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Surmodics announces successful first patient use of Pounce thrombectomy system
Surmodics has announced that J. Michael Bacharach, MD, a vascular interventionalist/cardiologist at North Central Heart, a division of Avera Heart Hospital in Sioux Falls, South Dakota, successfully treated the first patient with the company’s Pounce thrombectomy system. The procedure involved…
Surmodics builds thrombectomy portfolio with acquisition of Vetex Medical
Surmodics recently announced that it has acquired privately-held Vetex Medical Limited, expanding the company’s thrombectomy portfolio with a second Food and Drug Administration (FDA) 510(k)-cleared device, the ReVene thrombectomy catheter. The ReVene mechanical thrombectomy catheter is specifically designed to remove large,…
Boston Scientific recalls Vici SDS and Vici RDS venous stent systems following reports of stent migration
According to a medical device recall notice posted on the Food and Drug Administration (FDA) website, Boston Scientific has recalled its Vici venous stent system (Vici SDS) and Vici RDS venous stent system due to reported instances of stent migration.…
ACC.21: SAFE-PAD finds no increased risk of death with drug-coated devices
Researchers have found no statistically significant difference in mortality between patients treated with drug-coated devices and non-drug-coated devices in the SAFE-PAD study. Eric Secemsky, MD, an interventional cardiologist at Beth Israel Deaconess Medical Center (BIDMC) in Boston, reported this conclusion…
VenoValve: Chronic venous insufficiency device gains brisk double of first US patent, IDE approval
Hancock Jaffe Laboratories recently revealed that the United States Patent and Trademark Office (USPTO) issued the first patent covering the company’s VenoValve. The patent is entitled Implantable Vein Frame and is U.S. patent number 10,959,841. The company recently announced that only…
US surgeons begin commercial use of Gore Excluder conformable AAA endoprosthesis with Active Control system
W. L. Gore & Associates (Gore) today announced the first use of the Food and Drug Administration (FDA)-approved Gore Excluder conformable abdominal aortic aneurysm (AAA) endoprothesis with Active Control system in cases outside of clinical trials. Cases were successfully performed…
FDA grants breakthrough device designation for Zenith fenestrated+ endovascular graft
The Zenith fenestrated+ endovascular graft (ZFEN+) product (Cook Medical) has received breakthrough device designation from the Food and Drug Administration (FDA). This designation is granted for devices that have the potential to provide more effective treatment or diagnosis for life-threatening…
Medtronic recalls unused Valiant Navion thoracic stent graft system
Medtronic has voluntarily issued a global recall of its Valiant Navion thoracic stent graft system and informed physicians to immediately cease use of the device until further notice. In accordance with its commitment to patient safety—and in consultation with independent…
Postmarket study of sirolimus-eluting balloon enrolls first patient
MedAlliance has announced enrollment of the first patient in SUCCESS PTA, its large post-market study with the drug-eluting balloon Selution SLR for the treatment of patients with peripheral arterial disease (PAD). Selution SLR is a novel sirolimus-eluting balloon that provides…
Treo IDE primary endpoint results announced
In the wake of approval by the Food and Drug Administration (FDA) of the Treo abdominal aortic stent-graft system for the treatment of patients with abdominal aortic aneurysms (AAAs), Terumo Aortic has announced the publication of the primary endpoint results…