Heading into next week’s Transcatheter Cardiovascular Therapies 2012 conference in Miami, the Natick, Mass.-based medical device company’s global chief medical officer told us that BSX is planning to highlight several technologies at the show.
A single-electrode renal denervation system will go into its 1st human trials over "the next few months," Dawkins told us. Boston Scientific is also working on a double-electrode device, he added.
"We’re looking at being able to reduce the time it takes to do an ablation," Dawkins said.
Renal denervation is a hot space these days, with both St. Jude Medical (NYSE:STJ) and Medtronic (NYSE:MDT) vying for the multi-billion-dollar market. Incoming BSX CEO Michael Mahoney said in June that Boston Scientific would look for CE Mark approval and European commercialization in 2013, pegging the renal denervation market at around $3 billion worldwide by 2020.
Boston Scientific has "a number of organic programs currently taking place to enter the hypertension market," Mahoney said, and the company expects U.S. trials in 2014.
At TCT next week, Dawkins said the company will pay particular attention to 3 devices.
"We are a company that grows by acquisition and there are 3 different technologies we’ve acquired that we’ll be highlighting," he said.
Dawkins told us that BSX will spotlight its Watchman device, which won CE Mark approval in August. In May, research presented at the HRS 2012 conference showed that the device is as effective as the anti-coagulant drug Warfarin in preventing stroke in high-risk atrial fibrillation patients. The device is designed to trap blood clots in the heart.
"It’s a very useful and unique device for patients who can’t go on anti-coagulants," he said, noting that a pivotal trial for the U.S. is done. Boston Scientific expects FDA approval during the 1st half of 2013, Dawkins said.
The ASA Plavix trial showed a 77% reduction in risk of stroke versus patients continuing on oral anti-coagulants like Warfarin, he said. There are 6 studies underway examining about 2,000 patients for long-term followup, Dawkins said.
Boston Scientific will also focus on the Lotus transcatheter aortic valve implant it bought in 2011 with the $450 million buyout of Sadra Medical. The device is designed to minimize valve leakage post-implantation. BSX enrolled the 1st patient in its Reprise II trial of the device last week, ahead of a bid for CE Mark and other international approvals. The earlier Reprise I study found no moderate or severe leakage after valve placement or at patient discharge from the hospital.
CE Mark approval for the Lotus device is also expected during the 1st half of 2013, Dawkins told us, noting that the Lotus is a true 2nd-generation TAVI solution that’s repositionable, retrievable and employs a unique anti-paravalvular leakage "adaptive seal."
Finally, Dawkins cited the chronic total occlusion technology BSX picked up last month when it bought BridgePoint Medical for an undisclosed amount. The BridgePoint device is designed to allow cardiologists to treat coronary chronic total occlusions by threading a catheter guidewire across the blockage. Its CrossBoss CTO-crossing catheter and Stingray CTO re-entry system is cleared for sale in the U.S. and Europe, Dawkins said.
"Straightaway off the acquisition we’ll be able to generate revenues," he told us.
Problems with a so-called "stent shrinkage" issue captured much attention after last year’s TCT. Dawkins said the company’s new Synergy stent, its first with an absorbable biopolymer coating, is made of platinum-chromium.
"Platinum allows thinner struts and it’s also very radiopaque," he said. Asked about the crumpling issue, Dawkins said the problem is rare now as physicians have adapted to the newer, thinner strut design.
"We now understand the mechanism better," he said. "This phenomenon occurs very infrequently. It’s very uncommon."
The Evolve II pivotal trial of the device is slated to launch within "the next few weeks," Dawkins said, with the Evolve Short DAPT trial slated for the 1st half of 2013. That study will examine 8,000-10,000 patients, comparing dual-antiplatelet therapy for 3 months post-stenting will a full year of the anti-clotting drug therapy..
"This will allow us to then explore shortening the need for DAPT," he said.
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