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BASIL-3 plans to re-open enrolment

The halted BASIL-3 study now plans to resume enrolment of patients into the randomised controlled trial, which is comparing balloon angioplasty versus stenting for...

World vascular societies announce new global guidelines for chronic limb-threatening ischaemia

Four years ago, vascular experts from around the world had a "quixotic quest", to get all surgeons and providers to agree on the best...

FDA recalls SoloPath vascular access system following reports of malfunction

The US Food and Drug Administration have issued a Class I Recall of the SoloPath (Terumo Medical) ballon-expandable transfemoral system and re-collapsible balloon access...

Late-breaking ILLUMENATE data demonstrate three-year safety and efficacy for Stellarex DCB

Three-year results from the ILLUMENATE Pivotal trial and the ILLUMENATE European randomised controlled trial (EU RCT) have been presented in a late-breaking trial session...

New global guideline on critical limb-threatening ischaemia finalised, awaiting publication

The long-awaited Global Vascular Guidelines for chronic limb-threatening ischaemia have been finalised, with the comprehensive guideline set to be published shortly. The news were...

BIOPACT-RCT set to compare Passeo-18 Lux and IN.PACT Admiral DCBs in...

iD3 Medical has announced that it has received approval in Belgium to initiate a randomised controlled trial, BIOPACT-RCT: a physician-initiated multicentre trial evaluating the...

Surmodics Sublime guide sheath receives FDA 510(k) approval

Surmodics has announced it has received US Food and Drug Administration (FDA) 510(k) clearance for its Sublime guide sheath. The highly flexible, proprietary Xtreme braid-reinforced...

Surmodics provides update regarding TRANSCEND clinical trial

Surmodics has announced the company has now resumed patient enrolment into its TRANSCEND clinical trial, and is nearly 75% of the way to its...

Reflow Medical completes enrolment in the Wing-IT IDE CTO clinical trial

Reflow Medical has announced the completion of enrolment in its Wing-IT investigational device exemption (IDE) trial; a prospective, multicentre, nonrandomised study evaluating the ability...

BD announces launch of UltraScore 014 Focused Force PTA Balloon

BD has announced the launch of their UltraScore 014 Focused Force percutaneous transluminal angioplasty (PTA) Balloon. This marks the first scoring balloon with sheath...

UK MHRA forms Expert Advisory Group to review paclitaxel devices while...

The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the Food and Drug Administration (FDA) in the USA have both recently...

Augmented reality surgical technology unveiled by Philips and Microsoft

At the MWC (25–26 February, Barcelona, Spain), formerly the Mobile World Congress, Philips unveiled a unique mixed reality concept developed in partnership with Microsoft for...

Passeo-18 Lux DCB remains safe and effective at two years with...

Two-year data on the Passeo-18 Lux drug-coated balloon (DCB; Biotronik) continue to validate its safety and effectiveness in intra-inguinal arteries. Gunnar Tepe from the...

Alvimedica announces CE mark of Cre8 EVO 2.0mm

Alvimedica has announced the company has received CE mark for the Cre8 EVO 2.0mm, a polymer-free Amphilimus-eluting stent. In a press release, Alvimedica states it...

SIBERIA trial: Positive one-month results for embolic prevention system

InspireMD has announced positive interim results from the SIBERIA trial, an investigator-initiated study of the CGuard embolic prevention system (EPS). The data were presented...

US FDA evaluating paclitaxel data, recommend patient surveillance

The impact of the 2018 meta-analysis of randomised paclitaxel-device trials, published in the Journal of the American Heart Association by Konstantinos Katsanos et al,...

Contego Medical receives 510(k) clearance for Vanguard IEP system

Contego Medical has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for its Vanguard IEP Peripheral Balloon Angioplasty System...

Gore moulding and occlusion balloon for endovascular aortic repair receives approval...

Gore has announced FDA 510(k) clearance, approval from the Japanese Ministry of Health, Labour, and Welfare, and receipt of CE mark for the innovative...

Cook Medical introduces a new length of Zilver PTX

Cook Medical has introduced the 140mm-length Zilver PTX drug-eluting peripheral stent in both 6 and 7mm diameters in the USA. The longer length comes...

Boston Scientific announces agreement to acquire Veniti

Boston Scientific has signed an agreement to acquire Veniti, a privately-held company in Fremont, USA which developed and commercialised the Vici venous stent system for...

Peripheral DCB SeQuent Please OTW approved for reimbursement in France

B. Braun has announced the recent French reimbursement approval for its peripheral drug-coated balloon (DCB) SeQuent Please OTW effective as of July 2018. As published...

NIH awards US$2 million grant to Embolx’ pressure-directed embolization device research

The US National Institute of Health (NIH)'s National Cancer Institute has awarded a US$2 million grant to medical device company Embolx. The Small Business...