Varian wins FDA breakthrough nod for cardiac radioablation system


2021-05-27 04:00:11 Mass Device


Varian announced today that it received FDA breakthrough device designation for its cardiac radioablation (CRA) system. Palo Alto, Calif.-based Varian, a recently acquired Siemens Healthineers company, develops the CRA system as a noninvasive therapy for select patients with refractory ventricular tachycardia (VT), according to a news release. VT, a fast, abnormal heart rate that could lead to sudden cardiac arrest, can be treated with an implantable cardioverter-defibrillator (ICD), antiarrhythmic medications or an invasive catheter ablation procedure. Still, Varian says those methods are often insufficient in controlling VT. The Varian CRA system won the breakthrough nod because it could offer a more effective treatment for refractory VT through the noninvasive targeting and delivery of ablative energy across the full thickness of the myocardium, unlike conventional catheter ablation. Varian believes that if the planned clinical studies support its CRA approach, it could be possible to achieve better and safer outcomes requiring less time than current surgical modalities. “Early positive clinical results suggest that non-invasive cardiac radioablation could offer new hope for patients with refractory VT,” Varian president of proton solutions & growth office Kolleen Kennedy said in the release. “We look forward to developing this important new technology and working closely with the FDA to develop the appropriate clinical program for market approval.”
瓦里安公司今天宣布,其心脏放射消融(CRA)系统获得FDA突破性设备指定。 总部位于加利福尼亚州帕洛阿尔托的Varian公司最近收购了西门子Healthineers公司,根据一份新闻稿,该公司开发了CRA系统,作为一种非侵入性治疗顽固性室性心动过速(VT)患者的方法。 VT是一种快速、异常的心率,可导致心脏骤停,可通过植入式心律转复除颤器(ICD)、抗心律失常药物或侵入性导管消融治疗。然而,瓦里安说,这些方法在控制室速方面往往是不够的。 Varian CRA系统赢得了突破性的胜利,因为它可以通过非侵入性靶向性和跨心肌全层输送消融能量,为难治性室性心动过速提供更有效的治疗,而不是传统的导管消融。 Varian认为,如果计划中的临床研究支持其CRA方法,那么与目前的手术方式相比,它有可能获得更好和更安全的结果,所需时间更短。 “早期的积极临床结果表明,非侵入性心脏放射消融术可以为难治性室性心动过速患者提供新的希望,”Varian proton solutions&growth办公室的总裁Kolleen Kennedy在新闻稿中说。“我们期待着开发这一重要的新技术,并与FDA密切合作,开发出适合的临床项目供市场批准。”