CHICAGO/NEW YORK (Reuters) - A potential breakthrough heart valve from Edwards Lifesciences Corp that can spare patients from chest-cracking, open heart surgery will take center stage at one of the year's most important heart meetings this weekend.
Tens of thousands of cardiologists and researchers will gather for the American College of Cardiology Scientific Sessions in New Orleans, a town famous for its artery-clogging cuisine, to discuss the latest advances in heart devices, drugs and procedures from April 2-5.
The most eagerly anticipated study being presented at the meeting will compare death rates in high-risk patients from open heart valve replacement surgery to death rates for those who get the Edwards Sapien system for transcatheter aortic valve implantation, or TAVI.
Doctors have said there may be more than 100,000 patients in the United States whose valve disease is either not being addressed, or who cannot tolerate open heart surgery, who may eventually be eligible for the TAVI approach.
The Sapien valve is threaded through the arteries to the heart via a catheter inserted either in the femoral artery in the groin or through a small incision between the rib cage, avoiding the need for open-heart surgery in which the ribs are sawed open, the heart is stopped and a new valve is sewn in.
Expectations are running high for the Edwards system, but doctors will also be looking for evidence of whether it raises the risk for stroke.
Results from the study called Partner will be used to seek U.S. approval, expected later this year, for the Edwards system that will eventually compete with a similar system being developed by Medtronic Inc's CoreValve unit.
DEVICE-HEAVY MEETING
Pharmaceutical companies have increasingly turned their attention to cancer, autoimmune diseases and specialty drugs, since there is already a flood of blood pressure and cholesterol treatments on the market.
As a result, there are fewer important drug studies at ACC this year than perhaps at any previous meeting.
Other high-profile studies at the device-heavy meeting will look at the safety and effectiveness of the next generation of heart stents being tested by Medtronic, Boston Scientific Corp and Abbott Laboratories.
Abbott will also have two-year data on its MitraClip to demonstrate the durability of its minimally invasive technique for repairing leaky heart valves.
One area of remaining hot competition in new drug development is blood thinners that aim to replace warfarin and may become alternatives to other drugs used to prevent blood clots and strokes.
Xarelto, from Bayer and Johnson & Johnson, will be featured in a trial that compares the pill's ability to prevent blood clots in the leg and lung that occur in hospitalized patients with that of the widely used injectable Sanofi-Aventis drug Lovenox.
But Edwards is expected to steal the spotlight with cardiologists.
In September, the company presented data from another arm of the study that showed transcatheter valve recipients who were too elderly and sick to endure surgery fared far better than those who received standard drug treatment.
The data being presented at ACC is intended to show that the transcatheter approach in patients with aortic stenosis is as good as surgery in high-risk patients deemed able to endure surgery.
"Positive data would significantly expand the patient population ... and support both approval of, and a broader label for the Sapien valve in the United States," William Blair analyst Ben Andrew said in a research note.
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