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.*
愛德華生命科學（加拿大）公司今天宣佈，加拿大衛生部已批准該公司的PASCAL Precision經導管二尖瓣修復系統，用於經皮減少顯著的症狀性二尖瓣反流。
"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."
多倫多聖邁克爾醫院結構性心臟計劃主任、介入心臟病學家Neil Fam博士說：“受症狀性退行性二尖瓣反流（DMR）困擾的患者是一個龐大而且極爲缺乏服務的群體。在CLASP IID數據中，接受PASCAL系統治療的患者在功能能力和生活質量方面顯示出顯著改善，這種改善在研究期一年內持久下去。隨着PASCAL Precision經導管二尖瓣修復系統獲得批准，我們現在在加拿大治療嚴重的二尖瓣反流患者的選擇更加豐富。”
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系統具有獨立抓握、非創傷性鉗閉和拉伸的能力，爲患有DMR的患者提供安全有效的治療。該系統具有直觀的導管和手柄，設計靈活穩定，能夠精確導航和植入。
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關鍵試驗的數據是第一項直接比較兩種現代經導管邊緣對邊緣修復（TEER）療法的隨機對照試驗，證明PASCAL系統在患有DMR的廣泛人群中的臨床和生命質量方面具有MR減少的益處。35屆心血管介入治療研究基金會的轉導心血管治療學研討會於2023年10月公佈了CLASP IID隨機試驗的一年結果，並發表於《JACC：心血管介入》雜誌上，顯示PASCAL系統實現了：
- 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.
- 一年的嚴重不良事件自由率爲84.7%，
- 顯著且持久的MR減少，其中95.8%的患者在一年內達到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.
愛德華生命科學加拿大的總經理Frank Wuest表示：“PASCAL Precision系統是愛德華公司正在開發的多種經導管修復或置換療法之一，旨在治療二尖瓣疾病。愛德華致力於通過大量臨床證據，改變二尖瓣和三尖瓣患者的治療方式。”
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系統已獲得美國食品和藥物管理局（FDA）於2022年批准用於治療DMR，以及對治療二尖瓣和三尖瓣反流的CE標誌認證。