Edwards’ Sapien Update: Positive Trial Results Announced
For all of you following the advancements and latest technology of heart valve replacement, here is some encouraging news specific to minimally invasive surgery using a catheter…
According to Forbes, shares of Edwards Lifesciences, the largest heart valve manufacturer, rose 10% yesterday after the company announced positive results from two recent studies of its newest bovine valve replacement device, known as the Sapien.
“Were the results of the study that good?” you may be wondering.
Well… Edwards said its latest trial saw a 94% survival rate from 30-day results of a European study of its Edwards Sapien transcatheter aortic heart valve. The study used data collected after the valve was approved for commercial use in Europe late last year, spokeswoman Sarah Huoh said.
A second study using data collected both before and after the European approval showed a 92% survival rate at 30 days and 94% at six months.
By comparison, the survival rate for very ill patients treated with open heart surgery would have been about 75% after 30 days, the company said in a statement.
Although there have been mixed feeling about the risks of the Sapien heart valve, I continue to believe this technology will evolve to become an option for more patients in the coming years - especially those with elevated risk factors.
Keep on tickin!
About The Author: Adam Pick is a double, heart valve surgery patient and author of The Patient’s Guide To Heart Valve Surgery, a unique book which integrates the clinical facts of heart valve surgery with the personal experiences of an actual heart valve surgery patient. To learn more about Adam and his heart valve surgery book, click here.
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October 14th, 2008 at 2:38 pm
So a big question for those of us awaiting our first aortic valve replacement: if the trials continue to show excellent results, how long might it typically take until this procedure gains Federal approval and the average person can look forward to this being the first-choice procedure for a normal aortic valve replacement? Two years? Five? Ten?
Thanks, Adam, for the book and the great updates.