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The Food and Drug Administration has recently approved the marketing of a laser-based device used for removing Inferior Vena Cava (IVC) filters. This device is specifically used in patients with an IVC filter. The filter is a small-cage like product that is placed into the largest vein of the body, in order to seize blood clots and avoid them from travelling to the lungs. Device is called as Philips CavaClear Laser Sheath, used for retrieval of IVC filters when other methods have failed.
Challenges and concerns
Previous methods have limited success in removing chronically embedded filters, that often led to complications related to the procedures. According to the M.D director of Cardiovascular devices, with the adoption of this novel device adverse outcomes can be avoided. Physicians will provide effective treatment outcomes as the device will allow safe removal of IVC filters. Moreover, complications can be prevented.
It highlights the role of FDA in analysing the true utility of devices with respect to equipment’s safety and effectiveness.
The Philips CavaClear Laser Sheath device
This device is useful to remove the firmly adherent IVC filters via ultraviolet laser energy. The laser detaches the filter from the IVC wall along with a small piece of tissue. The device works as an adjunct to conventional snare device used for removing IVC filters.
IVC filters and uses
These filters are generally used to manage patients with a higher risk for pulmonary embolism, especially if the treatment with anti-coagulants proves to be ineffective.
Some IVC filters can be placed permanently, however FDA reports safety concerns in a report published in 2014. According to this report, adverse events were recognised that prompted the FDA to recommend the physicians to remove the filters at the earliest once blood clots get resolved. As there is no risk to the patient in future.
FDA evaluated the effectiveness and safety of this device in a retrospective clinical study. The study included 265 patients from seven different clinical sites. Laser assisted filter removal was performed that demonstrated a success rate of 96%. 3% of the patients reported device-related adverse events such as filter breakage, hematoma formation and IVC injury resulting in bleeding.
The Philips CavaClear Laser Sheath device should not be used in the following situations:
- In presence of a blood clot within the filter or surrounding veins
- IVC filter is inaccessible
- Filter is non-metal
- Device should be avoided during removal of VenaTech IVC filters and Bird’s Nest IVC filters
The Philips CavaClear Laser Sheath has become a revolutionary device for removing IVC filters, such that it is granted a Breakthrough Device Designation.
The Breakthrough Devices Program is dedicated to creating new devices that have the potential to provide effective treatment outcomes, diagnose or timely identify debilitating medical conditions.
FDA has provided market authorization to Phillips. With the arrival of Philips CavaClear Laser Sheath, physician can safely remove the IVC filters and ensure that quality care is provided to the patients