Zeus today announced it named Suresh Sainath as its new chief technology officer, effective immediately. The chief technology officer position is newly created, and Sainath will lead the Orangeburg, S.C.-based polymer extrusion and catheter manufacturing company's efforts to accelerate innovation and leverage the advanced capabilities of its … [Read more...] about Zeus names first chief technology officer
The top catheter-based innovation news stories of 2024 — so far
Catheter innovations have had a remarkable year so far, with many receiving regulatory approval as they prepare to enter the market. The pulsed field ablation market heated up in 2023 and continues to make waves this year with more companies entering the space. Intravascular lithotripsy is having its moment as well – Shockwave Medical was … [Read more...] about The top catheter-based innovation news stories of 2024 — so far
Smiths Medical issues urgent field safety notice for some Portex tracheotomy tubes
ICU Medical’s Smiths Medical this week issued an urgent field safety notice for some of its Portex Blue Line siliconized PVC tracheotomy tubes. The company issued the warning due to an issue related to the neck plate or flange of the Portex Blue Line siliconized PVC tracheotomy tubes. The failure mode can happen during use as a complete or … [Read more...] about Smiths Medical issues urgent field safety notice for some Portex tracheotomy tubes
Concept Medical wins FDA IDE for MagicTouch AVF drug-coated balloon
Concept Medical today announced it received FDA investigational device exemption for its MagicTouch AVF Sirolimus drug-coated balloon (DCB) catheter. The IDE allows the Tampa, Florida-based company to start a clinical study to treat stenotic lesions of arteriovenous fistula (AVF) in the hemodialysis management of chronic renal failure. "This … [Read more...] about Concept Medical wins FDA IDE for MagicTouch AVF drug-coated balloon
Getinge, Cook Medical sign U.S. commercial distribution agreement for iCast covered stent
Getinge and Cook Medical today announced they signed a commercial distribution agreement for the iCast covered stent system in the U.S. In this deal, Cook Medical will take over sales, marketing, and distribution rights for the product in the U.S. The iCast covered stent system will continue to be manufactured by Atrium Medical, a Getinge … [Read more...] about Getinge, Cook Medical sign U.S. commercial distribution agreement for iCast covered stent
Cook Medical signs distribution agreement with Bentley for BeBack catheter
Cook Medical today announced it signed a U.S. distribution agreement with Bentley for the BeBack catheter. Under the agreement, Cook Medical will assume commercial responsibilities for this Bentley product. “We are excited to welcome Bentley’s BeBack catheter to our peripheral intervention portfolio,” Alec Cerchiari, director of product … [Read more...] about Cook Medical signs distribution agreement with Bentley for BeBack catheter
ProVerum completes enrollment in ProVIDE clinical study for ProVee BPH treatment device
ProVerum this week announced it completed enrollment in its ProVIDE pivotal clinical trial to evaluate the safety and effectiveness of the ProVee system. The ProVIDE clinical trial is a prospective, multicenter, double-blind controlled study that evaluates the safety, performance, and effectiveness of the ProVee system in patients with lower … [Read more...] about ProVerum completes enrollment in ProVIDE clinical study for ProVee BPH treatment device
Cook Medical’s shorter Liver Access and Biopsy Set wins expanded indication
Cook Medical this week announced its shorter Liver Access and Biopsy Set (LABS) received pediatric indication. LABS was originally intended for use in adults, but was recently FDA cleared for use in adolescents, children and infants. The Bloomington, Indiana-based company designed the device for use in obtaining liver histology samples via … [Read more...] about Cook Medical’s shorter Liver Access and Biopsy Set wins expanded indication
PulseCath wins CE mark for iVAC 2L percutaneous mechanical circulatory support device
PulseCath this week announced it received CE mark approval for its iVAC 2L percutaneous mechanical circulatory support device. The iVAC 2L device helps facilitate high-risk percutaneous coronary interventions. PulseCath designed it to pump blood from the left ventricle to the aorta in synchronization with the natural rhythm of the patient's … [Read more...] about PulseCath wins CE mark for iVAC 2L percutaneous mechanical circulatory support device
Pentax Medical’s i20c video endoscopes wins CE mark
Pentax Medical this week announced it received CE mark approvals for new models of its i20c video endopscope series. The approval covers the Pentax Medical Video Colonoscope EC34-i20c, Pentax Medical Upper GI Scope EG27-i20c and the R/L Knob Adaptor OE-B17. Pentax Medical's i20c Video Endoscope Series, when used with the Inspira Video … [Read more...] about Pentax Medical’s i20c video endoscopes wins CE mark