July’s top 10 highlights the US Food and Drug Administration’s long-awaited update on paclitaxel-coated devices to treat peripheral arterial disease, an interview with Rachel Bell (Newcastle, UK), and some key industry updates.
1. FDA removes red flag for paclitaxel-coated devices after review finds data do not support mortality risk
In a letter to healthcare providers dated 11 July 2023, the US Food and Drug Administration (FDA) communicates that the risk of mortality associated with paclitaxel-coated devices to treat peripheral arterial disease (PAD) is no longer supported based on the totality of the available data and analyses.
2. SVS responds to New York Times article on overuse of vascular interventions
In an official Society response, SVS president Joseph Mills tackles recent coverage in the mainstream media of inappropriateness in vascular care.
3. Interview: Rachel Bell
A specialist in complex open aortic surgery, Rachel Bell speaks to Vascular News about her career so far. She advocates for retaining open surgery skills in an increasingly endovascular world and underlines some of the key challenges facing the specialty in the wake of COVID-19 and against the backdrop of a health service under “massive stress”.
4. Boston Scientific announces position on FDA update about use of paclitaxel-coated devices to treat PAD
Following the news that the US Food and Drug Administration (FDA) has changed its stance on the use of paclitaxel-coated devices to treat peripheral arterial disease (PAD), Boston Scientific announced its position on the update.
5. Nectero Medical receives FDA clearance of IND application to initiate Phase II/III clinical trial of Nectero EAST system
Nectero Medical recently announced that the US Food and Drug Administration (FDA) has granted investigational new drug (IND) clearance for the company to initiate a prospective, multicentre, randomised clinical trial (the stAAAble study) to evaluate the safety and efficacy of the Nectero endovascular aneurysm stabilisation treatment (EAST) system in patients with infrarenal abdominal aortic aneurysms (AAAs), maximum diameter 3.5–5cm.
6. Novel peripherally-inserted catheter found superior to conventional options
Medical device company Access Vascular has announced the publication of a peer-reviewed study of its HydroPICC peripherally inserted central catheter (PICC) in the Journal of Materials Science: Materials in Medicine. The retrospective study found that HydroPICC “significantly reduced” clot formation and failures, compared with conventional polyurethane PICCs, a press release states.
7. Timeline: Key milestones in the paclitaxel story
The release of a letter from the US Food and Drug Administration (FDA) concerning the use of paclitaxel-coated devices for the peripheral arterial disease (PAD) marks an important chapter in a long-running story.
8. RapidAI announces US$75 million growth investment led by Vista Credit Partners
RapidAI has announced US$75 million in Series C funding led by Vista Credit Partners, a subsidiary of Vista Equity Partners and strategic financing partner focused on the enterprise software, data and technology markets.
9. New study reports positive performance of AI-powered assessment of biomarkers for growth prediction of AAAs
The characterisation of aortic tissue by means of three key biomechanics-based biomarkers bundled into a compound Regional Areas of Weakness (RAW) Map showed “very good performance” as part of an artificial intelligence (AI)-based prediction of faster than average growth for a population of abdominal aortic aneurysm (AAA) patients under serial monitoring, according to a new study published in the Journal of Vascular Surgery-Vascular Science (JVS-VS).
10. Endologix announces first patients treated with the Detour system
Endologix has shared in a press release that the first patients underwent percutaneous transmural arterial bypass (PTAB) using the Detour system since US Food and Drug Administration (FDA) approval of the system was granted. This marks the official start of its US targeted market release.
