Interventional News’ most popular content last month featured a report on the need for greater interventional radiology (IR) service coverage in rural areas of the USA; news of a US Food and Drug Administration (FDA) premarket approval (PMA) submission by Endologix; new restorative haemodialysis access graft data from Xeltis; and the release of three-year effectiveness data for the Abre stent (Medtronic).
1) Cordis announces acquisition of MedAlliance
Cordis announced its acquisition, subject to customary closing conditions including regulatory approvals, of MedAlliance.
2) Report highlights need for recruitment and retention of IRs in rural practices
A new report from a joint taskforce of the American College of Radiology (ACR) and the Society of Interventional Radiology (SIR) recommends improved access to interventional radiologists in small and rural areas.
3) Endologix submits premarket approval application to FDA for the Detour system
Endologix has announced the submission of a PMA application requesting approval for the Detour system to the US FDA.
4) Xeltis presents “promising” first-in-human data on restorative haemodialysis access graft
Xeltis today announced what it describes as “very promising” preliminary efficacy and safety results from one of the centres participating in the AXESS study—a first-in-human (FIH) clinical trial of its restorative haemodialysis access graft, Axess.
Cardiovascular Systems Inc (CSI) has announced the full market release of the 2.00 Max Crown for peripheral orbital atherectomy systems (2.00 Max Crown).
6) Interventional radiology outpatient clinic: Another success story
Roberto Luigi Cazzato speaks to Interventional News about the emergence of IR outpatient clinics (IROCs) and his view that IR hospitalisation clinics (IRHCs) will soon begin being established too.
7) XACT Robotics receives FDA clearance for remote control unit
XACT Robotics announced that its ACE Xtend remote control unit received US FDA clearance, allowing users to robotically insert and steer the XACT ACE Robotic System remotely from the control room.
8) Preliminary MOTIV BTK outcomes positive for bioresorbable scaffold use in below-the-knee lesions
Thomas Rand (Klinik Florisdorf, Vienna, Austria) presented on the preliminary results to 12 months of the Motiv bioresorbable scaffold (Reva Medical) postmarket trial at the recent Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2022 annual meeting (10–14 September, Barcelona, Spain).
9) Three-year data show sustained effectiveness of Abre stent
Medtronic has announced the 36-month final results from the ABRE clinical study, the puropse of which was to evaluate the safety and effectiveness of the Abre venous self-expanding stent system, intended for the treatment of symptomatic iliofemoral venous outflow obstruction.
In the USA, atherectomy use in peripheral vascular interventions (PVIs) “more than doubled” from 2010 to 2019, with office-based procedures a “major driver” of this increase. This is according to published US data from the Vascular Quality Initiative (VQI).
