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Endologix announces 36-month results of DETOUR2 study
Endologix has announced the final 36-month results from the DETOUR2 study—a prospective, single-arm, international, multicentre clinical evaluation of the novel Detour system for fully percutaneous femoropopliteal bypass procedures. A press release details that the findings highlight the durable efficacy of…
New analysis shows patients treated with Penumbra’s CAVT technology for PE utilize fewer hospital resources
Penumbra has announced new data that demonstrate patients with intermediate-risk pulmonary embolism (PE) treated with Penumbra’s computer-assisted vacuum thrombectomy (CAVT) technology have a shorter length of hospital stay, shorter post-procedure length of stay and fewer complications when compared to other…
Shockwave Javelin peripheral IVL catheter meets prespecified efficacy and safety performance goals in feasibility and IDE studies
Shockwave Medical, part of Johnson & Johnson MedTech, has announced the first clinical outcomes associated with the Shockwave Javelin peripheral intravascular lithotripsy (IVL) catheter, a novel, non-balloon-based lithotripsy platform designed to modify calcium and cross extremely narrowed vessels in patients…
Bolt Medical announces completion of RESTORE ATK and RESTORE BTK pivotal studies investigating Bolt IVL system
Bolt Medical has announced the completion and results of the RESTORE ATK and RESTORE BTK pivotal clinical trials investigating the company’s Bolt intravascular lithotripsy (IVL) above-the-knee (ATK) and below-the-knee (BTK) systems for the treatment of peripheral arterial disease (PAD) in…
Two-year LIFE-BTK data show sustained benefits of drug-eluting resorbable scaffold for below-the-knee arteries
Presented today, late-breaking data from the second year of the LIFE-BTK clinical trial demonstrate the long-term effectiveness of the US Food and Drug Administration (FDA)-approved Esprit BTK everolimus-eluting resorbable scaffold system (Abbott Vascular) in patients with the most severe form…
First patient enrolled in study of integrated laser atherectomy and IVL catheter
Royal Philips has announced enrolment of the first patient in the US THOR IDE clinical trial, which will study an innovative combined laser atherectomy and intravascular lithotripsy (IVL) catheter. Procedures that previously required the use of two different devices can…
FDA grants R3 Vascular IDE approval for ELITE-BTK pivotal trial of Magnitude drug-eluting bioresorbable scaffold
R3 Vascular today announced that the Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval to initiate its ELITE-BTK pivotal trial of the next-generation Magnitude drug-eluting bioresorbable scaffold for below-the-knee (BTK) peripheral arterial disease (PAD). “We are…
TCT 2024: Drug-eluting resorbable scaffold proves cost effective at one year in LIFE-BTK analysis
A retrospective economic analysis of the LIFE-BTK trial has demonstrated the one-year cost-effectiveness of an everolimus-eluting resorbable scaffold over angioplasty for the treatment of infrapopliteal artery disease, with investigators predicting more significant results in the longer term. Sharing this finding…
CMS grants transitional pass-through payment for Medtronic’s Symplicity Spyral and Recor’s Paradise renal denervation systems
The Centers for Medicare and Medicaid Services (CMS) has granted transitional pass-through (TPT) payment for Medtronic’s Symplicity Spyral renal denervation (RDN) catheter and Recor Medical’s Paradise ultrasound RDN (uRDN) system, according to press releases from the two companies. TPT payment,…
Endoscopic vein harvest under the microscope
Conflicting results open fresh debate around effect of vein harvesting technique on long-term patency of lower extremity bypass grafts. Two separate analyses that looked at the impact made by the method used to harvest great saphenous vein (GSV) on the…