FDA Breakthrough Device designation granted for DynamX BTK for use in CLTI treatment below the knee

Elixir Medical has announced Breakthrough Device designation by the Food and Drug Administration (FDA) for its novel DynamX BTK System, an implant for use in the treatment of narrowed or blocked vessels below-the-knee (BTK) in patients with chronic limb-threatening ischemia…
Bentley, Cook Medical enter US distribution agreement for BeBack device

Cook Medical and Bentley today announced a distribution agreement for the BeBack crossing catheter in the U.S., with Cook assuming commercial responsibilities for the Bentley product in the coming months. The BeBack device is designed for steering through chronic total…
Multi-society PAD Pulse Alliance aims to highlight importance of patient education

Society for Vascular Surgery (SVS) experts are spearheading initiatives as part of the multispecialty PAD Pulse Alliance and its Get a Pulse on PAD public awareness campaign aimed at educating and raising awareness of the risk factors and potential symptoms…
New analysis points to lack of vascular surgical voices in news coverage of vascular disease

A new study set to be aired at the 2024 Society for Clinical Vascular Surgery (SCVS) annual meeting (March 16–20) in Scottsdale, Arizona, sheds a statistical spotlight on the state of the specialty’s reach into the mainstream consciousness. A team…
IVUS use in claudicants not associated with improved outcomes, claims data show

The use of intravascular ultrasound (IVUS) for the treatment of claudication doubled over a four-year period but there was “no clear relationship between IVUS use and improved patient outcomes,” a recently presented retrospective analysis of claims data showed. Researchers found…
The top 10 most popular Vascular Specialist stories of February 2024

In February, the most read stories from Vascular Specialist include a study of metformin and its potential as the first-ever medical treatment that can manage aneurysm disease; the SVS Sub-Section on Outpatient and Office Vascular Care (SOOVC) release the highly anticipated…
Endologix initiates postmarket study of the Detour system

Endologix has announced the initiation of the Percutaneous transmural arterial bypass (PTAB)1 postmarket study. This study marks the beginning of a comprehensive postmarket study aimed at evaluating the real-world performance of the Detour system in patients undergoing treatment for long…
Trial assessing AI-powered tissue microsensor technology in PAD begins enrollment

Sensome has announced enrollment of the first patients into a feasibility clinical study using the Clotild smart guidewire in peripheral arterial disease (PAD). Clotild was designated a breakthrough medical device for use in brain arteries by the Food and Drug Administration (FDA)…
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).…
The top 10 most popular Vascular Specialist stories of January 2024

In January, the most read stories from Vascular Specialist include a U.S. Aortic Research Consortium analysis of F/BEVAR preoperative risk factors in AAAs/TAAAs; a reflection on lessons learnt one year on from BEST-CLI; Southern Vascular’s election of its first female…

