Zeus Industrial Products has agreed to integrate catheter-based contract manufacturer CathX Medical into its organization. The financial terms of the agreement were not disclosed in yesterday's announcement. San Jose, Calif.–based CathX provides catheter design engineering services, rapid prototyping, manufacturing, and full or … [Read more...] about Zeus Industrial Products brings in CathX Medical
Zeus Industrial Products founder passes away
Frank Paul Tourville Sr. — who founded Zeus 54 years ago and built it into a major provider of advanced medical tubing products — recently passed away at age 87. The Orangeburg, S.C.–based company in its announcement of Tourville's March 16 death described him as a well-known and highly regarded visionary in the polymer extrusion … [Read more...] about Zeus Industrial Products founder passes away
Argon Medical Devices launches snare catheter
Argon Medical Devices (Frisco, Texas) today announced the U.S. launch of its Halo single-loop snare kits. The snare catheter's creators designed it to provide both accuracy and reliability when retrieving and manipulating foreign objects from the cardiovascular system or hollow viscus, according to Argon Medical Devices. "We are excited to … [Read more...] about Argon Medical Devices launches snare catheter
FDA committee to examine safety of endovascular stent grafts
FDA’s CDRH Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet later this year to examine the safety of endovascular stent grafts made by Endologix and other companies. Day one of the meeting will examine the benefit-risk profile of the Endologix AFX endovascular graft system regarding a potentially … [Read more...] about FDA committee to examine safety of endovascular stent grafts
FDA approves Medtronic’s Harmony transcatheter pulmonary valve system
FDA has approved a Medtronic device described as a first-in-the-world, non-surgical heart valve to treat severe pulmonary valve regurgitation — a condition often arising from congenital heart disease. The Harmony transcatheter pulmonary valve system could delay the time before someone with congenital heart disease might need additional … [Read more...] about FDA approves Medtronic’s Harmony transcatheter pulmonary valve system
Cook Medical wins FDA breakthrough device designation for next-gen endovascular graft
Cook Medical announced that FDA has granted breakthrough device designation for its Zenith Fenestrated+ endovascular graft (ZFEN+), the next-gen version of its Zenith Fenestrated AAA endovascular graft. The designation — a first for Bloomington, Ind.–based Cook Medical — will enable priority review and better communication with FDA during the … [Read more...] about Cook Medical wins FDA breakthrough device designation for next-gen endovascular graft
Alleviant Medical wins FDA breakthrough device designation for transcath heart failure treatment
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
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
Medtronic has a Class I recall involving balloon catheters to treat heart defects
FDA today designated a Medtronic recall of Rashkind balloon septostomy catheters as Class I, its most serious level. The balloon catheters create an atrial septal defect or to enlarge an existing atrial septal defect in order to treat congenital heart defects. Medtronic (NYSE:MDT) initiated a recall of the Rashkind balloon septostomy … [Read more...] about Medtronic has a Class I recall involving balloon catheters to treat heart defects
J&J wins FDA approval for ablation catheter
Johnson & Johnson (NYSE:JNJ) recently announced that its Biosense Webster business has secured FDA approval for its Thermocool SmartTouch SF ablation catheter. The Thermocool SmartTouch received approval for the treatment of persistent atrial fibrillation, J&J announced yesterday. The approval came after results from the 381-patient, … [Read more...] about J&J wins FDA approval for ablation catheter
