Medical excimer laser developer Ra Medical said it won FDA 510(k) clearance for its Dabra system designed to treat patients with peripheral artery disease. The Carlsbad, Calif.-based company said that the system is designed to destroy arteriosclerotic blockages through the use of radiation ablation, touting the device and associated procedures as cost and time saving. “Dabra’s pivotal […]
Vascular
Ultrasound-drug combo treats pulmonary embolism in less time with fewer drugs
When venous clots break off and travel through a patient’s circulatory system, they can become trapped in the lung and block blood flow. This strains the heart’s ability to pump blood through the lungs and can ultimately lead to heart failure. Traditionally, patients with pulmonary embolisms are treated overnight with systemic infusions of tissue plasminogen […]
Gore wins Japanese regulatory nod for Gore Excluder IBE
W.L. Gore & Associates said today it won Japanese regulatory approval for its Gore Excluder iliac branch endoprosthesis and that the 1st implants of the device had been performed in the region. The Newark, Del.-based company said that the Excluder IBE was the 1st off-the-shelf iliac branch solution approved in the country, and the only device […]
Medtronic launches study of In.Pact Admiral drug-coated balloon in end-stage renal disease
Medtronic (NYSE:MDT) said today that the 1st patient was enrolled in a study of its In.Pact Admiral drug-coated balloon in patients with end-stage renal disease. The FDA approved the investigational device exemption study to evaluate the device as a treatment for failing arteriovenous fistulas in end-stage renal disease patients. Get the full story at our sister […]
Symic Bio raises $30m for peripheral vein graft failure therapy
Symic Bio said yesterday that it raised $30 million in a Series B financing round, led by existing investors and HEDA Ventures. Funds from the round are slated to support the company’s clinical programs, including a drug designed to prevent peripheral vein graft failure, SB-030, and a therapy for pain management of osteoarthritis of the knee, […]
BTG touts Ekos data from pulmonary embolism trial
BTG (LON:BTG) touted data today from the Optalyse PE trial showing that pulmonary embolism can be treated effectively with Ekos over a shorter period and with smaller doses of thrombolytic drugs compared to the current standard. The 101-patient trial randomized participants to receive therapeutic anticoagulation and Ekos acoustic pulse thrombolysis therapy at different doses for different lengths […]
EuroPCR Roundup: Medtronic’s Resolute Onyx meets primary endpoint in small-vessel trial
Medtronic‘s (NYSE:MDT) Resolute Onyx 2.0mm drug-eluting stent met its primary endpoint of target lesion failure at 1 year for the treatment of coronary artery disease in extra-small vessels, according to data from the Resolute Onyx 2.0mm trial. The trial enrolled 101 patients with extra-small vessel sizes ranging from 2 millimeters to 2.25 millimeters. Patients treated with […]
Alucent wins FDA nod for trial of novel drug-device PVD treatment
Alucent Medical said today that it won FDA approval to begin Phase I clinical studies of its Natural Vascular Scaffolding, a novel combination drug-device therapy for the treatment of peripheral vascular disease. Percutaneous balloon angioplasty, a process that involves drug-coated balloons and metal stents, is the traditional standard of care for peripheral vascular disease. These […]
Shockwave wins CE Mark for coronary Lithoplasty device
Shockwave Medical said today that it won CE Mark approval in the European Union for its coronary Lithoplasty system. The therapy is designed to treat calcified coronary artery blockages with lithotripsy – sonic pressure waves that are traditionally used to treat patients with kidney stones. The approval was supported by clinical data from the Disrupt […]
New Zealand OKs CE Mark trial for Medeon Biodesign’s XPro large-bore vascular closure device
Medeon Biodesign said today it won approval from the New Zealand Ministry of Health’s Health and Disability Ethics Committees to initiate a clinical trial of its XPro suture-mediated vascular closure device as it seeks CE Mark approval. The study will examine the safety and effectiveness of the XPro System in facilitating hemostasis in patients undergoing percutaneous […]
GE Healthcare wins FDA nod for Visipaque coronary CT angiography injection
GE Healthcare (NYSE:GE) said today that it won an indication approval from the FDA for its Visipaque injection imaging agent. The 320 milligram iodine per milliliter injection is an iso-osmolar agent that the federal watchdog approved for use in coronary computed tomography angiography. The new indication allows doctors to image coronary arteries of patients to help […]