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Bryan Kay
Shape Memory Medical announces midway milestone in AAA-SHAPE randomised controlled pivotal trial
Shape Memory Medical has reached 50 per cent enrolment in its ongoing AAA-SHAPE pivotal trial, the company announced last week. AAA-SHAPE is a prospective, multicenter, randomized, open-label trial to determine safety and effectiveness of the Impede-FX RapidFill device to improve…
Medtronic’s Endurant receives FDA labelling approval to remove rAAA treatment warning
Medtronic recently announced it has received Food and Drug Administration (FDA) labelling approval for the Endurant stent graft system, by adding ruptured abdominal aortic aneurysm (rAAA) clinical evidence and removing the rAAA treatment warning. A press release notes that this…
Sheahan takes over as Vascular Surgery Board chair
Malachi Sheahan III, MD, chair of the Department of Surgery and chief of vascular surgery at Louisiana State University in New Orleans, is the new chair of the Vascular Surgery Board (VSB) of the American Board of Surgery (ABS). Sheahan…
Medtronic fully launches Neuroguard IEP system
Medtronic has announced the full distribution of the Neuroguard integrated embolic protection (IEP) system for carotid artery disease following its limited market distribution, the company announced. This follows the announcement earlier this year of an exclusive U.S. distribution agreement between…
FastWave Medical appoints principal investigators for IVL pivotal trial
Venita Chandra, MD, clinical professor of surgery at Stanford Health Care in Stanford, California, will serve as a co-principal investigator for the upcoming investigational device exemption (IDE) pivotal trial of Artero, FastWave Medical‘s peripheral electric intravascular lithotripsy (E-IVL) system. The…
Designated multispecialty CLTI teams may help in amputation fight
Teams formally defined as specializing in chronic limb-threatening ischemia (CLTI) were associated with a decreased risk of major amputation among a subset of BEST-CLI trial sites, a paper recently published online ahead of print in the Journal of Vascular Surgery…
MVSS 2025: Ross Milner ascends to Midwestern Vascular Surgical Society presidency
Ross Milner, MD, the Louis Block professor of surgery and chief of vascular surgery at the University of Chicago, became the new president of the Midwestern Vascular Surgical Society (MVSS) in Cincinnati, Ohio, over the weekend. Milner took over from…
WVS 2025: David Rigberg takes over as president of Western Vascular Society
David Rigberg, MD, clinical professor of surgery, at the UCLA Gonda School of Medicine in Los Angeles, has taken over as president of the Western Vascular Society (WVS). Rigberg became the 2025–26 WVS president at the society’s annual meeting in…
Terumo Aortic announces ‘significant policy milestone’ with CMS establishing new DRG 209 for complex aortic arch procedures
Terumo Aortic today announced what it describes as a “significant policy milestone” with the Centers for Medicare & Medicaid Services (CMS) establishing a new Medicare Severity Diagnosis-Related Group (MS-DRG), MS-DRG 209, for complex aortic arch procedures. A company press release…
Appeal filed over ‘not-approvable’ letter for breakthrough venous valve replacement
Venous valve developer enVVeno Medical has announced that it will file a request for supervisory appeal of the “not-approvable” letter from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) received on Aug. 19,…