US-based medical device company Contego Medical has completed enrolling patients in its study of the Paladin Carotid Post-Dilation Balloon System in Europe to offer an interventional treatment of carotid stenosis.
The Paladin System provides enhanced outcomes by minimising the risk of embolisation during post-dilation, when the patient is most vulnerable to embolic events which can lead to a stroke.
It features an angioplasty balloon and an integrated 40μm filter which are fused together.
It involves a single step procedure which connects the post-dilation balloon at close contact and a small-particle embolic protection filter at the distal catheter tip.
The Paladin balloon is composed of a durable nylon-compliant material and features a low-profile design to ensure high-deliverability.
The Paladin filter is an adjustable in-vivo filter measuring a length of 7mm. It can be deployed in a single, easy step and requires no delivery or recovery sheaths.
Saint Getrauden Hospital, Berlin, Germany angiology director Dr Ralf Langhoff said: "This is a very important study in demonstrating the importance of small particle embolisation capture for carotid stenting.
"Procedural success rate has been high and interim results of 30-day MRI scans are very promising.
“I am pleased to be part of this registry and the study of a new technology that can reduce embolisation and stroke incidence for these procedures to almost zero without adding any sophisticated and time-consuming procedural steps.
“The technology is already embedded into our standard-of-care procedure technique for carotid artery stenting."
The new device is based on integrated embolic protection (IEP) technology and features an intuitive and versatile system which is expected to assist the physicians to safely treat carotid stenosis.
Image: CT image displaying right internal carotid artery blockage. Photo: courtesy of James Heilman, MD.