CavaClear
Philips IVC Filter Removal Laser Sheath
CavaClear
Philips IVC Filter Removal Laser Sheath
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.
First and only FDA-cleared solution for advanced IVC filter removal³
Promotes safety by reducing mechanical forces needed during IVC filter removal¹¹
Predictability with a success rate of up to 99% and low complication rates⁹,¹⁰
Clinical image gallery
- 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
JAMA publishes first multi-center study on laser-assisted IVC filter removal
Multicenter study proves laser technique safe and effective, regardless of varied laser experience. The average filter dwell time is 5 years across a variety of filter types with a 3% device-related major complication rate and a 96% technical success rate.
Efficient
Circumferential tissue ablation around the embedded IVC filter can easily capture the filter within seconds of laser activation.⁴
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
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