MedAlliance this week said it received FDA breakthrough device designation for its Selution SLR sustained limus release drug-eluting balloon catheter. Selution SLR is designed to treat atherosclerotic lesions in native coronary arteries. The breakthrough designation was awarded for its design of improving luminal diameter in patients with atherosclerotic lesions. Get the full story on our […]
Catheters
Medtronic launches DCB for dialysis patients in Japan
Medtronic (NYSE:MDT) this week said it launched its first drug-coated balloon in Japan for patients undergoing hemodialysis. The company launched its In.Pact AV drug-coated balloon, which is indicated for the treatment of obstructive lesions up to 100 mm in length in the native arteriovenous dialysis fistulae in patients with end-stage renal disease and undergoing hemodialysis. It […]
Medtronic launches IDE trial for AFib tech
Medtronic (NYSE:MDT) announced today that it conducted the first procedures of its Pulsed AF AFib treatment pivotal trial. The investigational device exemption (IDE) trial is evaluating the PulseSelect pulsed field ablation (PFA) system that uses pulsed electric fields to treat atrial fibrillation. The FDA granted the company approval to move forward with the IDE trial […]
The worst catheter-based device recalls of 2020
The U.S. saw nine serious medical device recalls related to catheters in 2020 — up from four the previous year, according to the FDA. FDA in 2020 reported a total 33 medical device recalls at its most serious Class I level, down from 49 in 2019. The list of the most serious catheter-based device recalls […]
FDA panel votes against BD Lutonix drug-coated balloon for below-the-knee
An FDA advisory panel voted against a favorable recommendation for BD‘s Lutonix catheter-based, drug-coated balloon for use below the knee. The FDA’s Circulatory System Devices Advisory Panel yesterday voted 15-to-2 in favor of the issue of safety when Lutonix is used as intended and voted 15-to-2 against the issue of a reasonable assurance of effectiveness. The […]
Smart urinary catheter company moves to Minneapolis, changes its name to UroDev
UroDev Medical, formerly known as Spinal Singularity, this week announced it appointed Matt Monarski as CEO and that it would be moving its headquarters to Minneapolis. Monarski joins the company with nearly 30 years of global commercial experience focused on advancing new urology, gynecology and orthopedic medical devices. Prior to joining the company, Monarski held […]
FDA: Penumbra recall of some Jet 7 catheters is serious
A Penumbra recall of certain Jet 7 catheters is Class I – the most serious type of recall, the FDA recently said. The recall, which Penumbra originally announced on Dec. 15, 2020, involved more than 30,000 distributed units of its Jet 7 Reperfusion Catheters with Xtra Flex Technology after the company received 14 reports of death related […]
Medtronic touts recently acquired Rist catheters for neurovascular procedures
Medtronic today announced an early site limited release of its recently acquired Rist radial access guide catheters. The Rist 079 catheter is designed for the introduction of interventional devices into the peripheral, coronary and neuro vasculature using the radial artery in the wrist. The Rist Radial Access Selective catheter is designed to introduce interventional devices […]
Medtronic wins FDA approval for DiamondTemp ablation system
Medtronic (NYSE:MDT) announced today that it received FDA approval for its DiamondTemp ablation (DTA) system for treating Afib. Fridley, Minn.-based Medtronic’s DiamondTemp ablation system treats patients with recurrent, symptomatic paroxysmal Afib who have been unresponsive to drug therapy. The medtech giant touts DiamondTemp as the first FDA-approved, temperature-controlled, irrigated radiofrequency ablation system with diamonds currently available […]
Ancora Heart says enrollment has started for AccuCinch pivotal trial
Ancora Heart this week said it has enrolled the first patient in its AccuCinch Ventricular Restoration System pivotal trial. AccuCinch is a flexible implant that is attached to the inner wall of the left ventricle and then cinched. It is designed to reduce the size of the left ventricle, reduce ventricular wall stress and support […]
The top 10 catheter innovations of 2020
As the COVID-19 pandemic took over the world in 2020, medical device companies continued to showcase new catheter innovations. Throughout 2020, we saw FDA clearances, approvals and product launches for a variety of catheter-based technologies, including renal denervation systems, heart failure treatment catheters, mechanical thrombectomy systems and more. The list includes some medtech giants like […]
