PROTEX Coronary Stent System
The PROTEX Coronary Stent System combines Nexeon’s RIVIERA coronary stent implant with SurModics’ Finale™ Prohealing Coating. The Finale coating, which incorporates extracellular matrix (ECM) proteins, is designed to improve and accelerate tissue healing of implantable medical devices through the body’s own healing mechanisms. ECM proteins stimulate the specific migration and proliferation of endothelial cells (cells that line blood vessels) to promote healing. The proprietary SurModics PhotoLink® coating process covalently attaches the appropriate ECM proteins to the stent surface. This biomimetic surface can signal endothelial cells in the blood and vascular wall to form a stable endothelial lining over the implant.
This combination of a best-in-class implant with a groundbreaking new coating has the potential to revolutionize the coronary stent market by creating a low-restenosis stent system without the late thrombosis problems that have plagued drug-eluting stents.
Product Attributes
- Ultra-low profile – Inversion Point stent technology allows for a 0.86mm crossing profile.
- Thin strut stent design – The total thickness of the coated stent is just 77µm.
- Prohealing coating – The FINALE coating is designed to accelerate the natural healing process following stenting. The photos below show histology demonstrating 100% cell coverage (left) and functional endothelium via CD-31 antibody staining (right) at two weeks in a preclinical model.
- Short-term antiplatelet therapy – PROTEX will only require 30 days of antiplatelet therapy. This regimen contrasts with the one year minimum recommendation for patients treated with drug eluting stents (DES). Due to the delayed healing of DES an FDA Advisory Panel recommended that all DES patients remain on dual antiplatelet therapy for a minimum of one year.
- Low post-deployment recoil – Inversion Point stent technology reduces the stent recoil seen after deployment. The post-deployment recoil of PROTEX is 30% lower than the market leading coronary cobalt alloy stent.
- Excellent radial strength, vessel coverage and radiopacity – Inversion Point stent technology gives PROTEX frontline characteristics that are equal or greater than today's market leading cobalt alloy stent system.
- Lubricious catheter coating – PROTEX utilizes the Harmony™ advanced hydrophilic coating from SurModics, a lubricious coating designed for unsurpassed deliverability and durability.
CAUTION – Investigational device. Limited by Federal (U.S.) law to investigational use. |