Medtronic Heart Devices Get FDA’s OK : Health: New defibrillators are simpler to implant, require less surgery and time in the hospital.
Medtronic Inc. has received approval for a heart-rhythm regulator that is simpler to implant than earlier versions and thus results in shorter hospital stays and savings for patients.
With Monday’s announcement that its Jewel line of defibrillators has been approved, Medtronic shares gained $2.375 to close at a 52-week high of $70 on the New York Stock Exchange.
Medtronic said the Food and Drug Administration approved five models of the Jewel on Friday. Most industry analysts had not expected the approval for several more months.
Defibrillators implanted in the body detect an often-fatal condition called fibrillation, when the heart flutters uncontrollably and fails to pump blood. As do the double-padded electric shock devices emergency doctors use, the implantable defibrillator will deliver an electric jolt to the heart to bring it back into a proper rhythm.
The Jewels require much less surgery than current models. Their smaller size and weight--about the same as a bar of soap--mean they can be implanted in the upper chest with a single incision rather than through the abdominal region, which requires two or more incisions. This eliminates the surgical “tunneling” otherwise needed to pass a wire under the skin from the abdomen to a point near the shoulder, where the wire is inserted in a blood vessel and fed through that vessel into the heart.
The new defibrillators they weigh 4.7 ounces and are 27% smaller than previous models.
Arch Smith, an analyst for the securities firm Piper Jaffray Inc. in Minneapolis, said that neither of Medtronic’s main competitors--Cardiac Pacemakers Inc. or Ventritex Inc.--has a comparable product close to being approved. “Medtronic will have at least a nine-month window of exclusivity,” Smith said.
The worldwide market for treating too-rapid heartbeat--known as tachyarrhythmia--is estimated at $350 million to $400 million and growing.
The Jewel defibrillators were approved outside of the United States in December, 1993.
The company reported that during clinical evaluations of the products, patients spent a mean of three days in the hospital, contrasted with five days for patients receiving abdominal implants. The Jewel devices cost about $22,000 each. That is more than their predecessors, but the company said total costs, including hospital expenses, are 35% less. Hospital costs came to a mean of $13,000, contrasted with $21,000 for previous systems, the company said.
The Jewel approval is the second piece of regulatory good news for Medtronic this year. In January, the FDA approved its Thera line of pacemakers, devices that help speed up hearts that beat too slowly.
Company spokesman Dick Reid said the approvals should allow Medtronic to quickly grab a larger share of the heart care market.
“This gives us the technological lead in devices for treating dangerous heart rhythms,” Reid said.
Several brokerages Monday boosted their predictions for Medtronic profits for 1996. They include Salomon Brothers Inc. in New York and Dain Bosworth in Minneapolis. Bear Stearns & Co. in New York upgraded its investment rating on Medtronic stock.
