MIAMI BEACH — There are a lot of appetizing data being served this week at the Transcatheter Cardiovascular Thereapeutics (TCT) meeting in Miami, but one of the main courses is clearly transcatheter aortic valve implant (TAVI), also known as transcatheter aortic valve replacement (TAVR). TCT, sponsored by the Cardiovascular Research Foundation (New York), dedicated a sizeable portion of the meeting to the current data on TAVI/TAVR featuring Edwards Lifesciences (Irvine, California) at the head of the table with its Sapien valve, with several other companies wrestling for a slice of the TAVI pie.
InSightec (Tirat Carmel, Israel) reported that the FDA has approved its Exablate MRI-guided focused ultrasound as a therapy to treat pain from bone metastases in patients who do not respond or cannot undergo radiation treatment for their pain.
In the words of a leading interventional gastroenterologist, Sohail Shaikh, MD, bariatric surgery is "awesome" when it works but when it doesn't work it can lead to painful and dangerous complications, such as fistulas, ulcers, or leakage. Regaining weight is another post-surgical concern of which roughly 25% to 30% of the patients who undergo bariatric surgery have to contend.
Covidien (Dublin, Ireland) recently reported final 12-month results from its DEFINITIVE LE study (determination of effectiveness of SilverHawk/TurboHawk peripheral plaque excision systems for the treatment of infrainguinal vessels/lower extremities) study. With about 800 patients enrolled at 47 centers in the U.S. and Europe, the study is the largest peripheral atherectomy study conducted with independent physician review of the outcomes, Covidien noted.
Stryker (Kalamazoo, Michigan) said it has agreed to acquire privately-held Surpass Medical (Tel Aviv, Isreal), a company based out of Israel with manufacturing and R&D in Miramar, Florida, in an all cash transaction for $100 million and up to an additional $35 million in milestone payments.
With Transcatheter Cardiovascular Therapeutics (TCT) meeting quickly approaching next week, one device industry experts have on the radar is the Absorb drug eluting bioresorbable vascular scaffold (BVS) from Abbott (Abbott Park, Illinois). The device, which is for the treatment of coronary artery disease and has been a decade in the making, recently became available across Europe and parts of Asia Pacific and Latin America (Medical Device Daily, Sept. 26, 2012).
Edwards Lifesciences (Irvine, California) reported unexpectedly weak third quarter sales, but both the company and analysts say near-term catalysts should boost fourth quarter and 2013 sales.