相关临床试验
9
0 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
1943
已完成
4
44.4%
招募中
3
33.3%
Unknown
2
22.2%
暂无批准数据
- The FDA assigned a Class II severity rating to the recall of Medline's Hudson RCI neonatal and infant heated wire breathing circuits, placing it in the middle of the agency's three-tier risk system. - The recall stems from sporadic failures at the heated-wire connector, where circuits can discolor, melt, smoke, or emit a burning odor at the point of connection to the Neptune humidifier. - A built-in safety feature cuts power to the heated wires when electrical abnormalities are detected, so respiratory gas flow continues and only the warming and humidification function stops. - Medline reported no serious injuries or deaths associated with the issue as of July 31, though hospitals face a dual item-numbering problem that could cause affected stock to be missed.
- The FDA has approved Teleflex's EZPLAZ™ Freeze-Dried Plasma (FDP) for adult transfusion when conventional plasma products are unavailable. - EZPLAZ™ stores at room temperature (2–25°C) with a 12-month shelf life and reconstitutes in approximately 1–2.5 minutes, eliminating freezing and thawing requirements. - The approval comes amid a national blood supply crisis, with the American Red Cross reporting blood donations at a four-year low. - The product is manufactured from male-only donor plasma to mitigate TRALI risk and is available in blood group type AB or type A with low titer Anti-B.
- AVITA Medical's Board of Directors has appointed Cary Vance as President and Chief Executive Officer effective immediately, following his successful six-month tenure as Interim CEO since October 2025. - The appointment follows a thorough search process conducted with an international executive search firm, with the Board unanimously concluding that Vance is the right leader for the company's growth period. - Vance brings 30 years of healthcare executive experience and has demonstrated decisive leadership in stabilizing the business, sharpening strategic focus, and rebuilding confidence among employees, customers, and shareholders. - Jan Stern Reed has been elected as Chair of the AVITA Medical Board, bringing over 35 years of legal and business management experience in the healthcare industry.
- 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.
- Teleflex has enrolled the first patient in the DUBSTENT DIABETES trial, a randomized study evaluating a dual-device approach combining drug-coated balloons with drug-eluting stents for percutaneous coronary intervention in diabetic patients. - The 120-patient trial addresses the critical unmet need of higher stent failure rates in diabetic patients despite advances in drug-eluting stent technology. - The study will compare the combination therapy against single-device strategies using either drug-coated balloons alone or drug-eluting stents alone, with the primary endpoint being percentage diameter stenosis at six months. - Secondary endpoints include major cardiovascular events and quality of life measures tracked over five years, potentially shaping future treatment strategies for this high-risk patient population.
- Teleflex has launched Barrigel rectal spacer in Japan following regulatory approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), marking a key milestone in the company's global expansion strategy. - The hyaluronic acid-based device is the first and only sculptable non-animal stabilized hyaluronic acid rectal spacer proven to significantly reduce radiation reaching the rectum during prostate cancer treatment. - Clinical data shows 98 percent of treated men achieved at least a 25 percent reduction in rectal radiation exposure, with patients averaging an 85 percent reduction in rectal V54 Gy radiation. - The launch addresses a significant medical need in Japan, where prostate cancer was the most common cancer among men in 2022 with 104,318 new cases accounting for 18 percent of all cancer diagnoses nationwide.
- A multinational prospective cohort study of over 6,670 ICU patients across eight countries demonstrated a 70.5% reduction in central line-associated bloodstream infections (CLABSIs) with chlorhexidine-impregnated catheters compared to plain catheters. - The study found lower incidence of infection-causing pathogens including gram-negative bacteria, gram-positive bacteria, and fungi in patients using Arrowg+ard Blue and Arrowg+ard Blue Plus CVCs. - Despite patients with impregnated catheters having longer ICU stays and higher device utilization ratios, infection rates remained significantly lower, demonstrating effectiveness even in high-risk populations. - The research suggests unprotected CVCs may be an independent risk factor for CLABSI, even when proper insertion training and maximal barrier precautions are maintained across both groups.
- A new retrospective study published in Obesity Surgery demonstrates that Teleflex's Titan SGS™ Stapler significantly reduces post-operative GERD rates following sleeve gastrectomy compared to traditional multi-fire staplers. - The study of 257 patients showed only 7.1% of Titan SGS™ patients reported GERD at one-year post-procedure versus 26.4% in the multi-fire cohort, while maintaining equivalent weight loss outcomes. - Researchers attribute the improved outcomes to the stapler's 23cm single-fire continuous staple line, which creates more consistent and symmetrical sleeve anatomy without kinks that can cause narrowing.
- Teleflex's QuikClot Control+ Hemostatic Device received FDA 510(k) clearance for expanded use in all grades of internal and external bleeding, significantly broadening its clinical applications beyond severe bleeding scenarios. - The expanded indication was supported by real-world evidence from a rigorous observational study of 603 emergency, trauma, and surgical patients across multiple U.S. sites, demonstrating safety and efficacy. - This regulatory milestone is expected to add more than $150 million to Teleflex's serviceable addressable market in the United States, extending the device's use to general, gynecologic, and orthopedic surgeries.
- New clinical data presented at the 2025 AUA Annual Meeting shows the UroLift System provides better early patient satisfaction and faster symptom relief compared to Rezūm and tamsulosin for BPH treatment. - Two randomized controlled trials revealed UroLift patients experienced shorter catheterization times, better sexual function outcomes, and higher overall satisfaction during early recovery periods. - Real-world data from the American Urological Association Quality Registry confirms UroLift provides rapid symptom improvement at three months, reinforcing its position as a leading minimally invasive BPH treatment option.
