Medtronic gains FDA nod for IN.PACT 018 DCB

Medtronic has announced approval from the Food and Drug Administration (FDA) for the IN.PACT 018 paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter, a drug-coated balloon (DCB), indicated for the interventional treatment of peripheral arterial disease (PAD) in the superficial femoral…
CX 2022: IN.PACT AV DCB shows sustained and superior performance compared to PTA through three years

New randomized controlled data demonstrating the sustained and superior performance of IN.PACT AV drug-coated balloons (DCBs) compared to percutaneous transluminal angioplasty (PTA) through 36 months, with no difference in mortality, was revealed during a Podium 1st presentation at the 2022 Charing…
Cydar Medical announces strategic collaboration with Medtronic

Cydar Medical recently announced it has entered a strategic collaboration with Medtronic. Under the pilot arrangement, Cydar’s EV Maps software will be introduced to up to 40 new global sites, combining Cydar’s augmented intelligence technology with Medtronic’s services and case support,…
Medtronic issues voluntary recall for subset of IN.PACT Admiral and IN.PACT AV DCBs

Medtronic recently voluntarily recalled a subset of its IN.PACT Admiral and IN.PACT AV paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheters due to the potential for pouch damage resulting in a loss of sterility. This is according to a news alert…
The top 10 most popular Vascular Specialist stories in January

January’s top 10 includes “Our forever plague,” a combined editorial by Malachi Sheahan III, MD, our medical editor, on fake news and science, and coverage of the U.S. investigational device exemption (IDE) Aortic Research Consortium and how the chief investigators…
Medtronic issues voluntary recall for TurboHawk Plus directional atherectomy system

On Feb. 7, Medtronic issued a notice emphasizing that the same warnings and precautions issued for the HawkOne directional atherectomy system also apply for the company’s TurboHawk Plus 6Fr system due to design similarities. The company stresses that this is…
ISET 2022 audience hears latest data on endovascular therapies

At this year’s International Symposium on Endovascular Therapy (ISET), being held Jan. 16–19 in Hollywood, Florida, experts presented an array of late-breaking trial results on topics ranging from venous stenting to abdominal aortic aneurysm (AAA) sac sealing. Waseem Wahood, MS, a…
IN.PACT Admiral DCB performs well across wide range of clinical, anatomical scenarios in pooled analysis

In a pooled analysis of the predictors of drug-coated balloon (DCB) effectiveness, the IN.PACT Admiral DCB (Medtronic) performed well across a broad range of clinical, anatomical and procedural scenarios. This is according to Prakash Krishnan, MD, an interventional cardiologist at Mount Sinai…
Benefits of percutaneous fistula creation further bolstered by five-year Ellipsys data

The Ellipsys vascular access system (Avenu Medical/Medtronic) can be used to easily and safely create durable percutaneous arteriovenous fistulas (pAVFs) for haemodialysis—with new, long-term data suggesting it offers an “excellent alternative” to AVF creation via surgical procedures in end-stage renal…
VIVA 2021: IN.PACT Admiral DCB found to provide ‘high five-year freedom from clinically driven TLR’ in patients with complex lesions

Real-world data drawn from the IN.PACT Global study looking at five-year freedom from clinically driven target lesion revascularization (TLR) among prespecified chronic total occlusion (CTO), long lesion and de novo in-stent restenosis (ISR) cohorts “continues to confirm long-term clinical safety…

