Intact Vascular’s Tack Endovascular System® Receives FDA Approval

Intact Vascular公司Tack Endovascular(血管内)系统®获FDA批准

2019-04-15 20:15:13 BioSpace


First-of-its-Kind Treatment for Post-Angioplasty Above-the-Knee Dissections Now Available WAYNE, Pa.--(BUSINESS WIRE)-- Intact Vascular, Inc., a private medical device company committed to developing solutions for minimally invasive peripheral vascular procedures, today announced it received U.S. Food and Drug Administration (FDA) approval for the Tack Endovascular System (6F), a purpose-built dissection repair device implanted post-angioplasty in patients with peripheral arterial disease (PAD). Regulatory approval was based on data from Intact Vascular’s Tack Optimized Balloon Angioplasty II (TOBA II) pivotal trial, which demonstrated the safety and effectiveness of the Tack® implant to resolve dissections following angioplasty. Data from the pivotal trial were presented in a late-breaking scientific session at the 2018 VIVA conference. “I look forward to having the Tack implant available for my patients,” said Dr. William Gray, System Chief, Division of Cardiovascular Disease at Main Line Health, President, Lankenau Heart Institute and Principal Investigator for the TOBA II trial. “Post-angioplasty dissections can significantly impact patient outcomes. Having a minimal metal solution that specifically addresses dissections and improves angioplasty results while preserving future treatment options is extremely exciting.” The inflation of an angioplasty balloon and resulting mechanical stress inherently injures vessels and creates dissections. These dissections are prevalent, underdiagnosed and underestimated1. If left untreated, dissections can compromise clinical outcomes, resulting in acute thrombosis and arterial occlusions, leading to lower long-term patency rates and repeat procedures. The TOBA II pivotal trial, notably the first peripheral vascular study to enroll patients with 100% dissected vessels, met all primary endpoints with 92% of dissections completely resolved following treatment. In this challenging patient population, the Tack® implant demonstrated 79.3% K-M vessel patency and 86.5% K-M freedom from clinically driven reintervention at 12 months, with only a 0.5% bailout stent rate and zero implant fractures. “FDA approval of the Tack Endovascular System comes at a dynamic time in the PAD market place. The Tack system’s unique combination of minimal metal and highly targeted dissection repair is an ideal fit with today’s focus on minimizing inflammation and improving long term outcomes,” stated Bruce Shook, President and CEO of Intact Vascular. He added, “Now with the Tack Endovascular System available in both Europe and the United States, we look forward to expanding our commercialization efforts and continuing to improve the quality of life for PAD patients.” Intact Vascular recently announced its European launch and first commercial cases in several centers across Germany. With FDA approval granted, the company plans a limited initial release in the US that will progress toward broader market commercialization.
膝关节上方血管成形术的首个可用治疗方法 宾夕法尼亚州,韦恩--- Intact Vascular是一家致力于开发微创外周血管手术解决方案的私营医疗器械公司,该公司今天宣布其Tack Endovascular(血管内) 系统(6F),用于植入外周动脉疾病患者的后血管成形术的特制解剖修复装置获FDA许可。 监管机构的批准基于 Intact Vascular's Tack 优化球囊血管成形术 II ( TOBA II )关键试验的数据,该试验证明了 Tack ®植入物在血管成形术后解决解剖的安全性和有效性。关键试验的数据在2018年 VIVA 会议的最新科学会议上发表。 “我期待着为我的病人提供 Tack 植入物,” William Gray 博士说,他是主线健康心血管疾病部门的系统负责人,兰肯瑙心脏研究所所长, TOBA II 试验首席研究员。“血管成形术后解剖可以显著影响患者的预后。有一个最小的金属溶液,专门解决解剖和改善血管成形术的结果,同时保留未来的治疗选择是非常令人兴奋的。” 血管成形术球囊膨胀和由此产生的机械应力必然会损伤血管,造成破裂。这些破裂是普遍存在的,且常常诊断不足和被低估。如果不及时治疗,这些破损可以损害临床结果,导致急性血栓和动脉闭塞,导致长期的低通畅率和重复程序。 TOBA II 关键试验,尤其是第一个将100%解剖血管的患者纳入的外周血管研究,在治疗后,92%的解剖完全解决了所有主要终点。在这一具有挑战性的患者群体中, Tack ®植入物在12个月内证明了79.3% K-M 血管通畅性和86.5% K-M 自由不受临床驱动的再通气,仅有0.5%的抢救支架率和零植入物骨折。 “ FDA对Tack Endovascular系统的批准正处于外周动脉疾病市场活跃的时期。Tack 系统的最小金属和高度针对性的解剖修复独特组合符合当下对最小化炎症和改善长期结果的关注,”Intact Vascular总裁兼首席执行官 Bruce Shook说道,“现在在欧洲和美国都可以使用Tack Endovascular系统,我们期待着扩大我们的商业化努力,并继续改善外周动脉疾病患者的生活质量。” Intact Vascular 最近在德国的几个中心宣布了其欧洲上市和首例商业案例。在获得 FDA 批准后,该公司计划在美国进行有限的首次发布,这将朝着更广泛的市场商业化迈进。