Dornier MedTech America announced the full U.S. commercial launch of two single-use devices, the Dornier Hoover Flexible and Navigable Suction Ureteral Access Sheath and the Dornier Axis II Slim ureteroscope. Both devices had already received FDA clearance and were in limited release before the full U.S. launch. The Hoover sheath provides … [Read more...] about Dornier MedTech launches new ureteral access sheath and ureteroscope in U.S.
Technologies & Devices
Abbott updates instructions for TactiFlex ablation catheter following instances of tip damage
The FDA today issued a notice warning of updated instructions for the Abbott (NYSE: ABT) TactiFlex Ablation Catheter, Sensor-Enabled (SE). According to the agency, Abbott issued a letter to affected customers recommending updated instructions when removing the catheter from its packaging. The communication comes as part of the FDA's Communications … [Read more...] about Abbott updates instructions for TactiFlex ablation catheter following instances of tip damage
Imperative Care reports positive outcomes with Symphony thrombectomy system in acute PE
Imperative Care today announced positive efficacy and safety results from its pivotal SYMPHONY-PE study. SYMPHONY-PE evaluates the company’s Symphony thrombectomy system in the treatment of acute pulmonary embolism (PE). Campbell, California-based Imperative Care designed Symphony, a large-bore aspiration catheter system, to deliver more … [Read more...] about Imperative Care reports positive outcomes with Symphony thrombectomy system in acute PE
Jupiter Endovascular wins FDA clearance for Vertex catheter
Jupiter Endovascular announced today that its Vertex catheter received FDA 510(k) clearance for the insertion of endovascular devices. According to the FDA 510(k) database, the agency received Jupiter Endovascular's submission on June 30. It delivered the clearance on Sept. 12. The company took to LinkedIn to announce the regulatory … [Read more...] about Jupiter Endovascular wins FDA clearance for Vertex catheter
MicroPort Cardio’s Alwide Plus balloon catheter wins CE mark
MicroPort CardioFlow said its Alwide Plus balloon catheter has received CE mark approval, clearing the company to market the device in Europe. The approval makes Alwide Plus the company’s fourth product authorized in Europe, following the VitaFlow Liberty transcatheter aortic valve and delivery system, and the AnchorMan left atrial appendage … [Read more...] about MicroPort Cardio’s Alwide Plus balloon catheter wins CE mark
J&J’s Shockwave launches Javelin IVL catheter in Europe
Johnson & Johnson MedTech‘s Shockwave Medical announced today that it launched its Javelin peripheral IVL catheter in Europe. The novel, non-balloon catheter comprises part of the company's first-of-its-kind forward intravascular lithotripsy (IVL) platform. It features a similar safety and effectiveness profile to legacy Shockwave IVL … [Read more...] about J&J’s Shockwave launches Javelin IVL catheter in Europe
Pulnovo earns duo of FDA IDE nods for hypertension treatment
Pulnovo Medical announced today that it received two FDA investigational device exemption (IDE) approvals for its technology. Shanghai-based Pulnovo won IDEs for its pulmonary artery denervation (PADN) catheter and generator. It can now evaluate its technology in studies for Group I and Group II pulmonary hypertension (PH) patients. With full CMS … [Read more...] about Pulnovo earns duo of FDA IDE nods for hypertension treatment
Teleflex enrolls first patient in dual-drug-eluting device study of coronary interventions for diabetes
Teleflex (NYSE:TFX) announced today that it enrolled the first patient in its DUBSTENT DIABETES trial. The randomized, investigator-initiated trial evaluates a dual-device strategy for percutaneous coronary intervention (PCI) in patients with diabetes mellitus. DUBSTENT DIABETES investigates the safety and efficacy of combining drug-coated … [Read more...] about Teleflex enrolls first patient in dual-drug-eluting device study of coronary interventions for diabetes
Abbott reports first commercial Tendyne mitral valve implant in the U.S.
An Abbott official announced on social media that doctors completed the first commercial implant of Tendyne in the U.S. Chris Waddell, Abbott’s U.S. VP for transcatheter aortic valve implantation (TAVI), posted the news on LinkedIn. It’s the latest milestone for Tendyne, a transcatheter mitral valve replacement (TMVR) system, after its FDA … [Read more...] about Abbott reports first commercial Tendyne mitral valve implant in the U.S.
Johnson & Johnson wins FDA nod for intravesical drug delivery tech
![The Inlexzo system. [Image courtesy of Johnson & Johnson]](https://www.medicaltubingandextrusion.com/wp-content/uploads/2025/09/Inlexzo-JJ-2-1-300x195.jpg)
Johnson & Johnson (NYSE:JNJ) announced today that the FDA approved Inlexzo, its gemcitabine intravesical drug delivery system. The intravesical gemcitabine-releasing system, previously known as TAR-200, treats patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle invasive bladder cancer (HR-NMIBC) with carcinoma in … [Read more...] about Johnson & Johnson wins FDA nod for intravesical drug delivery tech
