Medical Tubing and Extrusion

Medical tubing and extrusion technologies

CE Mark

Teleflex wins Breakthrough Device designation for Freesolve resorbable scaffold

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The Teleflex (NYSE: TFX) Freesolve RMS (resorbable magnesium scaffold) has won FDA Breakthrough Device designation for percutaneous coronary intervention (PCI). "Freesolve RMS has the potential to provide physicians with an additional treatment option, by reducing the need for permanent implants and potentially offering an alternative to … [Read more...] about Teleflex wins Breakthrough Device designation for Freesolve resorbable scaffold

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

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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

Medtronic wins expanded indication in Europe for Affera to treat VT

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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

Galaxy Therapeutics’ SEAL embolization system gets CE mark 

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By Julia Rock-Torcivia Galaxy Therapeutics, a privately held medical device company focused on the treatment of intracranial aneurysms, today announced that it has received CE mark for its SEAL Embolization System. The CE mark follows successful assessment by Notified Body DQS Medizinprodukte GmbH.  SEAL (which stands for Saccular … [Read more...] about Galaxy Therapeutics’ SEAL embolization system gets CE mark 

Penumbra earns CE mark for Thunderbolt thrombectomy system

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Penumbra (NYSE:PEN) announced today that it received CE mark approval for its Thunderbolt thrombectomy system for stroke. European approval for the computer-assisted vacuum thrombectomy (CAVT) technology comes just days after FDA clearance. Thunderbolt expands the company’s computer-assisted vacuum thrombectomy (CAVT) portfolio. It aims to … [Read more...] about Penumbra earns CE mark for Thunderbolt thrombectomy system

Gore wins CE mark for Fortegra venous stent

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W.L. Gore & Associates announced today that it received CE mark approval for its Viabahn Fortegra venous stent system. European approval comes about six months after the stent picked up FDA approval. The company labeled Viabahn Fortegra the first device for the treatment of deep venous disease in the inferior vena cava (IVC), iliac and … [Read more...] about Gore wins CE mark for Fortegra venous stent

BD picks up CE mark for next-gen stent graft

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BD (NYSE:BDX) announced today that it received CE mark approval for its Liverty TIPS stent graft system. Franklin Lakes, New Jersey-based BD designed the stent graft to expand treatment options for patients with cirrhosis and complications of portal hypertension. The next-generation, adjustable-diameter device marks the latest advancement for … [Read more...] about BD picks up CE mark for next-gen stent graft

Johnson & Johnson brings next-gen Varipulse PFA catheter to Europe

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Johnson & Johnson (NYSE:JNJ) announced today that it launched the Varipulse Pro system in Europe following CE mark approval. Varipulse Pro features a new pulse sequence that marks the next evolution of the pulsed field ablation (PFA) platform. The company said it designed the technology to improve procedural efficiency while reinforcing … [Read more...] about Johnson & Johnson brings next-gen Varipulse PFA catheter to Europe

MicroPort EP wins European approval for PFA catheter

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MicroPort EP announced today that it received EU MDR certification for its PulseMagic pulsed field ablation (PFA) catheter. The China-based company designed its PFA catheter to enhance both flexibility and performance in electrophysiology (EP) procedures. MicroPort says that PulseMagic enables both high-density mapping and PFA through one … [Read more...] about MicroPort EP wins European approval for PFA catheter

BD picks up CE mark for Revello vascular covered stent

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BD (NYSE: BDX) announced today that it received CE mark approval for its Revello vascular covered stent system. Franklin Lakes, New Jersey–based BD designed Revello to treat atherosclerotic lesions in the common and external iliac arteries. The next-generation endovascular solution combines the flexibility of a nitinol self-expanding stent with … [Read more...] about BD picks up CE mark for Revello vascular covered stent