![]() There were no device-related complications or major adverse events at 30 days or 6 months, Laird said, noting that there were two major adverse events, both target lesion revascularization, between 6 and 12 months, so 12-month freedom from TLR was 96%. Mean lesion length was 7.4 cm, 88.2% of patients had calcified lesions and 84.9% of patients had lesions in the superficial femoral artery.Īll patients underwent balloon angioplasty, 20% had a drug-coated balloon used and 36% had a stent implanted, Laird said. The primary technical endpoint was ability to cross the target lesion stenosis over the wire.Īll patients were Rutherford class 2, 3 or 4 and the mean ankle-brachial index was 0.57. The primary safety endpoints were freedom from major adverse events at 30 days and freedom from device- and procedure-related events before discharge. ![]() And the device is very effective for calcified lesions because of the short pulse width.”įor the first-in-human trial, the device was used on 50 patients (mean age, 64 years 76% men) at two centers in Poland. Catheter sizes are available to allow both above-the-knee and below-the-knee intervention. the artery’s endothelium, making the risk of perforation lower. It has threefold affinity to lesion-type tissue vs. It has a very short pulse width, 10 nanoseconds, which allows significant energy delivery into the vessel. “This is a small and light solid-state laser with a unique 355-nm wavelength. “There are a number of unique features of this particular laser which offer advantages over the other commercially available laser-based platform,” Laird said during a press conference. Helena, California, and a Cardiology Today’s Intervention Editorial Board Member, presented 12-month data here from one of the two studies the clearance was based on. Laird Jr., MD, medical director of the Adventist Heart and Vascular Institute in St. The system (B-Laser, Eximo Medical) received FDA clearance in October. LAS VEGAS - A laser atherectomy system for treatment of peripheral artery lesions was safe and effective in a first-in-humans study, researchers reported at VIVA 18.
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