Cardiovascular device developer BioStable Science & Engineering said today it began a limited launch of its HAART 300 aortic annuloplasty device, with the 1st commercial procedure being performed at the West Virginia University Heart and Vascular Institute. The 1st procedure was performed by Dr. Lawrence Wei, Dr. Vinay Badhwar and Dr. J. Rankin, according to the Austin, […]
Vascular
BTG touts digital patient engagement platform with TheraSphere treatment
BTG (LON:BTG) touted data last week from a pilot study of its digital patient engagement platform IO Loop in patients with primary hepatocellular carcinoma undergoing treatment with the company’s TheraSphere transarterial radioembolization therapy. The study found that patients experienced sustained quality of life up to 3 months after treatment. The company called the study of […]
MassDevice Q&A: Claret Medical’s Azin Parhizgar on trying to make TAVR safer
Cerebral protection developer Claret Medical recently won FDA de novo clearance for its Sentinel device designed to trap blood clots and prevent stroke during heart valve replacement procedures. The Sentinel uses a pair of filters, 1 in the brachiocephalic artery another in the left common carotid artery, to trap debris released during transcatheter aortic valve replacement that could cause […]
Amaranth Medical looks to recapture the potential of bioresorbable scaffolds
Dr. Antonio Colombo had finished his presentation of 9-month data for Amaranth Medical‘s Aptitude sirolimus-eluting bioresorbable scaffold when an audience member asked about adverse events. He told the EuroPCR attendee that they hadn’t seen any adverse events related to the device during the trial – and that’s unusual. Bioresorbable scaffolds, like Abbott‘s (NYSE:ABT) Absorb, have been […]
OrbusNeich wins FDA nod for Sapphire II Pro, NC Plus balloon dilation caths
OrbusNeich said today it won FDA 510(k) clearance for its Sapphire II Pro and Sapphire NC Plus balloon dilation catheters and launched the devices in the US. The Hong Kong-based company’s Sapphire II Pro features a sub-zero tapered tip and an ultra-low profile for entry through tight lesions, as well as a proprietary XR balloon for crossability […]
Endologix touts low rate of endoleaks, mortality in 2-year Nellix study results
Endologix (NSDQ:ELGX) today announced the presentation of 2-year data from the EVAS Forward IDE trial of its Nellix stent graft for repairing abdominal aortic aneurysms, touting a high rate of freedom from endoleaks, ruptures and mortalities. Results from the trial were presented by study principal investigator Dr. Jeffrey Carpenter of New Jersey’s Cooper Medical Schoo and […]
Endologix touts 30-day data from study of Ovation stent graft in women
Endologix (NSDQ:ELGX) touted 30-day data today from a trial evaluating its Ovation abdominal stent graft system in women. The Lucy trial showed that at least 28% more women became eligible for minimally-invasive endovascular aneurysm repair when using the Ovation stent graft. The study is the 1st to assess endovascular aneurysm repair outcomes in women, according to […]
Avinger touts 2-year Pantheris study data
Avinger today released data from the pivotal vision study of its Pantheris system, touting high survivability and freedom from target lesion revascularization in patients treated with the system. The 89-patient Vision study aimed to evaluate the safety and effectiveness of its Pantheris directional atherectomy system which uses real-time intravascular imaging to remove plaque from diseased […]
Vascular graft dev Somahlution launches EU registry trial of DuraGraft
Vascular graft developer Somahlution said today it launched the DuraGraft European Registry clinical trial of its DuraGraft device, enrolling the 1st patient in the study. In the registry study, investigators will evaluate the Jupiter, Fla.-based company’s DuraGraft, a vascular graft treatment designed to reduce the burden of ischemia reperfusion injuries, during use in coronary artery bypass […]
FDA clears Ra Medical’s Dabra arteriosclerosis laser
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 […]
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 […]