Latest news with #KCCQ
Yahoo
30-06-2025
- Business
- Yahoo
Foldax reports one-year outcomes from trial of TRIA mitral valve
Foldax has revealed one-year outcomes from the India Clinical Trial of the TRIA mitral valve. Presented at the Cardiovascular Research Foundation (CRF)-organised annual conference, New York Valves 2025, the results indicate a good safety profile and statistically significant patient quality-of-life improvements. The key findings from the trial include no deaths or reinterventions related to the valve, more than 50% decrease in mean gradient, and an increase of over 90% in effective orifice area. Additionally, patients experienced a 24-point improvement in their Kansas City Cardiomyopathy Questionnaire (KCCQ) score and a 65% increase in Six-Minute Walk Test distance, underscoring the valve's potential to enhance quality of life. The multi-centre, prospective trial enrolled 67 subjects between the ages of 19 and 67 across eight Indian sites. The company noted that 64% of the subjects were women and around half were of childbearing age. 73% of the subjects had rheumatic heart disease. Foldax CEO Ken Charhut said: 'These results validate our strategy of taking heart valve therapy to a new level by bringing innovation to a platform of products that will help patients globally.' Foldax aims to overcome the limitations of tissue and mechanical heart valves with its polymer heart valves, which are designed to be durable and potentially eliminate the need for lifelong anticoagulation. The LifePolymer used in TRIA valves is said to resist calcification, ensuring biostability and biocompatibility, preventing the requirement for animal-based components. The TRIA Mitral Valve is currently not available for commercial sale in the US as it is still under investigation. Earlier this month, the company secured approval from the Indian Central Drugs Standard Control Organization (CDSCO) for the valve, which will be locally manufactured by Dolphin Life Science. "Foldax reports one-year outcomes from trial of TRIA mitral valve" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
17-06-2025
- Business
- Yahoo
Corvia Medical raises $55m to complete confirmatory heart shunt trial
Corvia Medical has raised $55m to complete an ongoing clinical trial of its atrial shunt system for heart failure. The US-based company's trial began in 2022 and is currently underway at more than 65 institutions across three continents with 750 patients enrolled, according to the trial's listing on Increasing Corvia's current funding to around $150m, the latest set of funds originated from the company's existing investment syndicate of Third Rock Ventures, General Catalyst Partners, AccelMed, Lumira Ventures, along with two strategic investors. Corvia anticipates the double-blind, randomised, sham-controlled confirmatory RESPONDER-HF (NCT05425459) trial of the Corvia atrial shunt system, which is being evaluated to treat heart failure with preserved and mildly reduced ejection fraction (HFpEF/HFmrEF), to generate the final clinical data required to support a regulatory filing with the US Food and Drug Administration (FDA). The atrial shunt works by creating a small passage between the heart's left and right atria, enabling blood to flow from the high-pressure left side to the lower-pressure right side. Trial patients randomised to the treatment arm will undergo a fluoroscopically and intra-cardiac echocardiography (ICE), or transoesophageal echocardiography (TEE) guided trans-septal puncture and with the Corvia atrial shunt implant procedure. In addition, patients randomised to the control arm will undergo ICE from the femoral vein or TEE for examination of the atrial septum and left atrium. Upon completion, patients will be evaluated at pre-specified time intervals and followed for five years. Corvia CEO George Fazio said: "We are profoundly grateful for the unwavering support of our longstanding investors as we advance toward FDA submission of the Corvia atrial shunt. "Their commitment furthers our mission to bring this transformative heart failure treatment to millions of patients worldwide." The funding will provide Corvia with the resources needed to navigate the approval process for the Corvia shunt system and introduce the therapy to the market, added Corvia board chair Paul LaViolette. Research indicates that around 65 million people worldwide have heart failure, with a majority affected by HFpEF. In October 2023, Corvia announced positive safety and efficacy results from its REDUCE LAP-HF II (NCT03088033) randomised Phase III trial of its atrial shunt. In comparison to the sham control, patients showed a 50% reduction in the rate of heart failure events and a sustained improvement in quality of life as measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ). "Corvia Medical raises $55m to complete confirmatory heart shunt trial" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
