Discussions on the role of aritifical intelligence in the vascular field and emerging deep venous valve technologies caught readers’ attention in September.
Humacyte has announced positive top line results from its V005 Phase 2/3 trial of the Human Acellular Vessel (HAV) in vascular trauma repair.
2. Shape Memory Medical receives US FDA IDE approval to initiate head-to-head AAA-SHAPE trial
Shape Memory Medical recently announced that the US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) for the company to begin a prospective, multicentre, randomised, open-label trial to determine safety and effectiveness of the Impede-FX RapidFill device to improve abdominal aortic aneurysm (AAA) sac behavior when used with elective endovascular aneurysm repair (EVAR).
3. “A hugely exciting time”: Experts focus in on artificial intelligence in the vascular field
Can we trust artificial intelligence (AI)? Will AI replace physician judgement? Experts recently addressed these and other key questions amidst an expansion of AI technologies in the vascular space.
4. US FDA approves LimFlow system for treatment of CLTI
The US Food and Drug Administration (FDA) has announced approval of LimFlow therapy—a novel and minimally invasive procedure designed to bypass blockages in arteries of the legs and restore blood flow for many thousands of people suffering from chronic limb-threatening ischemia (CLTI).
5. Patient voice central to new trial addressing nerve catheter PLACEMENT in major amputation care
David Bosanquet (South East Wales Vascular Network, Cardiff, UK) is chief investigator of a new randomised trial—PLACEMENT—which addresses the topic of pain control around the time of a major amputation. Here, he speaks to Vascular News about the importance of such a trial, the challenges associated with conducting a randomised study, and the central involvement of the patient voice in this new research.
6. Biotronik announces two-year results from BIOLUX P-III BENELUX all-comers registry
Biotronik recently announced two-year-results from the BIOLUX P-III BENELUX all-comers registry, presented by principal investigator Frank Vermassen (UZ Ghent, Ghent, Belgium) at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual congress 2023 (9–13 September, Copenhagen, Denmark). The prospective, international, multicentre postmarket registry evaluated the safety and efficacy of the Passeo-18 Lux drug-coated balloon (DCB) catheter in isolated popliteal artery lesions.
7. Deep venous valve technologies set to address “large unmet need worldwide”
The pursuit of a cure for deep venous valvular reflux—long considered to be the “holy grail” of deep venous disease—is underway, with new technologies set to address a longstanding unmet clinical need across the globe.
“With effective use of apron and ceiling and table shields, operator [radiation] doses can be reduced to the equivalent of one to two days of natural background radiation,” investigators write in the conclusion of a recently published study.
9. FastWave Medical secures multi-million dollar private financing within weeks
FastWave Medical recently announced the swift closure of an oversubscribed multi-million dollar private financing. A press release states that this achievement, secured in just a few weeks, highlights the growing interest and confidence in FastWave’s ability to execute its vision for the development of multiple intravascular lithotripsy (IVL) systems.
10. Society for Vascular Surgery launches national smoking cessation initiative
The Society for Vascular Surgery’s Patient Safety Organization (SVS PSO) has launched a national smoking cessation initiative. It includes tools and resources to help physicians, surgeons and other healthcare professionals to help their patients kick the smoking habit.
