The FDA has authorized the first laser-based device to remove IVC filters, developed by Koninklijke Philips NV (NYSE:PHG).
- Authorization was given through the de novo pathway, with Philips’ device receiving FDA breakthrough device designation for removing IVC (inferior vena cava) filters.
- Philips designed the device for patients who have an IVC (inferior vena cava) filter inserted into the largest vein in the body to capture blood clots and prevent them from traveling to the lungs.
- Related content: Benzinga's Full FDA Calendar.
- Philips’ CavaClear laser sheath removes tissue to facilitate the detachment of an IVC filter during retrieval when previous removal methods have failed.
- Philips designed the device to facilitate the detachment of the firmly adherent IVC filters from the IVC wall using ultraviolet laser energy to remove a small amount of the tissue.
- FDA said it assessed the safety and effectiveness of the CavaClear device through a clinical study of 265 patients.
- The study demonstrated a procedural, technical success rate of 96%, with a 3% rate of significant device-related complications.
- Price Action: PHG shares are up 1.49% at $35.33 during the market session on the last check Wednesday.
