“Laser-assisted filter retrieval may be a critical tool for the safe retrieval of filters with extended implantation times,” said Kush R Desai, MD, FSIR, Associate Professor of Radiology, Surgery, and Medicine, and Director of Deep Venous Interventions at Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA. “Breakthrough Device Designation reflects the potential impact that this technology could have on countless patients where this technology can be applied to safely retrieve filters by an expert physician, thereby reducing their risk of significant filter-related complications.”
“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,” said Atul Gupta, MD, Interventional Radiologist and Chief Medical Officer, Image Guided Therapy, at Philips. “Breakthrough Device Designation is an important step for a medical innovation such as this one to help fill an unmet need in patient care.”
FDA Breakthrough Device Designation is granted to novel medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal of the Breakthrough Devices Program is to provide patients and healthcare providers with timely access to breakthrough medical devices. Under the program, the FDA will provide Philips with priority review and interactive communication regarding device development throughout the submission process.
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 Health, C. for D. and R. Safety Communications - Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication. (2014). Available at: http://wayback.archive-it.org/7993/20170722215731/ https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm396377.htm.
 Kuo, W. et al. Laser‐Assisted Removal of Embedded Vena Cava Filters: A First‐In‐Human Escalation Trial in 500 Patients Refractory to High‐Force Retrieval. Journal of the American Heart Association 9:24, 1-9 (2020). https://www.ahajournals.org/doi/pdf/10.1161/JAHA.119.017916
 Desai, K. et al. Excimer Laser Sheath-Assisted Retrieval of “Closed-Cell” Design Inferior Vena Cava Filters. J Am Heart Assoc; 9: e017240 (2020).