Cardiovascular device specialist ReFlow Medical Inc. has gained CE mark approval for its Wingman35 Crossing Catheter and speX™ Shapeable Support Catheter.
Vascular
New Trials Underscore Covidien’s Neurovascular Intentions
Covidien has announced the start of enrollment in two clinical trials that it says further underscores the safety and effectiveness of the company’s advanced neurovascular solutions.
Cook Medical Recalls CloverSnare™ 4-Loop Vascular Retrieval Snare
Cook Medical has initiated a recall of 696 of its CloverSnare™ 4-Loop Vascular Retrieval Snare devices because of a potential for device failure with serious consequences.
First Patient in Cook’s Zilver PTX Drug Stent Chinese Study
Cook’s peripheral drug stent, the first of its kind in China, is being conducted at up to 20 clinical sites and will enroll 175 patients with one-year follow-up.
FDA Clears 150 cm Arrow® GPSCath® Balloon Dilatation Catheters
Teleflex subsidiary Hotspur Technologies has gained FDA clearance for its 150cm length Arrow GPSCath dual function balloon dilatation catheters.
UK’s NICE Info on Vein Visualisation System Falls Short of Being Guidance
The UK’s Healthcare watchdog has issued a Medtech Innovation Briefing on the AccuVein AV400 for vein visualisation
Now FDA Clear CorMatrix® ECM® for Vascular Repair
CorMatrix Cardiovascular has extended the application of its CorMatrix® ECM® having received U.S. FDA clearance to market the material for Vascular Repair.
CE Mark for Boston Scientific’s Ranger™ Drug-Coated Balloon
Boston Scientific Corporation has received CE Mark for the Ranger™ Paclitaxel-Coated PTA Balloon Catheter which is now to be fully launched in Europe.
New IDE Study: Will Vici Stent Conquer Venous Stent Market?
The U.S. FDA has given the go ahead to Veniti’s Vici Venous Stent system which the company says is the first to be designed specifically for venous use.
Covidien Launches Enhanced Trellis Clot-Busting System
Covidien’s Trellis Peripheral infusion system features enhanced drug delivery and better clot removal.
Race is on as FDA Panel Vote Leaves C.R.Bard on Verge of First Drug Coated Balloon Approval
Lutonix® DCB is one step closer to becoming the first FDA-approved drug coated balloon for the treatment of patients with femoropopliteal occlusive disease following the FDA Circulatory devices panel vote.
Medtronic’s Drug Coated Balloon Aims to be U.S. First for Peripheral Artery Disease
Medtronic has submitted the final module of its PMA application. A successful outcome would make the IN.PACT Admiral drug-coated balloon the first of its kind approved for Peripheral Artery Disease.
FDA IDE for PulseRider® Intracranial Bifurcation Aneurysm Device
Pulsar Vascular receives FDA IDE approval for the PulseRider® Aneurysm Neck reconstruction device for the treatment of intracranial bifurcation aneurysms
BioMimics 3D Stent Results May Signal New Performance Benchmark in Fem-Pop Stenting
Results showing that use of the BioMimics 3D ™ vascular stent offer improved maintenance of patency over two years compared with traditional straight stent, have been presented at last week’s NCVH conference.
U.S. FDA Clears EkoSonic® Endovascular System for Treatment of Pulmonary Embolism
EKOS Corporation has gained U.S. FDA clearance to market its EkoSonic® Endovascular System for the ultrasound-facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism (PE).
St. Jude Pretends Symplicity HTN-3 Didn’t Happen as it Reports Positive EnligHTN III Results
Preliminary results from the St. Jude Medical EnligHTN III study suggest the company’s second-generation EnligHTN™ renal denervation system provides safe and effective therapy for patients with drug-resistant, uncontrolled hypertension six months post-procedure.