Biosensors International Group, Ltd. products

At least 20% of PCI patients are High Bleeding Risk (HBR) where there is a need to avoid prolonged dual antiplatelet therapy (DAPT).1-9 .The BioFreedomTM Drug-Coated Stent (DCS) is significantly safer and significantly more efficacious than a BMS in High Bleeding Risk patients, with a DAPT regime of only one month, the shortest DAPT regime mandated for all patients in a published, double-blind randomized controlled trial.10. By directly delivering BA9TM - an effective anti-restenotic therapy - without polymer or carrier, becoming a BMS at 28 days, the DAPT regime can be shortened when treating patients with the BioFreedom stent.10

Only the abluminal surface of the stent receives SMS treatment, allowing BA9™ to be contained within the micro-structured surface and delivered with high specificity to the vessel wall of the coronary lesions. The SMS process allows for an increased surface area for a uniform dose of BA9 to be delivered to the target lesion. With no need for polymer or carrier, BA9 and SMS make BioFreedom a true Drug-Coated Stent (DCS).

BA9, an effective Cytostatic Limus Drug: Rapid 28 day BA9 transfer to the vessel wall achieved through enhanced high lipophilicity delivering: Greater Local Bioavailability. Targeted Drug Release. Local tissue warehousing allowing Sustained Tissue Release, with Therapeutic Effect up to 100 days12,13. Longer Half Life than other commonly used Limus Drugs, approximately 20 days in tissue12,13. Potent Neointimal Suppression.

Low Late Loss: 9 month in stent late loss 0.13mm6. In Stent late loss in LEADERS = 0.13mm6.

Designed for below the knee interventions: BioPath 014 is a drug-eluting balloon dilatation catheter designed for percutaneous transluminal angioplasty (PTA) and has been optimized for the treatment of patients with peripheral arterial disease. BioPath 014 is intended for infrapopliteal interventions below the knee. This paclitaxel-eluting balloon feature a proprietary shellac coating technology which consistently delivers paclitaxel, an anti-restenotic drug during very brief inflation times, while also minimizing washout of the drug during delivery and placement of the drug-eluting balloon. BioPath 014 balloon catheter offer excellent pushability, trackability and crossability due to a low balloon profile, low tip entry profile and hydrophilic coating on the distal shaft of the catheter.