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 to the … [Read more...] about FDA: Penumbra recall of some Jet 7 catheters is serious
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 … [Read more...] about Medtronic touts recently acquired Rist catheters for neurovascular procedures
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 and strengthen … [Read more...] about Ancora Heart says enrollment has started for AccuCinch pivotal trial
5 innovations to make duodenoscopes more single-use — and save lives
Duodenoscopes are important medical devices that are used for endoscopic retrograde cholangiopancreatography (ERCP) procedures. However, the devices have had serious problems in the past. Luckily, several medical device companies have stepped in to solve the problems. (Here are five of the innovations.) Duodenoscopes are flexible, lighted … [Read more...] about 5 innovations to make duodenoscopes more single-use — and save lives
Reflow Medical launches low-profile reinforced support catheters
Reflow Medical today announced it has launched its Reflow Spex Low Profile reinforced support catheters. The Spex LP catheters are designed to provide the lowest profile tip to access and cross the tightest and most complex lesions with a supportive system. They come in 0.014 in. and 0.018 in. sizes and can be combined with the Reflow Spex … [Read more...] about Reflow Medical launches low-profile reinforced support catheters
TechnoMed is rebranding to Tecnoideal America
TechnoMed this week announced that is rebranding to become Tecnoideal America, effective Jan. 12. The Derwood, Md.-based company's name change is part of its larger initiative to establish a local presence in North and South America. Tecnoideal America will build its local technical capabilities with technical experts to serve customers on … [Read more...] about TechnoMed is rebranding to Tecnoideal America
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 … [Read more...] about The top 10 catheter innovations of 2020
Concept Medical lands FDA breakthrough nod for MagicTouch catheter
Concept Medical this week said it received breakthrough device designation for its MagicTouch SCB sirolimus coated balloon catheter. The catheter is designed to treat small coronary artery lesions in coronary artery disease. The breakthrough device designation is indicated for percutaneous transluminal coronary angioplasty of small coronary … [Read more...] about Concept Medical lands FDA breakthrough nod for MagicTouch catheter
Penumbra recalls some Jet 7 catheters after 14 deaths
Penumbra (NYSE:PEN) has issued an urgent voluntary recall of all configurations of its Jet 7 Reperfusion Catheters with Xtra Flex Technology because the catheter may become susceptible to distal tip damage during use. So far, Alameda, Calif.-based Penumbra has received 14 reports of death related to the problem out of the more than 30,000 … [Read more...] about Penumbra recalls some Jet 7 catheters after 14 deaths
Polygon Composites names CEO
Polygon Composites recently announced that it appointed Randy Rice as CEO. Rice has more than 30 years of experience in diverse markets and industries. He most recently served as VP of Signode, the transit packaging division of Crown Holdings. "Randy brings a proven track record in collaborative team building and company growth through key … [Read more...] about Polygon Composites names CEO
