Mercator MedSystems said last week that it raised $14.3 million from 25 investors as part of a $15 million equity round. The California-based company is developing catheter-guided micro-infusion systems for non-systemic delivery of therapeutic agents across blood vessels as a treatment for peripheral artery disease. Get the full story at our sister site, Drug Delivery Business […]
Vascular
Silk Road Medical touts results of carotid artery treatment study
A new study shows that transcarotid artery revascularization (TCAR) procedures significantly lowered the odds of composite in-hospital stroke, death and heart attack compared to surgical removal of plaque from the carotid artery, according to Silk Road Medical (NSDQ:SILK). The company is developing a neuroprotection and stent system called Enroute as an aid to TCAR procedures. […]
Bluegrass Vascular’s pivotal Surfacer trial meets primary endpoints
Bluegrass Vascular Technologies today released preliminary results from the pivotal trial of its Surface Inside-Out access catheter system, touting that the trial met both its primary and secondary endpoints. The San Antonio-based company also said that it has completed enrollment in the SAVE-US trial, recruiting 30 patients across seven U.S.-based centers. “I’m quite encouraged by […]
U.K. says doctors should limit use of paclitaxel devices
U.K. medtech regulators have recommended a ban on routine use of paclitaxel drug-coated balloons (DCBs) and drug-eluting stents in patients with intermittent leg cramps, but held back on recommending the same for patients with critical limb ischemia. U.S., U.K. and French regulators began raising concerns about the risk of increased long-term mortality in people with […]
Terumo recalls select Solopath balloon systems
Terumo (OTC:TRUMY;TYO:4543) is recalling a select number of its Solopath balloon expandable transferal system and re-collapsible balloon access systems due to issues with tip dislodgment from the sheath that could cause possible patient injuries. The FDA has labeled the recall as Class I, its most severe classification which is used when there is a reasonable probability […]
Argon Medical Devices buys its U.K. distributor
Argon Medical Devices (Frisco, Texas), an OEM manufacturer of specialty medical products, custom components and drainage catheters, announced that it has completed the acquisition of Mana-Tech, Ltd., its exclusive distributor for the United Kingdom and Ireland. Mana-Tech (Burton-on-Trent, England) is a distributor of biopsy products and radiology consumables in the U.K. The entire Mana-Tech team, including its […]
Novuson Surgical wins backing from Hoya
Ultrasound-tech developer Novuson said on Tuesday that it is receiving funding from Japan’s Hoya Corp. (TYO:7741) to support the finalized development of its direct therapeutic ultrasound (DTU) UltraStat 3mm vessel sealer and divider. The Bothell, Wash.-based company said that the DTU system is a novel approach using a therapeutic modality of ultrasound that avoids the need for […]
Philips touts Stellarex drug-coated balloon data
Patients using Royal Philips’s (NYSE:PHG) Stellarex drug-coated balloon maintained blood flow through the treated segment of diseased arteries at three years in a pair of clinical trials. Stellarex is designed to restore and maintain blood flow in the superficial femoral artery and peripheral arteries. It’s coated using the company’s EnduraCoat technology to elute the drug paclitaxel. Spectranetics won […]
Shape Memory Medical’s embolization plug wins FDA clearance
Shape Memory Medical said today it has received FDA 510(k) clearance for its Impede-FX embolization plug designed to obstruct or reduce the rate of blood flow in the peripheral vasculature. The Impede-FX plug is an adjunct to the Santa Clara, Calif.-based company’s Impede embolization plug, which received 510(k) clearance in 2018. The newly cleared plug […]
Intact Vascular raises $25m for Tack vascular closure device
Intact Vascular said today that it raised a $25 million funding round for the Tack vascular closure device it won an FDA nod for last month. The round was led by Vensana Capital, joined by existing backers New Enterprise Assoc., H.I.G. BioHealth Partners and Quaker Partners, the Wayne, Pa.-based company said. The first tranche of […]
EuroPCR 2019: Paclitaxel meta-analysis a ‘typhoon in a teapot’
The meta-analysis that suggested there was a link between paclitaxel-coated devices and heightened mortality compared to bare devices was described as a “typhoon in a teapot” at this year’s EuroPCR meeting, according to a report from MedScape. Dr. Alexandra Lansky of Yale University School of Medicine, who authored the organization’s formal statement on the matter, reportedly questioned the […]