Philips Receives De Novo FDA Clearance for IVC Laser Filter Removal Sheath – CavaClear – with Revolutionary Device Designation


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22 December 2021

  • Philips IVC Filter Removal Laser Sheath – CavaClear – is for safe tissue ablation to remove encrusted IVC filters
  • CavaClear is a premier FDA approved solution for advanced IVC filter removal
  • It is estimated that in the United States, more than one million patients with IVC filters would benefit from filter removal to reduce the risk of long-term complications. [1,2]
  • Two independent and prospective clinical studies have shown laser assisted recovery to be 96-99.4% effective with a major adverse event rate of 0.7-2%. [3,4]

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Amsterdam, Netherlands –
Philips Royal (NYSE: PHG, AEX: PHIA), a global leader in healthcare technology today announced that the FDA has granted De Novo clearance for the Philips IVC Filter Removal Laser Sheath – CavaClear – to remove a filter IVC when previous withdrawal methods have failed. CavaClear is the first and only FDA approved solution for advanced IVC filter removal. Earlier in 2021, the FDA granted the device Designation of the revolutionary device . Laser has been clinically proven to provide over 99% success rate, with low complication rates [3].

IVC filters are used to treat patients with venous thromboembolism, in which blood clots form in the deep veins of the leg and groin, and may travel through the circulatory system. They are placed in the inferior vena cava to prevent blood clots from traveling to the lungs. However, research has shown that IVC filters can have long-term complications. [5]. Filters can fracture and travel through the bloodstream to other parts of the body. Other identified long-term risks associated with IVC filters include deep vein thrombosis of the lower extremities and occlusion of the IVC. FDA advises implant physicians to consider removing salvageable IVC filters as soon as they are no longer indicated [2].

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Failure rates for IVC filter removal can be high and prior to CavaClear, removal options were limited if the filter became difficult to remove. Advanced recovery tools and techniques are required if the IVC filter becomes embedded in the vascular system. Previously, doctors had very few tools to remove the filter in the event of complications, and until now there has been no FDA-approved device for this type of advanced removal.

“Today is a historic day. With the approval of CavaClear, physicians now have a device specifically designed to remove chronically integrated IVC filters, ”said Kush R. Desai MD, FSIR, associate professor of radiology, surgery and medicine and director of procedures deep veins at Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA. “Based on the evidence, this technology can be applied to recover IVC filters that are no longer indicated, thereby reducing the potential clinical risk to patients and meeting FDA guidelines for recovering filters when they are no longer needed. indicated. ”

Clinical research supports laser assisted removal

Two independent and prospective clinical studies have shown laser assisted recovery to be 96-99.4% effective with a major adverse event rate of 0.7-2%. [3,4]. Philips CavaClear uses circumferential tissue ablation which can help capture the filter within seconds of activating the laser, which can help increase the doctor’s efficiency during removal and can help cut costs by reducing the number of retrieval attempts required to remove a built-in filter. Plus, the simple and secure design is easy for physicians to integrate into their workflow.

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“With the FDA approval of our laser sheath for IVC filter removal – CavaClear – over one million patients and their physicians now have access to a safe, effective and efficient option for advanced IVC filter removal” said Chris Landon, senior vice president and general manager of image guided therapy devices at Philips. “This clearance demonstrates Philips’ commitment to innovate procedures with the collaboration of physicians to address unmet needs that can have a critical impact on the lives of patients and their families. “

[1] Calculation of Philips internal market research data.
[2] Health, C. for D. and R. Safety Communications – Removal of Retrievable Inferior Vena Cava Filters: FDA Safety Communication. (2014) .
[3] Kuo, W. et al. Laser-assisted removal of integrated vena cava filters: a first human escalation trial in 500 patients refractory to high force recovery. Journal of the American Heart Association 9:24, 1-9 (2020).
[4] Desai, K. et al. Excimer laser sheath assisted recovery of “closed cell” inferior vena cava filters. J Am Heart Assoc; 9: e017240 (2020).
[5] Van Ha, TG Complications of inferior vena cava filters. Semin. Interv. Radiol. 23, 150-155 (2006).

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For more information, please contact:

Joost maltha
Philips Global Press Office
Phone: +31 6 10 55 8116
E-mail: [email protected]

Fabienne van der Feer
Philips Image Guided Therapy
Phone: + 31 622 698 001
E-mail: [email protected]

About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading healthcare technology company focused on improving the health and well-being of people and achieving better results in the The entire health continuum, from a healthy lifestyle to prevention, including diagnosis, treatment and home care. Philips leverages cutting-edge technology and in-depth clinical and consumer information to deliver integrated solutions. Based in the Netherlands, the company is a leader in diagnostic imaging, image guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated sales of 17.3 billion euros in 2020 and employs around 78,000 people with sales and services in more than 100 countries. You can find news about Philips at www.philips.com/newscenter .

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