This is "probably the hottest area of interventional cardiology," said Dr. Martin B. Leon, founder and chairman emeritus of the Cardiovascular Research Foundation, which runs the TCT conference. Leon is one of the main investigators for a trial that Edwards Lifesciences Corp. (EW) is running to generate evidence for potential U.S. approval of its "Sapien" heart valves, now on sale in Europe.
Data from Edwards' study won't be available until next year and, for now, there isn't much clinical research on these new valves to discuss. Nevertheless, like last year, the devices will be "a major focus of the conference program throughout the week," JPMorgan analyst Michael Weinstein observed. There will be some updates on European studies involving the Edwards devices and plenty of valve-related forums.
Drug-coated stents, which prop open arteries and use medication to combat scar tissue that can trigger repeat procedures, are a major tool for interventional cardiologists currently and represent about a $4billion global market. But as Boston Scientific Chief Executive Ray Elliott noted at a recent analyst conference, this is also a "flattish" market.
The transcatheter-valve market is small, on pace for roughly $200 million in annual sales - all outside the U.S. But manufacturers see a multibillion-dollar potential as devices reach more markets and usage increases, and the market's infant state creates the opportunity for rapid growth. Edwards, for example, expects more than $100 million in sales of its "Sapien" transcatheter valve this year, which would about double the device's 2008 tally.
Sapien helped land Edwards on a short list of medical-device companies that improved their stock price last year, and it has risen another 22% this year.
Some large medical-devices companies want in on the action. Medtronic, for example, became Edwards' top competitor when it spent more than $1 billion earlier this year on two privately held makers of transcatheter valves, including a company already competing with Edwards in Europe.
Abbott, meantime, announced plans last week to spend up to $410 million on privately held Evalve, which makes a product used in minimally invasive valve repair. Johnson & Johnson and St. Jude Medical Inc. have also expressed interest in the market.
A central idea behind with these devices is that traditional chest-opening heart surgery for valve replacement is too taxing for many elderly and frail patients. The Edwards and Medtronic devices can be threaded into place through arteries, and the Edwards valve can also be implanted through an incision between the ribs - Medtronic is working on that delivery method.
The Edwards and Medtronic devices replace the heart's aortic valve, which is the exit door for the heart's main pumping chamber. The system Abbott is buying repairs the mitral valve, which leads into that chamber.
On the stent front, the top study at TCT may be the "Spirit IV" trial sponsored by Abbott and due Wednesday. It's a big study matching up Abbott's Xience stent, which became a market-leading device based on prior strong study data, and which is also sold by Boston Scientific in a profit-sharing deal, against older Taxus Express-brand stents from Boston Scientific.
Medtronic, which has struggled to grab a bigger stake in the U.S. drug-coated stent market amid Abbott's rise, will have three-year data from the "Endeavor IV" trial that helped the company's Endeavor stent gain access to the U.S. last year. [rc]
Jon Kamp, Dow Jones News
jon.kamp@dowjones.com
Copyright ©2009 Dow Jones & Company, Inc.
Remember ME - You Me and Dementia
September 18, 2009
USA: Heart Valves To Take Spotlight At Major Cardiology Conference
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NEW YORK, NY / Wall Street Journal / Business / September 18, 2009
By Jon Kamp of Dow Jones Newswires
A yearly cardiology conference coming next week has long provided a big stage for heart stents, but the spotlight is shifting to newer devices that hold more promise for growth: Heart valves that don't require major surgery.
Major studies set for release at this year's Transcatheter Cardiovascular Therapeutics event in San Francisco will still involve drug-coated stents from Abbott Laboratories, Boston Scientific Corp. and Medtronic Inc. The stent market is struggling to grow, however, while what are known as transcatheter valves are garnering increasing attention from both big device makers and interventional cardiologists who perform catheter-based heart procedures.
This is "probably the hottest area of interventional cardiology," said Dr. Martin B. Leon, founder and chairman emeritus of the Cardiovascular Research Foundation, which runs the TCT conference. Leon is one of the main investigators for a trial that Edwards Lifesciences Corp. (EW) is running to generate evidence for potential U.S. approval of its "Sapien" heart valves, now on sale in Europe.
Data from Edwards' study won't be available until next year and, for now, there isn't much clinical research on these new valves to discuss. Nevertheless, like last year, the devices will be "a major focus of the conference program throughout the week," JPMorgan analyst Michael Weinstein observed. There will be some updates on European studies involving the Edwards devices and plenty of valve-related forums.
Drug-coated stents, which prop open arteries and use medication to combat scar tissue that can trigger repeat procedures, are a major tool for interventional cardiologists currently and represent about a $4billion global market. But as Boston Scientific Chief Executive Ray Elliott noted at a recent analyst conference, this is also a "flattish" market.
