In June, the most popular stories from Interventional News included new data from the C-GUARDIANS pivotal investigational device exemption (IDE) trial; positive 12-month results from the Selution SFA Japan trial; and a range of industry updates.
Boston Scientific has announced that it has entered into a definitive agreement to acquire Silk Road Medical, a medical device company involved in producing products to be deployed during transcarotid artery revascularisation (TCAR). The purchase price is US$27.50 per share, reflecting an enterprise value of approximately US$1.16 billion.
2. The hidden interventional radiologists: Study uncovers those lost in data
A study conducted by the Harvey L Neiman Health Policy Institute (HPI) has identified a large percentage of unidentified interventional radiologists ‘hidden’ within Medicare data. The research has uncovered a previously unforeseen trapdoor, in which self-designated specialty in Medicare claims data have proven to be an “inadequate selection method” resulting in the omittance of practicing interventional radiologists from records.
3. Cook Medical announces Beacon sizing tip catheter availability in USA and Canada
Cook Medical have announced that Beacon tip sizing catheters are now available in the USA and Canada. The Beacon catheter is available in a variety of lengths and tip configurations, a recent press release adds.
4. Xeltis receives IDE approval from US FDA for haemodialysis vascular access conduit
Xeltis has announced that it has gained approval from the US Food and Drug Administration (FDA) for an investigational device exemption (IDE) submission to begin enrolling patients into a pivotal study for aXess.
5. LINC 2024: C-GUARDIANS data represent lowest event rates in published trials of CAS, TCAR and CEA
New data from the C-GUARDIANS pivotal investigational device exemption (IDE) trial support consideration of carotid artery stenting (CAS) with the CGuard embolic prevention stent system (EPS; InspireMD) as a “frontline therapeutic option for appropriate patients being considered for carotid revascularisation”. This is according to lead investigator Chris Metzger (OhioHealth, Columbus, USA), who presented one-year results from the trial at the Leipzig Interventional Course (LINC) 2024 (28–31 May, Leipzig, Germany).
6. Medical Templates announces FDA clearance for CT guidance software
Medical Templates has announced that they have received US Food and Drug Administration (FDA) clearance for their Cube Navigator software for planning of percutaneous, computed tomography (CT)-guided interventions.
7. Cordis announce positive 24-month results from Selution SFA Japan trial
Cordis has announced positive 24-month results from the Selution SFA Japan trial. The prospective, multicentre, single arm trial is designed to assess the safety and efficacy of Selution SLR drug-eluting balloon (DEB) for the endovascular therapy of de novo and non-stented restenotic lesions in the superficial femoral artery (SFA) and the popliteal artery (PA). The findings were presented at the Japan Endovascular Treatment (JET) conference (14–16 June, Fukuoka, Japan).
8. Penumbra announces European launch of neuro access catheters
Penumbra has announced that it has received CE mark approval and so has initiated the European launch of BMX81 and BMX96, devices which are designed for neurovascular management of ischaemic and haemorrhagic stroke.
9. AVS receives IDE approval from US FDA for pivotal intravascular lithotripsy study
Amplitude Vascular Systems (AVS) announced today that it has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to begin its pivotal trial for pulsatile intravascular lithotripsy (IVL) therapy.
10. Johnson & Johnson completes acquisition of Shockwave Medical
Johnson & Johnson today announced it has completed its acquisition of Shockwave Medical. Shockwave is now part of Johnson & Johnson and will operate as a business unit within Johnson & Johnson MedTech.
