Simpson Interventions Inc. has been accepted into the Total Product Life Cycle Advisory Program Pilot (TAP Pilot) by the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH).

辛普森干预公司已被美国食品和药物管理局（FDA）设备和放射健康中心（CDRH）接受为总产品生命周期咨询计划试点（TAP试点）。

Only devices granted Breakthrough Device designation by the FDA can apply for TAP Pilot Program enrollment. The voluntary program aims to help ensure U.S. patients have access to high-quality, safe, effective, medical devices by promoting early, frequent, and strategic communications between the FDA and medical device sponsors.

只有FDA授予突破性设备指定的设备才能申请TAP试点项目注册。该自愿项目旨在通过促进FDA和医疗器械赞助商之间的早期、频繁和战略性沟通，帮助确保美国患者获得高质量、安全、有效的医疗器械。

The FDA designated Simpson Intervention’s Acolyte Catheter System as a Breakthrough Device earlier this year..

今年早些时候，FDA指定辛普森干预公司的Acolyte导管系统为突破性设备。。

The Acolyte Catheter System helps physicians place and position guidewires and catheters within the coronary vasculature when treating patients suffering from coronary chronic total occlusions (CTOs) with persistent symptoms. By providing real-time visualization of coronary CTOs, the Acolyte Catheter System allows for precise guidewire placement and subsequent revascularization, improving patient outcomes and enhancing the standard of care, according to the company..

Acolyte导管系统有助于医生在治疗患有持续症状的冠状动脉慢性完全闭塞（CTO）患者时，将导丝和导管放置在冠状动脉脉管系统内。据该公司称，通过提供冠状动脉CTO的实时可视化，Acolyte导管系统可以精确放置导丝和随后的血运重建，改善患者预后并提高护理标准。。

'Simpson Interventions is honored to be accepted into the FDA's TAP Pilot Program for our Acolyte Catheter System,' Simpson Interventions Founder/CEO Dr. John B. Simpson, Ph.D., M.D., said. 'This acknowledgment underscores the innovative nature of the device and its potential to address an unmet medical need in interventional cardiology.

辛普森干预公司创始人/首席执行官约翰·辛普森博士（JohnB.Simpson）说，辛普森干预公司很荣幸能被FDA的TAP试点项目接受，用于我们的Acolyte导管系统这一承认强调了该设备的创新性质及其解决介入心脏病学中未满足的医疗需求的潜力。

We look forward to working closely with the FDA to advance the development and commercialization of this breakthrough technology.'.

我们期待着与FDA密切合作，推动这项突破性技术的开发和商业化。”。

Simpson Interventions is a medical technology company committed to addressing unmet clinical needs in cardiovascular diseases through technological innovations in visual-guidance, enhanced intelligence, and electromechanical automation for minimally invasive percutaneous intervention. The firm is headquartered in Campbell, Calif.

Simpson Interventions是一家医疗技术公司，致力于通过视觉引导，增强智能和机电自动化方面的技术创新来解决心血管疾病未满足的临床需求，以进行微创经皮介入治疗。该公司总部位于加利福尼亚州坎贝尔。