St. Michael's Hospital

TORONTO, July 12, 2024 /CNW/ - Edwards Lifesciences (Canada) Inc today announced Health Canada's approval of the company's PASCAL Precision transcatheter valve repair system for the percutaneous reduction of significant, symptomatic mitral regurgitation.* "Patients suffering with debilitating symptoms due to symptomatic degenerative mitral regurgitation (DMR) represent a large and significantly underserved group," said Dr Neil Fam, Interventional Cardiologist and Director of the Structural Heart Program at St Michael's Hospital, Toronto. "In the CLASP IID data, patients receiving the PASCAL system experienced significant improvements in functional capacity and quality of life that were sustained for the one year of the study period. With the approval of the PASCAL Precision transcatheter valve repair system, we now have a new efficient option for treating patients with severe mitral regurgitation in Canada." The PASCAL Precision system, with its independent grasping, atraumatic clasp and closure, and ability to elongate, enables safe and effective treatment for patients with DMR. Engineered with an intuitive catheter and handle, the system is designed for maneuverability and stability, enabling precise navigation and implant delivery. Data from the CLASP IID pivotal trial, the first randomized controlled trial to directly compare two contemporary transcatheter edge-to-edge repair (TEER) therapies, confirm the clinical and quality-of-life benefits of MR reduction with the PASCAL system in a broad population of patients with DMR. One-year results from the CLASP IID randomized trial, presented at the 35th Transcatheter Cardiovascular Therapeutics symposium of the Cardiovascular Research Foundation in October 2023, and published in JACC: Cardiovascular Interventions, showed the PASCAL system achieved: Freedom from major adverse events rate of 84.7 percent at one year, and Significant and sustained MR reduction, with 95.8 percent of patients achieving MR ≤2+ at one year. "The PASCAL Precision system is one of multiple transcatheter repair or replacement therapies in development by Edwards that are designed to address mitral valve disease. Edwards is committed to transforming the treatment of mitral and tricuspid patients, supported by a robust body of clinical evidence," said Frank Wuest, Managing Director for Edwards Lifesciences in Canada. The PASCAL Precision system received US Food & Drug Administration (FDA) approval for the treatment of DMR in 2022, in addition to CE mark certification for the treatment of both mitral and tricuspid regurgitation. About TEER Transcatheter Edge-to-Edge Repair (TEER) of the mitral valve is used in the treatment of mitral regurgitation. TEER approximates the anterior and posterior mitral valve leaflets by grasping them with a clipping device in an approach similar to a treatment developed in cardiac surgery called the Alfieri stitch. * Indications for Use The PASCAL Precision transcatheter valve repair system is indicated for the percutaneous reduction of significant, symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus (degenerative MR) in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the MR. About Edwards Lifesciences Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakeholders across the global healthcare landscape. For more information, visit Edwards.com. Edwards, Edwards Lifesciences, the stylized E logo, CLASP, Edwards PASCAL, Edwards PASCAL Precision, PASCAL, and PASCAL Precision are trademarks of Edwards Lifesciences Corporation and its affiliates. All other trademarks are the property of their respective owners. This statement is made on behalf of Edwards Lifesciences Corporation and its subsidiaries. SOURCE Edwards Lifesciences

