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 CavaClear IVC Filter Removal Laser Sheath is the first and only FDA-cleared solution for advanced IVC filter removal [3] 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] thereby reducing or minimizing the risks of complications often seen with chronically
implanted filters. CavaClear provides an effective, minimally invasive solution for embedded IVC filters, no matter the filter dwell time.
First and only FDA-cleared solution for advanced IVC filter removal [3]
Promotes safety by reducing mechanical forces needed during IVC filter removal [5]
Predictability with a success rate of up to 99% and low complication rates [6,7]
Features
Proven for complex removals
Philips CavaClear can help deliver relief to patients who have embedded filters—with a low risk of complications. CavaClear demonstrated 96-99.4% clinical success and 0.7-2% [6,7] major adverse event rate. By using cool ultraviolet laser energy around the embedded IVC filter, it can assist in fast filter retrieval with low required force.
Efficiency meets certainty
Philips CavaClear requires 43% less force than basic removal techniques [5], with a success rate of up to 99.4% [6]. Circumferential tissue ablation has
been shown to capture embedded IVC filters with less than one minute of laser activation. [4]*
Less force, more control
With a beveled tip and laser mechanism of action that requires 43.3% less force than standard retrieval techniques [5] and
does not damage the IVC filter [8], Philips CavaClear can enhance your control in removal procedures. It’s a simple, safe design that’s easy to learn and integrate into your workflow.
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
Related products
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. 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.
6. Desai, K. et al. Excimer Laser Sheath-Assisted Retrieval of “Closed-Cell” Design Inferior Vena Cava Filters. J Am Heart Assoc; 9: e017240 (2020).
7. Kuo, W. et al. Laser-Assisted Removal of Embedded Vena Cava Filters: A FirstIn- Human Escalation Trial in 500 Patients Refractory to High-Force Retrieval. Journal of the American Heart Association 9:24, 1-9 (2020).
8. D052155 DVR for Laser Energy Effects on IVC filters Project 1349.
*Based on one single-center study (n=23) and one multicenter study (n=49). Results reflect those study experiences
and may not be representative of all clinical settings. Individual outcomes may vary