A Medical Device Daily

FoxHollow Technologies (Redwood City, California) reported plans to conduct a clinical study of its NightHawk Plaque Excision System under an Investigational Device Exemption application and to forego a previously 510(k) notification submitted to the FDA.

Assuming FDA approval, FoxHollow said it hopes to begin a U.S. clinical study to gain "important insight and experience" evaluating the NightHawk's ability to estimate the location of the catheter to the vessel wall during peripheral plaque excision. It said that the 510(k) sought approval for "a more limited set" of claims. It said it believes that a clinical trial "will facilitate use of the device among a group of experienced SilverHawk users in the U.S." sooner than if it had waited for a 510(k) approval.

The NightHawk combines optical coherence tomography (OCT) with the company's FDA-cleared SilverHawk System. The SilverHawk Plaque Excision System is a minimally invasive method of removing obstructive plaque and restoring blood flow to the legs and feet.

The NightHawk device utilizes fiber optic technology embedded in the catheter, allowing the physician to visualize the vascular morphology and wall structures within the artery. OCT imaging is designed for use as an adjunct to conventional angiography during plaque excision procedures.

FoxHollow also markets the Rinspirator System for removing thrombus from occluded arteries in patients suffering from PAD or coronary artery disease.