Medical Tubing and Extrusion

Medical tubing and extrusion technologies

Applications

Cordis earns FDA nod for Selution SLR drug-eluting balloon

By

Cordis earned FDA approval for its Selution SLR (sustained limus release) drug-eluting balloon (DEB) to treat coronary in-stent restenosis, the device developer announced today. “As the first and only sirolimus drug-eluting balloon approved in the United States, Selution SLR  DEB introduces a groundbreaking therapy for the treatment of coronary … [Read more...] about Cordis earns FDA nod for Selution SLR drug-eluting balloon

XCath Robotics receives FDA breakthrough nod for Iris system

By

XCath Robotics has FDA Breakthrough Device Designation for its in-development Iris surgical robotic system for mechanical thrombectomy to treat acute ischemic stroke. Houston-based XCath says the designation provides increased opportunities to interact with FDA experts and receive support during the regulatory development and review process for … [Read more...] about XCath Robotics receives FDA breakthrough nod for Iris system

Luma Vision wins expanded FDA nod for its cardiac procedure software

By

Luma Vision has won FDA clearance to expand the capabilities of its Verafeye cardiac ablation procedure intelligence platform. The privately held, Dublin, Ireland–based medtech plans to launch commercially in early 2027. The news comes about six months after the company said it was expanding its clinical programs after submitting to the … [Read more...] about Luma Vision wins expanded FDA nod for its cardiac procedure software

Edwards Lifesciences, Medtronic score CMS win over TAVR

By

Edwards Lifesciences (NYSE: EW) and Medtronic (NYSE: MDT) are among the medtech companies praising CMS’s decision to expand Medicare coverage for TAVR to people with asymptomatic severe aortic stenosis. The finalized national coverage decision, published yesterday evening, also removes the evidence development (CED) requirement for symptomatic … [Read more...] about Edwards Lifesciences, Medtronic score CMS win over TAVR

Corcym achieves first-in-human implant of TriMemo for tricuspid valve repair

By

Corcym today announced that Cleveland Clinic doctors performed the first-in-human implantation of TriMemo, a semi-rigid ring designed to repair the tricuspid valve. The ring comprises three layers: a carbon film coating over the oval silicone sheath, which together guard the laser-cut nitinol cell structure. Nitinol, a superelastic … [Read more...] about Corcym achieves first-in-human implant of TriMemo for tricuspid valve repair

Medtronic says Endurant stent graft’s new CE mark could boost use for ruptured AAA

By

Medtronic (NYSE: MDT) has secured a CE mark for its Endurant stent graft, removing a treatment warning related to its use in ruptured abdominal aortic aneurysms (AAA). The Minnesota-run medtech giant received a similar FDA labeling change in late 2025. A ruptured AAA occurs when the main artery in the abdomen bursts, causing severe internal … [Read more...] about Medtronic says Endurant stent graft’s new CE mark could boost use for ruptured AAA

Boston Scientific discontinues Imager II angiographic catheter sales

By

Boston Scientific recalled and discontinued all Imager II angiographic catheters due to a manufacturing issue, according to an FDA early alert. Imager II angiographic catheters are diagnostic intravascular catheters used to capture images of the patient’s peripheral vasculature. Boston Scientific determined the catheters were “manufactured … [Read more...] about Boston Scientific discontinues Imager II angiographic catheter sales

MicroPort covered stent system receives special review in China

By

MicroPort Coronary announced that its FireShield coronary covered stent system will undergo the National Medical Products Administration (NMPA) special review procedures in China. The special review procedures aim to accelerate review for innovative medical devices that meet criteria for domestic originality, technical novelty and clinical … [Read more...] about MicroPort covered stent system receives special review in China

Jupiter Endovascular appoints Catalin Toma as chief medical officer 

By

Jupiter Endovascular, an endovascular interventions developer, has appointed interventional cardiologist Dr. Catalin Toma as chief medical officer, a new role for the company. Toma brings clinical and research experience across the structural heart and interventional landscape to his new role with Jupiter Endovascular, the company said … [Read more...] about Jupiter Endovascular appoints Catalin Toma as chief medical officer 

Medtronic wins expanded indication in Europe for Affera to treat VT

By

Medtronic (NYSE: MDT) has won an expanded CE mark indication for its Affera mapping and ablation system with Sphere-9 catheter to treat ventricular arrhythmias. The expanded indication, announced today, includes ventricular tachycardia (VT) and premature ventricular complexes (PVCs). According to Medtronic, the Sphere-9 catheter is the first … [Read more...] about Medtronic wins expanded indication in Europe for Affera to treat VT