CavaClear
Philips IVC Filter Removal Laser Sheath
IVC filter removal
  • Life-changing IVC filter removal - Cindy's patient story
  • Labs will have access to dedicated Philips representatives to help train staff on device usage and mechanisms of action, as well as offer additional support.
  • CavaClear under fluoro
  • The FDA recommends that implanting physicians consider removing retrievable IVC filters as soon as they are no longer indicated.⁴ There has been no on-label solution for advanced retrieval techniques of embedded IVC filters, until now.
  • What is CavaClear? Watch now to find out.
  • Breakthrough Device Designation is an FDA program for innovative medical devices that provides a pathway for expedited review of a more effective treatment or diagnosis of life-threatening or permanently debilitating diseases.
  • Standard product photograph

CavaClear

Philips IVC Filter Removal Laser Sheath
IVC filter removal
Research has shown that IVC filters may have long-term complications and the FDA has published multiple safety communications recommending the removal of IVC filters when no longer indicated.¹,² Philips IVC Filter Removal Laser Sheath – CavaClear – is the first and only FDA-cleared solution for advanced IVC filter removal³ and was granted Breakthrough Device Designation (BDD). It is a state-of-the-art laser sheath designed to safely and predictably ablate scar tissue 360 degrees around an embedded IVC filter.⁴ CavaClear provides an effective, minimally invasive solution for embedded IVC filters, no matter the filter dwell time. CavaClear is backed by Philips support to train staff on device usage and mechanisms of action, as well as offer additional support to seamlessly integrate into your workflow.

Clinical image gallery

  • Laser mechanism of action does not damage the IVC filter.⁸
    Laser mechanism of action does not damage the IVC filter.⁸
Features
Safe
CavaClear has proven clinical success rates of 96-99.4% with a major adverse event rates of 0.7-2%.⁹,¹⁰
Safe
Efficient
Circumferential tissue ablation around the embedded IVC filter can easily capture the filter within seconds of laser activation.⁴
Efficient
Controlled
CavaClear requires 43.3% less force than standard retrieval techniques¹¹ and the mechanism of action does not damage the IVC filter.⁸
Controlled
Specifications
  • CavaClear IVC Filter Removal Laser Sheath 500-514
    Sheath size
    14 F
    Minimum tip inner diameter
    10.2 F / 0.134" / 3.40 mm
    Maximum tip outer diameter
    14.7 F / 0.192" / 4.88 mm
    Working length
    50 cm
    Repetition rate
    25-80 Hz
    Clinical energy setting
    30-60 mJ/mm
  • CavaClear IVC Filter Removal Laser Sheath 500-516
    Sheath size
    16 F
    Minimum tip inner diameter
    12.5 F / 0.164" / 4.17 mm
    Maximum tip outer diameter
    17.2 F / 0.225" / 5.72 mm
    Working length
    50 cm
    Repetition rate
    25-80 Hz
    Clinical energy setting
    30-60 mJ/mm

Documentation

CavaClear product brochure
PDF|3.00 MB

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Disclaimer
1. Van Ha, T. G. Complications of inferior vena caval filters. Semin. Interv. Radiol. 23,150–155 (2006).
2. Health, C. for D. and R. Safety Communications - Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication. (2014).
3. Office of the Commissioner. FDA Grants Marketing Authorization for Inferior Vena Cava Filter Removal Device [Press release]. https://www.fda.gov/news-events/press-announcements/fda-grants-marketing-authorization-inferior-vena-cava-filter-removal-device (2021).
4. Kuo, W. et al. The Excimer Laser Sheath Technique for Embedded Inferior Vena Cava Filter Removal. J Vasc Interv Radiol 2010; 21:1896-1899
5. 2021 DRG data calculation.
6. Internal data on ease of use D052981 Human Factors Study found all 19 participating physicians scored 5/5 to "I believe the laser sheath is easy to incorporate into an IVC filter removal workflow".
7. Desai KR, Kaufman J, Truong P, et al. Safety and Success Rates of Excimer Laser Sheath–Assisted Retrieval of Embedded Inferior Vena Cava Filters. JAMA Netw Open. 2022;5(12):e2248159. doi:10.1001/jamanetworkopen.2022.48159
8. D052155 DVR for Laser Energy Effects on IVC filters Project 1349.
9. 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).  
10. Desai, K. et al. Excimer Laser Sheath-Assisted Retrieval of “Closed-Cell” Design Inferior Vena Cava Filters. J Am Heart Assoc; 9: e017240 (2020).
11. Kuo WT, Odegaard JI, Rosenberg JK, Hofmann LV. Laser-assisted removal of embedded vena cava filters: a 5-year first-in-human study. Chest2017; 151:417–424.
12. CMS Grants Transitional Pass-Through (TPT) payment for CavaClear (Outpatient) https://www.cms.gov/regulations-and-guidance/guidance/transmittals/2023-transmittals/r12421cp
13. CMS Grants Transitional Pass-Through (TPT) payment for CavaClear (ASC) https://www.cms.gov/regulations-and-guidance/guidance/transmittals/2024-transmittals/r12439cp