Several company updates including Series A funding for Endoron Medical, new insights on the role of machine learning in determining endovascular aneurysm repair (EVAR) suitability, and more from this year’s Vascular Annual Meeting (VAM 2024; 19–22 June, Chicago, USA) all feature in July’s top 10.
1. 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 descending thoracic aorta while maintaining flow into the left subclavian artery (LSA) in patients with appropriate anatomy.
2. Humacyte’s ATEV granted US 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 designation was granted at the same time as the FDA cleared a new Investigational New Drug (IND) application for the PAD indication for ATEV, formerly referred to as the human acellular vessel (HAV).
3. CEA and TCAR should be “first-line” interventions for weekend carotid revascularisation, researchers advise
Patients who undergo carotid revascularisation at the weekend have increased odds of complications and mortality, with transfemoral carotid artery stenting (TFCAS) posing the highest risk and transcarotid artery revascularisation (TCAR) the lowest, compared to carotid endarterectomy (CEA). This is one of the key findings of new observational research published online ahead of print in the Journal of Vascular Surgery (JVS).
4. Machine learning-based model could aid in determining EVAR suitability
Researchers at the University Medical Center Groningen (Groningen, The Netherlands) and the University of Twente (Enschede, The Netherlands) have developed a prediction model that they claim could assist in the preoperative identification of patients who are unlikely to achieve sufficient endograft apposition after endovascular aneurysm repair (EVAR).
5. Life Seal Vascular awarded NSF SBIR grant to advance sac management technology for EVAR
Life Seal Vascular recently announced that it has been awarded a National Science Foundation (NSF) Small Business Innovation Research (SBIR) grant. The funding will be used to accelerate the development of the company’s endovascular aneurysm repair (EVAR) technology.
6. Endoron Medical raises US$10 million in Series A funding
Endoron Medical has reported the successful closing of its US$10 million Series A funding round. The round was led by Sofinnova Partners, with significant matching contributions from the European Innovation Council Fund (EIC Fund).
7. Artivion amends agreements with Endospan
Artivion recently announced it has amended its credit facility and option purchase agreements with Endospan, developer of the Nexus stent graft system. In 2019, Artivion provided a credit facility to Endospan and entered into an option agreement to purchase Endospan upon US Food and Drug Administration (FDA) approval of Nexus.
8. First patients treated in US GPS study of Paradise renal denervation system
The first patients in the USA have been treated in Recor Medical’s Global Paradise System US Post Approval Study (US GPS), a real-world study gathering data on the long-term safety and effectiveness of ultrasound renal denervation.
9. Smoking cessation remains a “ripe target” for improved medication adherence in carotid disease
New data presented at the 2024 Vascular Annual Meeting (VAM; 19–22 June, Chicago, USA) have revealed poor overall rates of medical therapy adherence in moderate asymptomatic carotid stenosis patients—with smoking cessation representing a “ripe target” for improvement moving forward.
10. First results of SOL Japan highlight “extraordinary performance” of Luminor DCB in Japanese population
iVascular has shared that “outstanding” results from the SOL Japan study were recently presented at the Japan Endovascular Treatment (JET) conference (14–16 June, Fukuoka, Japan).
