Edwards Lifesciences PASCAL Precision Transcatheter Valve Repair System Receives Health Canada Approval For Significant, Symptomatic Mitral Regurgitation
Edwards Lifesciences PASCAL Precision Transcatheter Valve Repair System Receives Health Canada Approval For Significant, Symptomatic Mitral Regurgitation
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.*
爱德华生命科学（加拿大）公司今天宣布，加拿大卫生部已批准该公司的PASCAL Precision经导管二尖瓣修复系统，用于经皮减少显著的症状性二尖瓣反流。
"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."
多伦多圣迈克尔医院结构性心脏计划主任、介入心脏病学家Neil Fam博士说：“受症状性退行性二尖瓣反流（DMR）困扰的患者是一个庞大而且极为缺乏服务的群体。在CLASP IID数据中，接受PASCAL系统治疗的患者在功能能力和生活质量方面显示出显著改善，这种改善在研究期一年内持久下去。随着PASCAL Precision经导管二尖瓣修复系统获得批准，我们现在在加拿大治疗严重的二尖瓣反流患者的选择更加丰富。”
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.
PASCAL Precision系统具有独立抓握、非创伤性钳闭和拉伸的能力，为患有DMR的患者提供安全有效的治疗。该系统具有直观的导管和手柄，设计灵活稳定，能够精确导航和植入。
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:
CLASP IID关键试验的数据是第一项直接比较两种现代经导管边缘对边缘修复（TEER）疗法的随机对照试验，证明PASCAL系统在患有DMR的广泛人群中的临床和生命质量方面具有MR减少的益处。35届心血管介入治疗研究基金会的转导心血管治疗学研讨会于2023年10月公布了CLASP IID随机试验的一年结果，并发表于《JACC：心血管介入》杂志上，显示PASCAL系统实现了：
- 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.
- 一年的严重不良事件自由率为84.7%，
- 显著且持久的MR减少，其中95.8%的患者在一年内达到MR≤2+。
"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.
爱德华生命科学加拿大的总经理Frank Wuest表示：“PASCAL Precision系统是爱德华公司正在开发的多种经导管修复或置换疗法之一，旨在治疗二尖瓣疾病。爱德华致力于通过大量临床证据，改变二尖瓣和三尖瓣患者的治疗方式。”
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.
PASCAL Precision系统已获得美国食品和药物管理局（FDA）于2022年批准用于治疗DMR，以及对治疗二尖瓣和三尖瓣反流的CE标志认证。