Laminate Medical Technologies said today it launched a pivotal, FDA-cleared trial of its VasQ implanted blood vessel device designed for patients requiring arteriovenous fistulas as vascular access for hemodialysis. The Israel-based company’s VasQ device is designed to aid kidney failure patients in need of dialysis by providing external support to reduce fistula failure. The device regulates […]
Vascular
Bluegrass Vascular launches pivotal study for Surfacer vascular access catheter
Bluegrass Vascular Technologies said it enrolled the first patients in a pivotal trial of its Surfacer “inside-out” vascular access catheter. The Surfacer device is designed to provide access to the jugular vein to restore central venous access in hemodialysis patients with blocked neck veins; it won CE Mark approval in the European Union in August 2016; Bluegrass later […]
J&J’s Biosense Webster launches WaveCrest study
Johnson & Johnson‘s (NYSE:JNJ) Biosense Webster said today that the first patient has been enrolled in an investigational device exemption trial for its WaveCrest system. The 1,250-patient study is designed to assess the safety and efficacy of the WaveCrest left atrial appendage occlusion system as a way to reduce the risk of embolic stroke in atrial fibrillation […]
Secant Group officials think they’ve cracked vascular regeneration: Here’s how
Secant Group today announced what it described as game-changing technology to advance vascular regeneration, solving problems that surgeons presently have when it comes to vascular harvesting and the non-resorbable synthetic graft compliance mismatching. The technology, which Secant (Telford, Pa.) developed in partnership with its sister company SanaVita Medical, involves a synthetic, small bore, vessel with a […]
Abbott launches new ablation catheter in Europe
Abbott‘s (NYSE:ABT) sensor-enabled Advisor HD Grid mapping catheter has won CE Mark approval in the European Union. The device is designed for use in any chamber of the heart during cardiac ablation. Physicians use mapping catheters to identify areas of cardiac tissue that are responsible for sending erratic electrical signals that cause arrhythmias. Abbott touted […]
Guerbet to pay $23.7m for Accurate Medical Therapeutics
Contrast agent-maker Guerbet (EPA:GBT) has inked a €19.5 million ($23.7m USD) deal to acquire Israeli medtech company Accurate Medical Therapeutics. Accurate has developed two series of microcatheters designed for embolization procedures of tumors and vascular aneurysms. The first set of catheters optimize the product’s ability to access hard-to-reach lesions and navigate tortuous vascular networks. The second […]
Svelte Medical launches pivotal trial for drug-eluting stent-on-a-wire
The first patient has been enrolled in Svelte Medical System‘s Optimize pivotal trial, which is designed to evaluate the safety and efficacy of Svelte’s drug-eluting stent integrated delivery system and rapid exchange platforms. The 2,000-person trial comes in the wake of a first-in-man trial for Svelte’s product and a study comparing the system with Medtronic‘s (NYSE:MDT) Resolute […]
Gore launches FDA IDE Excluder conformable AAA endoprosthesis trial
W.L. Gore & Associates today announced the first implant of its Gore Excluder conformable abdominal aortic aneurysm endoprosthesis in the US as part of an FDA-approved investigational clinical study. The procedure was performed on December 19 at New York’s Maimonides Medical Center by national principal investigator Dr. Robert Rhee. “Patients with extreme proximal neck anatomies often […]
Infusion catheter developer Ablative Solutions raises $4m
Delaware-based Ablative Solutions has raised $4 million as part of a $10 million round, according to regulatory filings. The company is developing the Peregrine System, an infusion catheter that delivers diagnostic and therapeutic agents to the perivascular space surrounding blood vessels. The 510(k)-cleared device includes three microneedles that remain within radiopaque guide tubes prior to drug delivery. After […]
Corindus joins with Mayo Clinic in study of tele-robotic stenting
Corindus Vascular Robotics (OTC:CVRS) said today it is working with the Mayo Clinic to launch preclinical studies exploring the use of telestenting, a robotic treatment for percutaneous coronary interventions which can be operated by physicians in remote locations. The Waltham, Mass.-based surgical robotics company said that there is a global shortage of PCI-capable operators, and that telestenting […]
Stealthy endovascular dev Provisio Medical raises $4m
Stealthy endovascular device developer Provisio Medical has raised $4 million in a new round of Series B preferred stock, according to an SEC filing posted this week. Provisio has not released any information on its developments outside its focus on endovascular therapy, which it displays on its website. The company is headed by former Volcano […]