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FDA announces plans to address medical device shortage risks
The Food and Drug Administration (FDA) has issued a statement outlining measures to enhance protections against medical device shortages. According to Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health (CDRH), supply chain disruptions—often caused by natural…
When RCTs are essential for novel vascular access device regulation
As part of a 2024 VEITHsymposium (New York City; Nov. 19–23) debate, Robert E Lee, MD, a medical officer recently retired from the Food and Drug Administration (FDA), presented an argument in favor of when the use of randomized controlled…
Survey of off-label treatment of complex repair pinpoints factors behind underreported outcomes data
The potential for cost and time to be key factors in low levels of outcomes data reporting emerged during a national survey of the off-label use of approved endovascular devices for complex aortic aneurysm repair. Grayson S. Pitcher, MD, an…
Acellular tissue-engineered vessel granted FDA Regenerative Medicine Advanced Therapy designation for advanced PAD
Humacyte recently announced it has been granted Regenerative Medicine Advanced Therapy (RMAT) designation from the US Food and Drug Administration (FDA) for its investigational acellular tissue-engineered vessel (ATEV), designed to treat patients with advanced peripheral arterial disease (PAD). This RMAT…
Gore announces first commercial implant of Gore Tag thoracic branch endoprosthesis in Canada
Gore has announced the first commercial use of the Gore Tag thoracic branch endoprosthesis (TBE) in Canada. The news came as Canadian government health authority Health Canada approved the first-of-its-kind endovascular device, which is indicated to treat lesions of the…
Vascular community has a role to play in ensuring safety of aortic devices
Physician-sponsored Investigational Device Exemption (IDE) trials have an important role to play in the continued development and refinement of aortic endovascular devices, attendees of a panel session on aortic device regulation heard yesterday. The session, taking place Wednesday lunchtime, set…
Analysis will kickstart conversation on F/BEVAR outcomes
New data presented during Friday’s Plenary Session 6 (10–11 a.m. in the West Building, Skyline Ballroom) will shed light on trends in the adoption of fenestrated and branched endovascular aortic repair (F/BEVAR) outside of Food and Drug Administration (FDA) Investigational…
Getinge and Cook Medical enter US commercial distribution agreement for iCast covered stent
Getinge and Cook Medical today announced an exclusive sales and distribution agreement for the iCast covered stent system, which recently received Food and Drug Administration (FDA) premarket approval for the treatment of symptomatic iliac arterial occlusive disease. Cook Medical will…
FORS-powered LumiGuide 3D imaging technology is rolled out at specialized centers in U.S. and Europe
Andres Schanzer, MD, has hailed it “one of the most exciting changes” seen in imaging during the course of his career. Philips’ LumiGuide “human GPS” technology—which uses light reflected along an optical fiber inside a guidewire to generate three-dimensional (3D),…
Breakthrough Device designation granted for Efemoral scaffold system designed to treat CLTI
Efemoral Medical has announced the granting of Food and Drug Administration (FDA) Breakthrough Device status for its novel Efemoral vascular scaffold system (EVSS) designed to treat de novo or restenotic lesions of the infrapopliteal arteries in patients with chronic limb-threatening ischemia (CLTI).…