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Thrombolex: Investigational RESCUE trial yields ‘exciting’ interim data
The prespecified interim analysis of the first 62 evaluable pulmonary embolism (PE) patients enrolled in the investigational RESCUE trial produced positive results, Thrombolex has announced. RESCUE is a prospective multicenter, single-arm pivotal trial evaluating patient outcomes after treatment of acute…
US IDE Aortic Research Consortium ‘pushes the envelope’ on F/BEVAR
The U.S. investigational device exemption (IDE) Aortic Research Consortium has produced the strongest data so far on the use of fenestrated/branched endovascular aneurysm repair (F/BEVAR), Andres Schanzer, MD, professor and chief of vascular surgery at the University of Massachusetts Medical School…
Endologix announces completion of enrollment in TORUS 2 study for PAD in SFA
Endologix has completed enrollment in the TORUS 2 investigational device exemption (IDE) clinical study in the U.S., a press release reports. The TORUS 2 study is a prospective, single-arm trial of 188 patients to evaluate safety and effectiveness of the Torus stent…
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…
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…
FDA grants Nexus aortic arch stent graft system breakthrough designation
Endospan was recently granted breakthrough device designation from the Food and Drug Administration (FDA) for the Nexus aortic arch stent graft system. The FDA’s breakthrough device designation program is intended to provide timely access to medical devices that have the…
Aortic neck dilation after FEVAR leads to little clinical impact, new mid-term study data reveal
MIAMI—Data, gathered in a study on the impact of aortic neck dilation after fenestrated endovascular aortic aneurysm repair (FEVAR), show that the process does indeed occur after the procedure—but with minimal clinical implications. For principal evidence, the researchers pointed out,…