Alleviant Medical (Austin, Texas) has received FDA breakthrough device designation for its no-implant, interatrial shunt technology for treating certain types of chronic heart failure. Founded in 2017, Alleviant's minimally invasive transcatheter tech decompresses the left atrium without a permanent cardiac implant or open-heart surgery. … [Read more...] about Alleviant Medical wins FDA breakthrough device designation for transcath heart failure treatment
Catheters
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
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
Cook Medical has a serious catheter recall
FDA has designated Cook Medical's recall of its Flexor Check-Flo introducers and Flexor tuohy-borst side-arm introducers as Class I, its most serious level. Cook Medical initiated the recall on Nov. 24. It involves 37,326 of the devices, which are used to deliver medical devices to blood vessels (though not vessels of the heart and brain). The … [Read more...] about Cook Medical has a serious catheter recall
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
SoniVie wins FDA breakthrough nod for renal denervation tech
SoniVie announced that it received FDA breakthrough device designation for its Tivus renal artery denervation technology. Tivus (therapeutic intra-vascular ultrasound system) is designed for treating resistant hypertension through renal artery denervation. The system previously received breakthrough designation for treating pulmonary arterial … [Read more...] about SoniVie wins FDA breakthrough nod for renal denervation tech
ReCor Medical gains FDA breakthrough nod for renal denervation system
ReCor Medical this week announced that its Paradise ultrasound renal denervation system won FDA breakthrough device designation following positive results in a study. The Palo Alto, Calif.-based company’s Paradise system is an investigational device that is designed to treat hypertensive patients who may not be sufficiently responsive to or are … [Read more...] about ReCor Medical gains FDA breakthrough nod for renal denervation system
Acutus Medical transseptal crossing wins CE mark
Acutus Medical today said it received CE mark approval for its transseptal crossing products. The device is designed to deliver safe and efficient access to the left atrium of the heart. It includes the company's AcQCross Qx with either the AcQGuide Mini or steerable AcQGuide Flex introducer sheath. AcQCross Qx features an integrated needle … [Read more...] about Acutus Medical transseptal crossing wins CE mark
Medical Ingenuities gains FDA nod for radial artery occlusion device
Medical Ingenuities today received FDA 510(k) clearance for its radial artery occlusion device called PH Band. PH Band provides real-time feedback to medical personnel monitoring radial artery patency to help prevent radial artery occlusion. It can be used in conjunction with a micro Doppler Probe to achieve patent hemostasis after a minimally … [Read more...] about Medical Ingenuities gains FDA nod for radial artery occlusion device
