy for heart-failure patients. Gerhard Burbach, the company’s chief executive officer, said in January that Pleasanton, California-based Thoratec is working on a smaller pump to be called the HeartMate III.
Both companies “are attractive acquisition candidates,” said Jason Mills, a Canaccord Adams analyst based in San Francisco, in a telephone interview. “They both have merits. These are the two best assets in one of the fastest-growing medical technology markets over the next half decade.”
Medtronic Inc., of Minneapolis, St. Jude Medical Inc., of St. Paul, Minnesota, or Natick, Massachusetts-based Boston Scientific Corp. “will eventually make a play” for HeartWare or Thoratec because they “rarely ignore in perpetuity a market of this size and growth potential, let alone in their own backyards, such as heart failure,” Mills wrote in a July 28 note to investors.
In February 2009, Thoratec made its own play for HeartWare, offering to buy the company for $283 million. The companies abandoned the merger in July after the Federal Trade Commission said it would challenge the deal.
Doctors will also be taking a close look at the HeartWare study to compare side effects, such as bleeding and blood clots, and the pump’s durability, with the Thoratec device, Biegelsen wrote in a Nov. 5 note to clients. Thoratec’s pump requires more surgery to implant because doctors must cut an area in the patient’s chest in which to fit the device. HeartWare’s pump can be placed on the heart.
“This area of cardiovascular medicine is going to grow, and grow substantially,” said Clyde Yancy, medical director of the Baylor Heart & Vascular Institute in Dallas. “The data is no longer proof of concept. They are no longer showing this can theoretically work; it’s showing we should do this.’