- FDA on Thursday released draft guidance for companies making 510(k) submissions for peripheral vascular atherectomy devices. The recommendations are intended to help manufacturers develop a risk analysis and performance testing strategy for devices used to remove plaque from diseased peripheral arteries. The document supplements FDA’s specific content requirements and recommendations for a 510(k) submission.
- The guidance covers the four main categories of atherectomy devices: directional, rotational, orbital and laser. Which device used depends on plaque location and quantity, vessel characteristics and physician experience.
- FDA said the guidance could be applied to a new atherectomy device that might not fall into one of the four main categories, but does not cover devices involving use of a guidewire to treat chronic total occlusions or devices used for plaque modification.
Peripheral arterial disease (PAD) is thought to affect more than 10 million people in the United States but is underdiagnosed, according to the Society for Cardiovascular Angiography and Interventions. It involves the build-up of fatty deposits in the artery walls, typically in the lower limbs, and can lead to life-threatening blood clots.
An atherectomy procedure uses a catheter, typically with a sharp blade on the end, to remove plaque from a blood vessel. Medtronic and Boston Scientific are among the companies that make atherectomy devices.
The procedure can involve either cutting, shaving, sanding or vaporizing the plaque, depending on the device. Atherectomy is preferred for treating blockages in arteries that occur around branches or in vessels that are not easily treated with stents.
FDA’s new draft guidance for atherectomy devices includes recommendations for device comparisons, labeling, biocompatibility, sterility, hazard analysis, animal testing models, clinical performance testing, study endpoints and labeling.
Atherectomy is also used in treating coronary arterial disease, but devices intended for such procedures are classified as Class III due to the higher-risk anatomical location and require a premarket approval application before marketing, FDA said.