On March 1, Boston Scientific Corp.’s Agent drug-coated balloon (DCB) became the first DCB to gain U.S. FDA approval for treatment of in-stent restenosis in patients with coronary artery disease. With more than 100,000 patients already treated in Europe, Latin America and Japan, it’s no secret Agent provides significant benefit compared to balloon angioplasty or drug-eluting stents (DES) for the approximately 10% of patients with coronary stents who experience subsequent narrowing of the treated vessel.
Medalliance SA reported completion of patient enrollment in the SAVE clinical trial with its Selution SLR 018 drug-eluting balloon. Eighty-four subjects have been recruited for this prospective multi-center, single-blinded, randomized controlled trial. These patients received either standard high-pressure balloon angioplasty followed by local application of Selution SLR, or else high-pressure balloon angioplasty with no further lesion treatment.
Endologix LLC reported 12-month results from the second of two studies of a fully percutaneous, transmural arterial bypass therapy for treating peripheral arterial disease. Presented at this month's annual Vascular Interventional Advances Conference in Las Vegas, the Detour-2 study revealed technical success in 100% of treated patients using the system which also surpassed a 30-day, major adverse event rate of just 7%.”
After three years of clinical research, Royal Philips NV said its Tack (4-F) endovascular system has shown promising results for arterial dissection repair following balloon angioplasty in patients with critical limb ischemia and infrapopliteal arterial occlusive disease. The data was collected from a 36-month follow-up in the Tack Optimized Balloon Angioplasty (TOBA) II below-the-knee clinical trial.
HONG KONG – Singapore-based Genesis Medtech International Pte. Ltd. has acquired the Chocolate Touch drug-coated balloon angioplasty asset from Pleasanton, Calif.-based Trireme Medical LLC. The drug-device technology asset in question is designed with the intention of providing a safer and more effective treatment for patients suffering from peripheral vascular disease, compared to traditional balloon angioplasty.
