Today marks the last demos in Paris as EuroPCR comes to a close and the world's cardiovascular device companies wrap up their pitches, implantations and data dumps. Here's a roundup of the biggest news from Day Four of a busy week of stenting and elution. Don't miss our coverage of Day One, Day Two and Day Three.
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Covidien's ($COV) new drug-coated balloon for peripheral artery disease performed well at 12 months, the company said, reporting 87% primary patency in treated arteries and a 10% rate of adverse events, with no deaths, no amputations and 5 target lesion revascularizations in a 50-patient study. The device is a paclitaxel-coated angioplasty balloon inserted into leg arteries to treat blockages, and, with its first-in-human study done, Covidien is planning more large-scale trials to validate the technology. Covidien acquired the balloon in January with its buyout of CV Ingenuity, and while the company didn't disclose the sale price, it did say it would increase R&D spending by $20 million in the first half of 2013 and $30 million next year to prepare the device for regulatory scrutiny. Results |
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Tryton Medical is looking to expand sales of the Tryton Side Branch Stent, announcing a new 150-patient trial helmed by the Nordic-Baltic Bifurcation Study Group. The study will examine the implant's effectiveness when paired with a drug-eluting stent, using optical coherence tomography imaging to confirm Tryton's already strong results in patients with bifurcation lesions. The CE marked device is already on the market in Europe, Russia and the Middle East, and Tryton is in the midst of large-scale pivotal trial aimed to secure FDA approval. Earlier this year, Tryton locked down $24 million in equity financing, money the company will use to carry the Tryton Side Branch Stent to a U.S. launch. More |
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The privately held Kona Medical unveiled 6-month results for its Surround Sound renal denervation system, reporting that patients experienced a 29 mmHg drop in systolic blood pressure and endured no device-related serious adverse events. Those results, while early, put Kona's device in the same ballpark as offerings from the likes of Medtronic ($MDT) and St. Jude Medical ($STJ). And, unlike the catheter-based renal denervation systems on the market, Surround Sound uses external ultrasound energy to deaden arterial nerves, a method Kona said could expand access to the treatment and lower costs. Back in December, Kona closed a $40 million Series C to support Surround Sound, and the company's progress has an enticing precedent: A year ago, Vessix Vascular was a private devicemaker touting its renal denervation data, and now, $425 million later, it's a subsidiary of Boston Scientific ($BSX). Results |
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Elixir Medical's DESyne drug-eluting stent excelled in two-year results, the company said, posting a 2.7% rate of major adverse cardiac events and a 1.8% rate of target lesion revascularization, beating the the 3.2% rate of Medtronic's Endeavor, all with no reported stent thrombosis. The stent, which emits novolimus to treat coronary artery disease, won its CE mark in 2011 and is on the market overseas. This month, the FDA gave Elixir its blessing to kick off a 2,051-patient pivotal trial, comparing DESyne to Medtronic's Resolute stent with an eye on U.S. approval. Elixir also recently snagged a CE mark for DESolve, the company's bioresorbable stent for CAD, and Elixir reported strong results for that device earlier at EuroPCR. Results |
