Cagent Vascular announced that it received FDA 510(k) clearance for its Serranator percutaneous transluminal angioplasty (PTA) serration balloon catheter. The FDA indication is for use of the Serranator for treating below-the-knee (BTK) lesions, making it the first and only angioplasty balloon with FDA clearance and CE Mark approval that embeds … [Read more...] about Cagent Vascular wins FDA clearance for balloon catheter
Could these DIY ventilators stop coronavirus from killing people?
Amid the global crisis caused by the coronavirus pandemic, hospitals and healthcare facilities are reporting shortages of vital equipment that not only keeps the patients safe, but the staffers, too. One important device for which demand has ramped up is ventilators for patients who need assistance with their breathing due to the respiratory … [Read more...] about Could these DIY ventilators stop coronavirus from killing people?
Boston Scientific has a Class I recall of angiographic catheters
The FDA has issued a Class I designation for a recall involving the Imager II 5F angiographic catheters produced by Boston Scientific (NYSE:BSX). Marlborough, Mass.-based Boston Scientific’s catheters are designed to provide a pathway for delivering contrast agents to blood vessels including carotid arteries. Get the full story at our sister … [Read more...] about Boston Scientific has a Class I recall of angiographic catheters
LeMaitre Vascular recall of embolectomy catheters is Class I
The FDA identified the recall of LeMaitre Vascular (NSDQ:LMAT) Over the Wire embolectomy catheters for a failure to deflate as a Class I recall. Burlington, Mass.–based LeMaitre Vascular's Over the Wire embolectomy catheter is indicated for use in the surgical removal of blood clots that are lodged in a blood vessel (emboli) and blood clots that … [Read more...] about LeMaitre Vascular recall of embolectomy catheters is Class I
Teleflex warns on Arrow multi-lumen catheter
Teleflex (NYSE:TFX) this week initiated a voluntary field safety corrective action in Europe for its Arrow subsidiary's multiple-lumen catheter. In a field safety notice dated March 16, Teleflex announced that Arrow is voluntarily recalling the catheter due to a potential sterility issue. The catheter's product tray may be damaged in affected … [Read more...] about Teleflex warns on Arrow multi-lumen catheter
Abbott wins CE Mark for FlexNav delivery system
Abbott (NYSE:ABT) announced today that it won CE Mark approval in Europe for the FlexNav delivery system for its Portico transcatheter aortic valve implantation (TAVI) system. The Abbott Park, Ill.-based company’s FlexNav delivery system is designed to offer another tool for doctors to treat patients requiring a transcatheter aortic valve … [Read more...] about Abbott wins CE Mark for FlexNav delivery system
Ablative Solutions touts study of its infusion catheter for renal denervation
Ablative Solutions announced today that it received positive results at six months from its post-market study for the Peregrine System infusion catheter, which accomplishes renal denervation by delivering microdoses of dehydrated alcohol. The results from the study of the safety and efficacy of the CE-Marked Peregrine System have been published … [Read more...] about Ablative Solutions touts study of its infusion catheter for renal denervation
Bluegrass Vascular Technologies wins de novo nod for ‘inside-out’ vascular access catheter
Bluegrass Vascular Technologies announced that it won FDA de novo clearance for its Surfacer inside-out access catheter system. The Surfacer is designed to obtain central venous access through its inside-out approach, facilitating catheter insertion to the central venous system in people with upper body venous occlusions or other conditions that … [Read more...] about Bluegrass Vascular Technologies wins de novo nod for ‘inside-out’ vascular access catheter
Is it possible to ‘knit’ replacement blood vessels?
A new way to replace a patient's damaged blood vessels may be on its way, as researchers in France are figuring out a way to "knit" new vessels with a collagen-based extracellular matrix. Inserm researcher Nicolas L'Heureux and his colleagues at Inserm/Université de Bordeaux's tissue bioengineering unit published a study in Acta Biomaterialia to … [Read more...] about Is it possible to ‘knit’ replacement blood vessels?
FDA clears Rist Neurovascular radial artery catheter
Rist Neurovascular announced today that it won FDA 510(k) clearance for its Rist Cath radial access long sheath for accessing the neurovasculature through the radial artery in the wrist. The Miami Beach, Fla.–based company touts the Rist Cath as the first device specifically designed to access the neurovasculature through the radial artery, … [Read more...] about FDA clears Rist Neurovascular radial artery catheter
