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In Evidence Based Medicine We Trust!

At Biosensors International, innovation and clinical evidence is our driving force. We don’t just bring innovative and unique coronary stents to the market, we conduct robust landmark clinical trials to provide physicians with the confidence they need when choosing a Biosensors stent for their patient’s revascularization procedure.

The Biosensors clinical program is optimized to assess the safety and efficacy of our products through innovative and challenging clinical trials. We work in partnership with the medical community and the world’s leading clinical investigators, to prove our products are safe and efficacious, allowing physicians who implant them to trust in Evidence Based Medicine.
 

BioFreedom™ DCS

LEADERS FREE1 was the first clinical trial to evaluate a one-month ultra-short course of DAPT in High Bleeding Risk (HBR) patients with mixed comorbidities. Superior safety and efficacy over the previous gold standard treatment was demonstrated. The pre-specified LEADERS FREE subgroups add to the wealth of clinical evidence, the LEADERS FREE pre-specified ACS subgroup2 showed a reduction in cardiac death for the patients treated with BioFreedom vs the control BMS.

In 2018, LEADERS FREE II was the first clinical trial with results on a one-month ultra-short course of DAPT post PCI in HBR patients in the USA.
 

BioMatrix™ Family of DES

LEADERS3 was published in the Lancet in 2008. This was the first clinical trial to evaluate a genuine all comer patient population. The study demonstrated that a stent eluting biolimus from a biodegradable polymer represents a safe and effective alternative to a stent eluting sirolimus from a durable polymer in patients with chronic stable coronary artery disease or acute coronary syndromes. The results were confirmed up to 5-years, with a trend towards a reduction in stent thrombosis4. The first continued, TCT 2012 5-year follow-up of LEADERS presented the longest follow-up of an all comers trial to date. The LEADERS AMI subgroup5 demonstrated for the first time a reduction in cardiac death vs SES in STEMI patients.

11882-000-EN - Rev.02 + 11881-000-EN - Rev.04
  1. Urban P. et al. N Engl J Med. 2015;373(21):2038-47
  2. Naber et al. European Heart Journal. 2016; doi:10.1093/eurheartj/ehw203
  3. Windecker S et al. Lancet 2008; 372: 1163–1173.
  4. Serruys P et al. JACC: Cardiovascular Interventions 2013; 6: 777-789
  5. Zang Y-J. et al. Heart 2015;101:271-278

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The law restricts these devices to sale by or on the order of a physician. Prior to use, it is important to read the "Instructions for Use" supplied with these devices for indications, contraindications, suggested procedures, warnings, and precautions.

Biosensors’ interventional cardiology products, including BioMatrix™ Alpha, BioFreedom™, BioFreedom™ Ultra, BMX-J®, RISE™ NC and RISE™ SC, are not available for sale in the United States and certain other countries. ALLEGRA™ is a product of NVT GmbH. Blue Sail Medical Co., Ltd is the ultimate parent company of NVT GmbH and Biosensors International Group, Ltd. and its subsidiaries are collaborating for the commercialization of the ALLEGRA™ device.

BioMatrix Alpha, BioFreedom, BioFreedom Ultra, BMX-J, Juno, S-Stent, Rise NC and Rise SC are trademarks or registered trademarks of Biosensors International Group, Ltd. ALLEGRA is a trademark or registered trademark of NVT AG. All other cited trademarks are the property of their respective owners.