CereVasc announced today that it opened a new manufacturing and research facility in Wilmington, Massachusetts. The new facility opening comes on the heels of two June milestones: the company’s $85 million Series C round and the completion of enrollment in the STRIDE pivotal trial of the eShunt system. CereVasc says the new location positions it […]
Nitinol Devices & Components
Cardiac Dimensions data highlights durability, performance of mitral annuloplasty device
Cardiac Dimensions announced today that it published three manuscripts providing new evidence supporting its Carillon mitral contour system. Kirkland, Washington-based Cardiac Dimensions’ data support the company’s device for transcatheter indirect mitral annuloplasty. The publications span a five-year, multi-center commercial registry, the largest single-center experience across both preserved and reduced ejection fraction, and long-term survival results […]
Peytant Solutions announces first human use of tracheobronchial covered stent system
Peytant Solutions today announced the first-in-human implantation of its AMStent tracheobronchial covered stent system. The implantation took place at Fairview East Bank University Hospital (M Health Fairview University of Minnesota Medical Center). Minneapolis-based Peytant said it marked the first clinical use of a nitinol stent covered with a human-sourced amniotic membrane. It hopes to redefine […]
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 track for topline data and continued progress […]
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 […]
CereVasc closes $85M Series C to support eShunt system with investment from J&J, Medtronic
CereVasc announced today that it completed the initial closing of an $85 million Series C financing round to support its eShunt system. Piper Sandler Merchant Banking led the financing round for the Boston-based company. Johnson & Johnson Innovation – JJDC, Inc., Johnson & Johnson’s corporate venture capital arm, and Medtronic also participated, as did existing […]
Edwards gets FDA nod for Triformis Resilia surgical tricuspid valve replacement
Edwards Lifesciences (NYSE:EW) said today that it received FDA approval for Triformis Resilia, its surgical tricuspid valve replacement. Irvine, California–based Edwards says it represents a significant approval for the first surgical tricuspid valve designed specifically for patients with tricuspid valve disease. The company said at the end of 2025 that it earmarked the second half […]
Zenflow findings back BPH treatment device
Zenflow recently shared data from its BREEZE pivotal clinical trial supporting the use of its Spring implant for benign prostatic hyperplasia (BPH). Outcomes demonstrated the safety and efficacy of the Spring implant and delivery system, which received FDA approval last year. Lead investigator Dr. Dean Elterman presented findings at the American Urological Association (AUA) annual […]
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 range of peripheral arterial vessel sizes. […]
Artivion closes $175M acquisition of aortic arch maker Endospan
Endospan announced today that Artivion completed its $175 million acquisition of the company, following FDA approval for its Nexus system. The FDA granted premarket approval (PMA) for the Nexus aortic arch system last month. Nexus treats aortic arch disease, including chronic aortic dissections, in patients at high risk for open surgical repair. The bi-modular off-the-shelf […]
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 to pick up an FDA nod related to […]
