IVC Filter Safety Data Transparency Questioned in New Analysis
• A recent analysis highlights concerns regarding the safety data of inferior vena cava (IVC) filters, devices implanted to prevent blood clots.
• The analysis points to potential flaws in the clinical trial design that may have obscured critical safety issues with the IVC filter.
• Lack of transparency from both the FDA and device manufacturers regarding safety data raises concerns about patient safety and informed consent.
Study Exposes Risks of Cook Medical's Celect Filter and FDA Transparency Gaps
• A study reveals significant safety risks associated with Cook Medical's Celect filter, designed to prevent blood clots from reaching the lungs.
• Internal documents from Cook Medical omitted substantial risks, including deaths and serious complications, during the FDA approval process.
• Yale Law School's Media Freedom and Information Access Clinic (MFIA) played a crucial role in unsealing documents related to the Celect filter.
• The study highlights the need for greater transparency in medical device regulation and the importance of public access to critical health information.
Zenflow Secures $24 Million to Advance Minimally Invasive BPH Treatment
• Zenflow has raised $24 million in Series C funding to support the FDA Pre-Market Approval (PMA) submission for its Spring System, a BPH treatment.
• The Spring System is designed to alleviate urinary obstruction by gently propping open the urethra, preserving natural anatomy and function.
• Clinical trial data demonstrates promising outcomes in symptom relief, urinary flow rates, and preservation of sexual function, with a strong safety profile.
• Cook Medical's investment reflects confidence in Zenflow's technology and commitment to providing patient-friendly BPH treatment options.
Profound Medical Reports Strong Q3 Revenue Growth Driven by TULSA-PRO Adoption
• Profound Medical announced a 64% revenue increase in Q3 2024 compared to Q3 2023, driven by the adoption of its TULSA-PRO® system.
• The company's TULSA-PRO system is being utilized for a diverse range of prostate disease patients, including those with prostate cancer and BPH.
• CMS has raised TULSA reimbursement to Urology Level 7 APC, enhancing physician and patient access to this innovative therapy.
• Profound Medical is transitioning to a traditional medtech business model with capital and consumable sales, following positive reimbursement news.
Endospan Completes Enrollment in TRIOMPHE Trial for NEXUS Aortic Arch Stent Graft
• Endospan has concluded enrollment in the primary arm of the TRIOMPHE study, evaluating the NEXUS stent graft for aortic arch disease treatment.
• The NEXUS device, already CE marked in Europe, aims to provide a less invasive, off-the-shelf solution for complex aortic arch pathologies.
• The TRIOMPHE trial, conducted across 30 US and one New Zealand site, will monitor patient safety and efficacy for one year.
• Early trial results suggest the NEXUS stent graft demonstrates safety in high-risk surgical patients, potentially revolutionizing aortic arch disease treatment.
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