September 17, 2018
FDA Clears Contego's Paladin Carotid PTA Balloon System With Integrated Embolic Protection
September 18, 2018—Contego Medical, LLC announced that the FDA has granted 510(k) clearance for its Paladin carotid percutaneous transluminal angioplasty (PTA) balloon system, which is a filter-based integrated embolic protection (IEP) device.
According to Contego Medical, the Paladin system is indicated for PTA in the carotid arteries for capture and removal of embolic material. The device is also indicated to postdilate self-expanding stents in the carotid arteries with capture and removal of embolic material. The diameter of the arterial site for filter deployment should be no more than 7.0 mm. The Paladin system with IEP should always be used in conjunction with an available embolic protection device.
The company noted that the Paladin system couples an angioplasty balloon and integrated 40-µm filter. The microembolic protection of the Paladin filter is designed for maximum capture efficiency and provides an added measure of protection and procedural flexibility in carotid stenting procedures. The system allows the physician to adjust the size of the embolic protection filter in vivo to suit each individual patient's anatomy.
The Paladin system has received CE Mark approval. The company announced the European launch of the device in January 2016. Contego announced the completion of enrollment in a European postmarket registry.
The system has been studied in 106 registry patients undergoing carotid artery stenting with a variety of stents, including open-cell, closed-cell, and mesh-covered designs, with no procedural strokes and a 30-day risk of death, stroke, and myocardial infarction of 0.9%, stated Contego Medical.
William Gray, MD, commented in the company's announcement, "Minor stroke continues to be the Achilles heel of carotid artery stenting, which occurs as a result of microembolization during the procedure. The Paladin system offers optimized microembolic protection during the most vulnerable aspects of the procedure, without additional device transitions or procedural time." Dr. Gray is System Chief of the Division of Cardiovascular Disease at Main Line Health in Wynnewood, Pennsylvania.