Semaglutide, a medication initially developed for type 2 diabetes and obesity, significantly improves symptoms in men and women with a common type of heart failure that has had few therapeutic options. Women experienced greater weight loss and the same symptom benefits compared with men. Semaglutide, a medication initially developed for type 2 diabetes and obesity, significantly improves symptoms in men and women with a common type of heart failure that has had few therapeutic options. Women experienced greater weight loss and the same symptom benefits compared with men, according to research presented today by Dr. Subodh Verma (St. Michael's Hospital, University of Toronto) at the American Diabetes Association's 2024 Scientific Sessions and published in the Journal of the American College of Cardiology (JACC). This secondary analysis of the STEP-HFpEF (Semaglutide Treatment Effect in People with Obesity and HFpEF) program reveals that semaglutide provides benefits for men and women that do not track directly with weight loss, suggesting the drug may also have weight-loss independent effects on the cardiovascular system. The study (which included two trials) compared semaglutide with a placebo over 52 weeks in 1,145 participants, highlighting intriguing sex differences. The analysis sought to determine whether phenotypic features and treatment effects of semaglutide vary by sex in obesity-related heart failure (HF) with preserved ejection fraction (HFpEF). It evaluated the influence of sex on the disease's baseline characteristics and compared the effects of semaglutide versus placebo on key trial endpoints in the STEP-HFpEF program (comprised of STEP-HFpEF and STEP-HFpEF DM Trials). "Understanding the sex differences in obesity-related HFpEF is of great importance. Obesity and visceral adiposity are key drivers of HFpEF development and progression, and this may be even more amplified in women, who represent the majority of people with the disease, and bear a heavier burden of symptoms and physical limitations due to HFpEF" said Mikhail Kosiborod, MD, FACC, senior author of the study and a cardiologist at Saint Luke's Mid-America Heart Institute in Kansas City, Missouri. "Our study sheds light on these differences and the consistent benefits of semaglutide for women and men." Lead author, Dr. Subodh Verma commented that "women living with obesity and heart failure with a preserved ejection fraction were also found to have higher BMI's compared to men, and were much more symptomatic at baseline." "Females had more systemic inflammation and compared to previous HfpEF studies, females with obesity-related HfpEF were also younger," Verma said. The study analyzed the effects of semaglutide 2.4 mg administered to participants once weekly vs placebo on the STEP-HFpEF program's dual primary and confirmatory secondary, and exploratory outcomes by sex. A total of 1,145 participants with obesity-related HFpEF were evaluated over 52 weeks, of which 570 were females. Semaglutide, compared with placebo, similarly improved HF-related symptoms, physical limitations, exercise function, and reduced inflammation and natriuretic peptides regardless of sex. Semaglutide-mediated improvements in HF-related symptoms and physical limitations were consistent in both male and female participants across key subgroups including age and BMI. It also lowered their systolic blood pressure and waist circumference. However, there were sex differences in the treatment effects in terms of the reduction in body weight with semaglutide. Female participants experienced greater weight loss than males, with a mean difference of -9.6% vs -7.2%. Even though there was a significant reduction in body weight in both sexes, it was greater in females (a statistically significant interaction). At baseline, females had higher left ventricular ejection fraction, presented with worse symptoms and physical limitations, and had higher levels of inflammation at baseline, but similar rates of hypertension and diuretic use and less atrial fibrillation compared with males, despite their higher BMI. Researchers note that this may indicate that more female participants had a typical obesity phenotype of HFpEF compared with males who may also have left atrial myopathy HFpEF complicated by an increase in BMI. In an accompanying editorial, Anuradha Lala, MD, a cardiologist at the Mount Sinai School of Medicine and Director of Heart Failure Research for the NHLBI Cardiothoracic Surgery Network, said there is a need for further studies to illuminate the mechanism by which this drug provides benefits and continued attention to sex-specific differences in treatment responses.

PARIS, April 24, 2024 /PRNewswire/ -- Cure51, a Techbio company seeking to unlock the biological mechanisms responsible for exceptional survivors among cancer patients, is proud to announce its latest partnership with Unity Health Toronto, a leading healthcare provider and research institution based in Canada. This collaboration marks a significant milestone in Cure51's mission to revolutionize cancer research and treatment. As the newest addition to Cure51's extensive network of over 50 medical partners globally, Unity Health Toronto brings a wealth of expertise and resources to the project. With a shared commitment to advancing medical innovation and improving patient outcomes, this partnership is poised to drive groundbreaking discoveries in the field of oncology. Cure51 is building the first global clinical and multi omics database of exceptional survivors with over 1100 patients from all continents and ethnic origins. Rather than follow the traditional route for therapeutics development, which typically isolates and studies the source of the ailment, Cure51 is taking a radically new approach, and studying patients who survive more than 3 to 5 years after diagnosis of a lethal disease without a medically valid explanation. So-called 'Outliers' patients are extremely rare, numbering only a few tens of thousands globally. Therefore, it is essential to broaden collaborations at both the national and global levels. "Cure51 is thrilled to welcome Unity Health Toronto to our growing network of medical partners," said Simon Istolainen, Cure51 co-founder and Chief Strategy and Scientific Network Officer. "Unity Health's reputation for excellence in patient care and research aligns perfectly with our mission to develop innovative solutions for cancer treatment. This is a strong testimony to our commitment towards adding more medical centers in North America. Together, we will harness the power of collaboration to accelerate the pace of discovery and bring hope to patients worldwide." Unity Health Toronto operates three major hospitals – St. Michael's Hospital, St. Joseph's Health Centre, and Providence Healthcare – each renowned for its commitment to compassionate care and groundbreaking research. Cure51 is focused on three aggressive forms of cancer: Extensive Stage Small Cell Lung Cancer, Glioblastoma and Metastatic Pancreatic Ductal Adenocarcinoma. The vision is to create a new paradigm for drug research and discovery, decoding survival mechanisms thus solving pharma's riskiest and most time-consuming challenges while creating a viable roadmap to save thousands of human lives. The company recently raised €15 million in Seed funding. CONTACT: Clara Armand-Delille, [email protected] Logo - SOURCE Cure51