The Paladin System is designed to reduce the risk of stroke by providing extra protection during the carotid stenting procedure. Paladin has received FDA 510(k) clearance for sale in the United States.

Paladin®

Carotid PTA Balloon System with Integrated Embolic Protection

Despite the widespread use of embolic protection devices, the risk of stroke remains one of the biggest challenges in carotid artery stenting. The Paladin Carotid PTA Balloon System with Integrated Embolic Protection contains an angioplasty balloon and an integrated 40 μm filter, coupled together for the first time. Whether the operator chooses to use a distal filter or a proximal occlusion as a primary method of embolic protection, the additional protection provided by the Paladin filter can provide an added measure of protection and efficiency in carotid stent procedures.

Indications For Use: The Paladin System with Integrated Embolic Protection (IEP), is indicated for Percutaneous Transluminal Angioplasty (PTA) in the carotid arteries with capture and removal of embolic material. This device is also indicated for post-dilation of 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.

Caution: Federal (United States) law restricts this device to sale by or on the order of a physician. Prior to use, refer to Instructions for Use provided in product packaging.

Easy Single-Step Deployment & Removal

 

Stroke Protection
When it Matters Most

Ischemic stroke risk remains unacceptably high in carotid stent procedures, even with the use of conventional embolic protection devices. Some groups such as symptomatic patients and octogenarians are at higher risk than others.¹

Size Matters
Paladin Captures What Others Miss2

  • The Paladin filter captures smaller emboli. Paladin pore sizes are ≈ 40 μm while commercially available filters are generally greater than 100 μm.
  • Better wall apposition (capture efficiency) by being able to adjust the filter diameter to suit the patient’s anatomy.
“The Paladin System offers optimized micro-embolic protection during the most vulnerable aspects of the procedure, without additional device transitions or procedural time.”
Dr. William Gray

References

  1. Carotid Artery Stenting in Octogenarians. Periprocedural Stroke Risk Predictor Analysis From the Multicenter Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare Events (CAPTURE 2) Clinical Trial Stroke. 2010; 41: 757-764 doi: 10.1161/STROKEAHA.109.569426; Stroke. 2007; 38: 707-714 doi: 10.1161/01.STR.0000250047.01624.fd
  2. Data on File at Contego Medical.

Paladin is 510(k) cleared in the U.S. Caution: Federal (United States) law restricts this device to sale by or on the order of a physician.