Clinical Trials
77
1 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Completed
65
84.4%
No Longer Available
1
1.3%
Not yet recruiting
1
1.3%
Terminated
7
9.1%
Unknown
2
2.6%
Withdrawn
1
1.3%
No approval data available
- The FDA has approved Cordis' SELUTION SLR drug-eluting balloon for coronary in-stent restenosis, the first and only sirolimus-coated balloon cleared in the United States. - Approval rests on the SELUTION4ISR trial, which enrolled more than 400 patients across 48 sites and met its 12-month primary endpoint of non-inferiority versus standard of care. - In all randomized patients, target lesion failure occurred in 15.2% of SELUTION SLR recipients versus 13.5% with standard of care, which included 80% drug-eluting stents. - Cordis has also completed enrollment in the 960-patient SELUTION4DeNovo IDE trial testing the balloon against drug-eluting stents in small-vessel de novo lesions.
- A new sub-study from the SELUTION DeNovo trial demonstrates that sirolimus-eluting balloons (SEB) can safely reduce the need for permanent stents in patients with non-ST-elevation myocardial infarction and unstable angina. - The study analyzed 1,089 patients and found similar one-year outcomes between SEB with minimal stenting and traditional drug-eluting stents, with target vessel failure rates of 5.3% versus 4.9% respectively. - This "Leave-Nothing-Behind" strategy potentially reduces long-term complications associated with permanent metal implants, which affect 1-4% of patients annually. - The findings support using drug-coated balloons as an effective alternative treatment approach that preserves arterial structure while maintaining therapeutic efficacy.
- Cordis has launched the SELUTION SLR PTA Drug-Eluting Balloon in Japan, marking the first sirolimus-eluting balloon approved for peripheral artery disease treatment in the country. - The SELUTION SFA Japan clinical trial demonstrated impressive three-year outcomes with 81.5% primary patency and 93.8% of patients remaining free from reintervention. - The device features Sustained Limus Release technology designed to provide controlled sirolimus delivery over 90 days to reduce restenosis and restore vessel function. - Cordis will present additional clinical data from the SELUTION4ISR and SELUTION DeNovo coronary trials at CRT 2026, including 12-month outcomes and procedural experience analyses.
- Haemonetics will acquire Ireland-based Vivasure Medical for €100 million upfront, with potential additional payments of €85 million based on sales milestones. - The acquisition brings Vivasure's PerQSeal Elite biosorbable patch system, which received CE mark approval for venous closure and has a pending FDA premarket approval application. - The deal strengthens Haemonetics' position in the $300 million large-bore closure market, particularly for structural heart procedures like transcatheter aortic valve replacement. - Vivasure's technology complements Haemonetics' existing vascular closure devices and expands capabilities for fast-growing endovascular procedures.
- November 2025 marks 25 years since the FDA approved vascular brachytherapy for treating in-stent coronary artery restenosis, a condition that can re-narrow arteries after stent placement. - The breakthrough began with pioneering research in 1994 by Dr. Paul Teirstein at Scripps Clinic and Dr. Ron Waksman at Emory University, using Iridium-192 seeds in nylon ribbons. - Both the Novoste Beta-Cath System and Cordis's Iridium-192-based therapy received FDA approval on November 3, 2000, making vascular brachytherapy officially available for clinical use. - Best Vascular/Novoste continues as a global leader in vascular brachytherapy and is expanding applications while inviting collaboration on new VBT advancements.
- Cordis has initiated the SELUTION Global Coronary Registry, which will track real-world outcomes of their sirolimus-eluting balloon in up to 10,000 patients worldwide for five years. - The registry complements five ongoing randomized trials and builds on positive peripheral experience data, positioning SELUTION SLR as a next-generation technology that delivers sustained drug release without permanent implants. - A distinguished steering committee of international interventional cardiologists will oversee the registry, including Dr. Ajay Kirtane from Columbia University as chairman.
- Cordis's SELUTION SLR Drug-Eluting Balloon demonstrated remarkable 81.5% primary patency at 3 years in the Japan Trial, establishing it as the only sirolimus-eluting technology with core-lab adjudicated 3-year patency exceeding 80%. - The SUCCESS PTA Study showed consistent effectiveness across 723 real-world patients, with freedom from clinically-driven target lesion revascularization reaching 91.1% overall at 12 months, including strong results in both claudicant and CLTI populations. - The sirolimus MicroReservoir technology in SELUTION SLR offers advantages over paclitaxel-based alternatives, with investigators noting "unprecedented durability" and "unequivocal clinical benefits" for complex peripheral artery disease patients.
- Endovascular Engineering has raised $42 million in Series B funding, co-led by 415 Capital and S3 Ventures, to advance their Hēlo PE Thrombectomy System for treating pulmonary embolism. - The company's innovative Hēlo Thrombectomy System combines powerful aspiration with mechanical clot disruption, delivering large-bore performance through a small-profile catheter for efficient clot removal. - The funding will support completion of the ENGULF pivotal trial evaluating the Hēlo PE System, positioning the company to establish a new standard of care in mechanical thrombectomy for pulmonary embolism.