The transcatheter-valve market is small, on pace for roughly $200 million in annual sales - all outside the U.S. But manufacturers see a multibillion-dollar potential as devices reach more markets and usage increases, and the market's infant state creates the opportunity for rapid growth. Edwards, for example, expects more than $100 million in sales of its "Sapien" transcatheter valve this year, which would about double the device's 2008 tally.
Sapien helped land Edwards on a short list of medical-device companies that improved their stock price last year, and it has risen another 22% this year.
Some large medical-devices companies want in on the action. Medtronic, for example, became Edwards' top competitor when it spent more than $1 billion earlier this year on two privately held makers of transcatheter valves, including a company already competing with Edwards in Europe.
Abbott, meantime, announced plans last week to spend up to $410 million on privately held Evalve, which makes a product used in minimally invasive valve repair. Johnson & Johnson and St. Jude Medical Inc. have also expressed interest in the market.
A central idea behind with these devices is that traditional chest-opening heart surgery for valve replacement is too taxing for many elderly and frail patients. The Edwards and Medtronic devices can be threaded into place through arteries, and the Edwards valve can also be implanted through an incision between the ribs - Medtronic is working on that delivery method.
The Edwards and Medtronic devices replace the heart's aortic valve, which is the exit door for the heart's main pumping chamber. The system Abbott is buying repairs the mitral valve, which leads into that chamber.
On the stent front, the top study at TCT may be the "Spirit IV" trial sponsored by Abbott and due Wednesday. It's a big study matching up Abbott's Xience stent, which became a market-leading device based on prior strong study data, and which is also sold by Boston Scientific in a profit-sharing deal, against older Taxus Express-brand stents from Boston Scientific.
Medtronic, which has struggled to grab a bigger stake in the U.S. drug-coated stent market amid Abbott's rise, will have three-year data from the "Endeavor IV" trial that helped the company's Endeavor stent gain access to the U.S. last year. [rc]
Jon Kamp, Dow Jones News
jon.kamp@dowjones.com
Copyright ©2009 Dow Jones & Company, Inc.
This is "probably the hottest area of interventional cardiology," said Dr. Martin B. Leon, founder and chairman emeritus of the Cardiovascular Research Foundation, which runs the TCT conference. Leon is one of the main investigators for a trial that Edwards Lifesciences Corp. (EW) is running to generate evidence for potential U.S. approval of its "Sapien" heart valves, now on sale in Europe.
Data from Edwards' study won't be available until next year and, for now, there isn't much clinical research on these new valves to discuss. Nevertheless, like last year, the devices will be "a major focus of the conference program throughout the week," JPMorgan analyst Michael Weinstein observed. There will be some updates on European studies involving the Edwards devices and plenty of valve-related forums.
Drug-coated stents, which prop open arteries and use medication to combat scar tissue that can trigger repeat procedures, are a major tool for interventional cardiologists currently and represent about a $4billion global market. But as Boston Scientific Chief Executive Ray Elliott noted at a recent analyst conference, this is also a "flattish" market.
The transcatheter-valve market is small, on pace for roughly $200 million in annual sales - all outside the U.S. But manufacturers see a multibillion-dollar potential as devices reach more markets and usage increases, and the market's infant state creates the opportunity for rapid growth. Edwards, for example, expects more than $100 million in sales of its "Sapien" transcatheter valve this year, which would about double the device's 2008 tally.
Sapien helped land Edwards on a short list of medical-device companies that improved their stock price last year, and it has risen another 22% this year.
Some large medical-devices companies want in on the action. Medtronic, for example, became Edwards' top competitor when it spent more than $1 billion earlier this year on two privately held makers of transcatheter valves, including a company already competing with Edwards in Europe.
Abbott, meantime, announced plans last week to spend up to $410 million on privately held Evalve, which makes a product used in minimally invasive valve repair. Johnson & Johnson and St. Jude Medical Inc. have also expressed interest in the market.
A central idea behind with these devices is that traditional chest-opening heart surgery for valve replacement is too taxing for many elderly and frail patients. The Edwards and Medtronic devices can be threaded into place through arteries, and the Edwards valve can also be implanted through an incision between the ribs - Medtronic is working on that delivery method.
The Edwards and Medtronic devices replace the heart's aortic valve, which is the exit door for the heart's main pumping chamber. The system Abbott is buying repairs the mitral valve, which leads into that chamber.
On the stent front, the top study at TCT may be the "Spirit IV" trial sponsored by Abbott and due Wednesday. It's a big study matching up Abbott's Xience stent, which became a market-leading device based on prior strong study data, and which is also sold by Boston Scientific in a profit-sharing deal, against older Taxus Express-brand stents from Boston Scientific.
Medtronic, which has struggled to grab a bigger stake in the U.S. drug-coated stent market amid Abbott's rise, will have three-year data from the "Endeavor IV" trial that helped the company's Endeavor stent gain access to the U.S. last year. [rc]
Jon Kamp, Dow Jones News
jon.kamp@dowjones.com
Copyright ©2009 Dow Jones & Company, Inc.