News | April 02, 2007

FoxHollow Submits NightHawk Peripheral Visualization System to FDA

April 3, 2007 —FoxHollow Technologies Inc. has announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration for its NightHawk Plaque Excision System. The intended use of the NightHawk System is in the evaluation of peripheral vascular morphology.

The NightHawk System brings together optical coherence tomography (OCT) technology with the FDA-cleared SilverHawk System. The NightHawk device utilizes fiber optic technology embedded in the catheter and allows the physician to visualize the vascular morphology and wall structures. The OCT embedded catheters are designed for use as an adjunct to conventional angiography to provide an image of the vessel lumen and wall structures.

"We believe that if and when approved, the NightHawk will be useful in treating PAD patients, and may someday allow us to eventually expand the use of our products to other areas of the body," said John Simpson, Ph.D., M.D., FoxHollow's founder and Chief Executive Officer.

In October 2006, FoxHollow announced the first in-man use of this new technology with encouraging results. Patients were treated at the American Heart of Poland Hospital in Bielsko by lead investigator Professor Pawel Buszman. The procedures were also attended by a team of U.S. interventional cardiologists, which included FoxHollow founder and CEO, Dr. John Simpson, Dr. Stefan Kiesz and Dr. Greg Robertson. In January 2007, FoxHollow conducted additional evaluations with the NightHawk technology by Professor Horst Sievert at the CardioVascular Center, Frankfurt Germany.

For more information visit www.foxhollowtech.com.

Related Content

News | Drug-Eluting Balloons| August 15, 2017
Surmodics Inc. announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug...
Ra Medical Systems Granted Broad Patent for DABRA Catheter
News | Peripheral Artery Disease (PAD)| August 09, 2017
August 9, 2017 — Ra Medical Systems announced that the United States Patent and Trademark Office (USPTO) has granted
The LimFlow Percutaneous Deep Vein Arterialization System (pDVA) converts veins into arteries to restore blood flow in critical limb ischemia (CLI).

The LimFlow Percutaneous Deep Vein Arterialization System (pDVA) converts veins into arteries to restore blood flow in critical limb ischemia (CLI). This image shows how the covered stents used with the system connect to create a new arterial pathway.

News | Peripheral Artery Disease (PAD)| August 02, 2017
Aug.
Spectranetics Announces FDA Approval of Stellarex Drug-Coated Balloon
Technology | Drug-Eluting Balloons| July 26, 2017
The Spectranetics Corp. announced receipt of U.S. Food and Drug Administration (FDA) pre-market approval (PMA) of the...
First European Patient Enrolled in Intact Vascular's TOBA II BTK Trial
News | Stents Peripheral| July 26, 2017
Intact Vascular Inc. recently announced that its Tack Optimized Balloon Angioplasty II Below the Knee (TOBA II BTK)...
Sponsored Content | Videos | Peripheral Artery Disease (PAD)| July 25, 2017
This video case study, provided by Gore Medical, is titled "Tackling Complex Cases in Dialysis Access," by John Ross,
First Patient Treated in U.S. Feasibility Study of LimFlow Critical Limb Ischemia Device
News | Peripheral Artery Disease (PAD)| July 17, 2017
LimFlow SA announced enrollment of the first patient in the U.S. feasibility study of the LimFlow Percutaneous Deep...
FDA Approves Six-Month Primary Endpoint for Tack Endovascular System in Below the Knee Disease
News | Stents Peripheral| July 14, 2017
Intact Vascular Inc. announced the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption...
Philips Announces Relaunch of Pioneer Plus IVUS-Guided Catheter
News | Chronic Total Occlusion (CTO)| June 28, 2017
June 28, 2017 — Royal Philips recently announced the relaunch of its Pioneer Plus...
Shockwave Medical Announces U.S. Commercial Availability of Lithoplasty System
News | Peripheral Artery Disease (PAD)| June 26, 2017
Shockwave Medical recently announced two milestones for its Lithoplasty System for the treatment of calcified plaque in...
Overlay Init