It doesn't hurt to launch a new medical device right before a large meeting of doctors who actually use the product begins.
On Tuesday, three big medical technology companies in the Twin Cities did just that. Fridley-based Medtronic announced Food and Drug Administration (FDA) approval of a portfolio of heart and cardiac resynchronization defibrillators -- which the company says offers "unparalleled depth and breadth" in treating irregular heart rhythms, heart failure and sudden cardiac death.
By the end of the day, rival Boston Scientific Corp. had said it received FDA approval for two new defibrillators of its own. The platform of devices, CEO Jim Tobin said, incorporates "truly breakthrough technologies."
Meanwhile, St. Jude Medical Inc., of Little Canada, announced FDA and European regulatory approval of a new small-diameter pacemaker lead.
The news comes as thousands of cardiologists gather today in San Francisco for the Heart Rhythm Society's annual scientific meeting. "Obviously the companies want to make a big splash before a big meeting," said Timothy Nelson, an analyst with FAF Advisors.
It's unclear whether the marketing push will jump-start the otherwise sluggish $5.5 billion worldwide market for defibrillators.
Implants of the stopwatch-sized devices declined after a series of safety-related recalls beginning in 2005.
Implantable cardioverter defibrillators (ICDs) are implanted in the chest and shock an errantly beating heart back into rhythm. Cardiac resynchronization therapy (CRT) devices also are implanted in the chest, but recoordinate the action of the right and left ventricles in patients with heart failure. The devices range in price from $20,000 to $35,000.
Medtronic's new "Vision 3D portfolio," which includes six defibrillators and CRT devices, received FDA and European regulatory approvals last month. (The FDA did not issue a formal press release.)
While some of the Vision 3D technology has been available in earlier versions of Medtronic products, it is unique because all of the devices are designed off a common platform, Nelson said.
This is important, he said, because future versions of new products on this platform can be developed faster and win regulatory approval quicker -- a process that typically is lengthy and expensive for device-makers.
Because defibrillators are now essentially commodity products, Nelson said the three major companies making them compete by offering doctors unique features.
"We're trying to develop devices with different product features, so the physician can choose which one is right for the patient," said Dr. David Steinhaus, chief medical officer of Medtronic's Cardiac Rhythm Disease Management business. "With the cost-conscious society we have right now, that's very important."
Meanwhile, Boston Scientific said it received FDA approval of the Cognis cardiac resynchronization therapy defibrillator and the Teligen defibrillator, which the company said are among the world's smallest and thinnest. The products will be manufactured in Arden Hills, where the company employs about 3,000 people.
Janet Moore • 612-673-7752