Philips wins breakthrough nod for laser-assisted IVC filter removal device


2021-07-22 13:00:45 Mass Device


Royal Philips (NYSE:PHG) announced today that it received FDA breakthrough device designation for its laser-assisted IVC filter removal device. Amsterdam-based Philips designed its laser-assisted inferior vena cava (IVC) filter removal device to ablate tissue to remove an IVC filter when previous methods of removal have failed, according to a news release. IVC filters are used for the treatment of venous thromboembolism, with placement in the inferior vena cava to capture blood clots from moving to the heart or lungs. Such filters can have long-term complications, so the FDA recommends that implanting physicians consider removing retrievable IVC filters as soon as they are no longer indicated. According to Philips, the failure rate for such removal is high and limited options exist if the filter becomes difficult to remove. Dr. Kush R. Desai — associate professor of radiology, surgery & medicine & director of deep venous interventions at Northwestern University’s Feinberg School of Medicine — said in the release that the FDA breakthrough nod “reflects the potential impact” Philips’ IVC filter removal technology could have. “There is a clear need for an innovative device to help physicians more safely perform advanced IVC filter removal, and I believe that the Philips excimer laser sheath may greatly enhance the options available to succeed in filter retrieval,” Philips CMO of image-guided therapy Dr. Atul Gupta said in the release.  “Breakthrough device designation is an important step for a medical innovation such as this  one to help fill an unmet need inpatient care.”
皇家飞利浦(纽约证券交易所代码:PHG)今天宣布,其激光辅助下腔静脉滤器去除设备获得了FDA突破性设备指定。 根据一份新闻稿,总部位于阿姆斯特丹的飞利浦公司设计了其激光辅助下腔静脉滤器去除装置,当以前的去除方法失败时,该装置可以消融组织以去除下腔静脉滤器。 下腔静脉滤器用于治疗静脉血栓栓塞,放置在下腔静脉以捕获移动到心脏或肺的血凝块。这种滤器可能有长期并发症,所以FDA建议植入医生一旦不再表明可回收的IVC滤器,就考虑删除它们。 根据飞利浦的说法,这种拆除的失败率很高,如果过滤器变得难以拆除,选择有限。西北大学范伯格医学院放射学、外科和医学副教授兼深静脉干预主任库什·德赛博士在新闻稿中说,美国食品和药物管理局的突破性点头“反映了飞利浦的IVC过滤器去除技术可能产生的潜在影响”。 飞利浦图像引导治疗CMO Atul Gupta博士在新闻稿中说:“显然需要一种创新的设备来帮助医生更安全地执行先进的IVC过滤器去除术,我相信飞利浦准分子激光鞘可能会大大增强过滤器回收的成功选择。”“突破性设备设计是像这样的医疗创新的重要一步,有助于满足未满足的住院护理需求。”