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To: GREENLAW4-7 who wrote (33660)	8/29/2001 8:36:55 AM
From: Jim Spitz	Read Replies (1) \| Respond to of 37746

Medtronic heart-failure device approved for U.S. sale Terry Fiedler Star Tribune Published 08/29/01 Medtronic CEO Art Collins is calling the imminent U.S. rollout of its InSync device for treating heart failure the company's 'largest new product introduction ever,' with estimated first-year sales of 'well north of $100 million.' The Fridley-based company announced Tuesday that it had received Food and Drug Administration approval to market the InSync domestically. Collins said it should be on the market by the end of next week. The InSync has been sold in Europe for three years. Analysts have said the market for devices that treat heart-failure could reach $1 billion within three years. Beyond that, Collins said, 'we look at it as a $2 billion market and we expect to be the clear leader.' For the foreseeable future, Medtronic will be the only company in the U.S. market. A panel of outside experts recommended in July that the FDA approve Medtronic's InSync device for domestic sale. The panel rejected plans for a similar device made by Medtronic's closest rival, Guidant Corp., which has its cardiac rhythm management group headquarters in Arden Hills. Guidant will submit a revised proposal before Sept. 6. U.S. Piper Jaffray analyst Thomas Gunderson noted that Medtronic won FDA approval four to six weeks earlier than most people had expected. He added that new U.S. sales would be in addition to the $40 million annually the company sells overseas and in trials. Fred McCoy, president of Guidant's cardiac rhythm management group, called Medtronic's FDA approval 'excellent news for the ... people struggling with congestive heart failure. We look forward to joining that marketplace.' He would not speculate on how soon that might happen. 'This is a very significant market and it's significant that Medtronic is in the market first,' said A.G. Edwards analyst Jan Wald. 'But the market is big enough that two or three players will do well.' Wald estimated that Little Canada-based St. Jude Medical would have a heart-failure product on the U.S. market in about a year and that Guidant would get approval for its Contak CD, which includes a defibrillator, by next summer. Heart failure, also called congestive heart failure, is a condition in which a damaged or overworked heart can't pump enough blood. Heart attacks, high-blood pressure and valve disease are among the leading precursors to heart disease. Its symptoms include fatigue, chest congestion and the buildup of fluid in the abdomen, feet or legs. Nearly 5 million Americans have the condition and each year about 500,000 new cases are detected. Heart failure is the leading cause of hospital admissions in the country and it's estimated that heart failure contributes to or causes 250,000 deaths a year. Medtronic projects that about 650,000 of the 5 million Americans with the condition are candidates for its InSync device, which uses electrical current to help the heart pump more efficiently. The InSync costs about $8,500 and is surgically implanted in much the same way as a pacemaker. The half-dollar sized device is used in combination with drugs, which previously were the only treatment. Clinical trials showed that the device helped increase exercise capacity and the quality of life for some of the sickest heart-failure patients. Wald said the market will 'take shape kind of slowly' because doctors who treat the condition will have to refer patients to another doctor for an implant. He added the surgery is relatively lengthy. A defibrillator implant might take 35 to 40 minutes, while an InSync implant might take more than two hours. Still, Collins said, heart-failure patients who could use the device are 'very sick and in a mode where their condition is deteriorating. They will take a proactive approach to find out if the therapy benefits them.' -- Terry Fiedler is at tfiedler@startribune.com . © Copyright 2001 Star Tribune. All rights reserved.