Dr. Dean Kereiakes knows a thing or 2 about coronary stents – he’s been a principal investigator in a number of clinical trials evaluating coronary stents over the past 20 years. So it counts when Kereiakes names the Synergy stent made by Boston Scientific‘s (NYSE:BSX) “the safest stent yet.” An interventional cardiologist at the Christ Hospital, he was also a […]
Vascular
Creo Medical wins expanded CE mark for Speedboat RS2 electrosurgical device
Creo Medical said today it won expanded CE mark approval for its Speedboat RS2 electrosurgical device, now cleared for the use of microwave energy as well as radiofrequency. The U.K.-based company said that in a 30-patient clinical study, the Speedboat RS2 successfully demonstrated safety and efficacy in applying microwave energy to coagulate bleeds in the colon. […]
Intact Vascular finishes patient enrollment for angioplasty clinical trial
Intact Vascular said today that it finished enrollment for the Toba II clinical trial evaluating its Tack Endovascular System in combination with standard or drug coated balloon angioplasty in arteries above the knee. The company’s trial enrolled 210 patients and will focus on the superficial femoral artery and the proximal segment of the popliteal artery, […]
Tryton Medical touts 1st commercial implant of Side Branch stent
Tryton Medical said today that its Side Branch Stent designed to treat coronary bifurcation lesions has been used in its 1st commercial procedure, performed by Dr. Martin Leon and Dr. Ajay Kirtane at the New York-Presbyterian Hospital . The side-branch stent is designed to be compatible with any conventional drug-eluting stent in the main vessel, and comes […]
EndoShape raises $10.5m
EndoShape has raised $10.5 million in a new round of equity financing, according to an SEC filing posted by the company. The Boulder, Colo.-based device maker develops minimally invasive plugs and coils for occluding blood vessels, including its flagship Medusa MultiCoil, which has FDA 510(k) clearance. The device is indicated for arterial and venous embolization […]
Humacyte wins expedited review designation for acellular vessel
Humacyte said today that the FDA granted its investigational human acellular vessel, Humacyl, the regenerative medicine advanced therapy designation. The regulatory win means that the FDA will expedite its review of the HAV for patients in need of life sustaining hemodialysis. The designation is new and follows the model of other FDA programs such as the […]
Biotronik touts Orsiro data at Japanese conference
Biotronik touted data today from the BioFlow-IV study of its Orsiro hybrid drug-eluting stent at this year’s Japan Circulation Society congress. The company’s study enrolled 579 patients with de novo coronary lesions and randomized them to receive either the Orsiro stent or Xience stent. After 12 months, the researchers confirmed non-inferiority of its stent, based […]
Cardiva Medical closes $30m equity round
Vascular closure device dev Cardiva Medical said yesterday it closed a $30 million round of equity financing to support the commercial expansion of its Vascade vascular closure system. The round was joined by affiliates of Luther King Capital Management with participation from existing major investors, including PTV Healthcare Capital and Canepa Advanced Healthcare Fund, the […]
AngioDynamics wins CE Mark for Solero microwave tissue ablation system
AngioDynamics (NSDQ:ANGO) said today it won CE Mark approval in the European Union for its Solero microwave tissue ablation system, with indications for ablation of soft tissue during open, laparoscopic or percutaneous procedures. The Albany, N.Y.-based company’s Solero MTA system features a 2.45GHz microwave generator with an operating frequency up to 140 watts and a ceramic […]
PQ Bypass wins CE Mark for trio of PAD tools
PQ Bypass said today it won CE Mark approval for 3 devices designed to treat patients with superficial femoral artery lesions due to peripheral artery disease. The Sunnyvale, Calif.-based company said it won clearance for its Torus stent graft system, PQ Snare and PQ crossing device, all used in the company’s Detour procedure. “With an increased focus […]
BTG’s Ekos device targets pulmonary embolism with drug, ultrasound wave combo therapy
Each year, pulmonary embolisms kill more people in the U.S. than AIDs and breast cancer combined, according to BTG (LON:BTG). Venous clots in the legs or arm break off and travel through a patient’s circulatory system, eventually getting trapped in the lung and blocking the flow of blood. In some cases, this strains the heart’s ability to […]