Abbott (NYSE: ABT) earned FDA approval for its new dual-energy catheter, TactiFlex Duo sensor-enabled ablation catheter. TactiFlex Duo joins Johnson & Johnson MedTech’s ThermoCool SmartTouch SF and Medtronic's Affera Sphere-9 catheter in the U.S. dual-energy ablation catheter market. Medtronic won its Sphere-9 approval in 2024, and J&J … [Read more...] about Abbott earns FDA approval for new dual-energy ablation catheter
Nitinol
CereVasc completes enrollment in eShunt trial
CereVasc announced today that it completed patient enrollment in the STRIDE pivotal trial evaluating its investigational eShunt system. Boston-based CereVasc said it completed enrollment at 32 clinical sites. Now, STRIDE continues to progress through remaining treatment and follow-up activities for consented patients. The company said it is on … [Read more...] about CereVasc completes enrollment in eShunt trial
Gore wins CE mark for Fortegra venous stent
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
Endologix acquires Pounce thrombectomy system from Surmodics
Endologix announced today that it acquired the Pounce thrombectomy system from Surmodics, closing the deal on May 18. Pounce, an FDA-cleared and commercially available fully mechanical thrombectomy platform, offers the non-surgical removal of thrombi and emboli from peripheral arteries. It comes in multiple configurations to support use across a … [Read more...] about Endologix acquires Pounce thrombectomy system from Surmodics
Prodeon gets FDA clearance for BPH-treating nitinol implant
Prodeon Medical announced today that it received FDA 510(k) clearance for its Urocross expander system. Sunnyvale, California-based Prodeon designed Urocross as a novel, non-permanent implant technology for treating lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). It marks the latest device of this kind … [Read more...] about Prodeon gets FDA clearance for BPH-treating nitinol implant
BD picks up CE mark for Revello vascular covered stent
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
CereVasc reports first-in-human use of eShunt for idiopathic intracranial hypertension
CereVasc today announced the first-in-human case report for the use of its eShunt system to treat medically refractory idiopathic intracranial hypertension (IIH). IIH, formerly known as pseudotumor cerebri, is characterized by elevated pressure around the brain without an identifiable structural cause. The condition is associated with chronic … [Read more...] about CereVasc reports first-in-human use of eShunt for idiopathic intracranial hypertension
St. Jude Medical founder Manny Villafaña looks to take Medical 21 venture public
Medical 21, the latest venture for a major figure in medtech, has filed a Form S-1 with the U.S. SEC to initiate the process of an initial public offering (IPO). Manny Villafaña founded Medical 21 in 2016, marking his latest venture after leading multiple big names in medtech. Villafaña founded, among others, CPI, which as acquired by Guidant … [Read more...] about St. Jude Medical founder Manny Villafaña looks to take Medical 21 venture public
ProVerum, Zenflow win FDA nods for BPH treatment devices
ProVerum and Zenflow this week announced FDA approvals for their technologies that treat benign prostatic hyperplasia (BPH). Dublin, Ireland-based ProVerum won approval for its ProVee system. Zenflow got the green light for its Spring implant and delivery system. Both companies aim to offer a potential treatment for BPH, a common urological … [Read more...] about ProVerum, Zenflow win FDA nods for BPH treatment devices
Merit Medical to launch Wrapsody endoprosthesis in U.S. after CMS defers reimbursement decision
Merit Medical Systems (Nasdaq:MMSI) announced that its application for reimbursement for its Wrapsody procedures requires further CMS consideration. As a result, the company plans to go ahead with the U.S. rollout for the cell-impermeable endoprosthesis (CIE). "We have elected to withdraw our application for TPT incremental payment and intend … [Read more...] about Merit Medical to launch Wrapsody endoprosthesis in U.S. after CMS defers reimbursement decision
