The United States and European headquarters are located in Morges (Switzerland) with manufacturing operations in Singapore. Members of the Biosensors International Group (“Biosensors”) are dedicated to serving the needs of the healthcare community globally, with the combination of a direct sales network and distributors across the world. We are committed to the support of bona fide medical education and advancing the progress of medical science to improve patient care, through training courses, scientific summits and symposia and related events on a regular basis, both in international forums and at national level.
In the USA, Biosensors has an R&D facility in Irvine California focused on the development of innovative interventional cardiology devices.
Biosensors Europe SA does not manufacture or market interventional cardiology products in the United States. These products are commercialized in non US regions with a CE Mark. They are not approved by the United States Food & Drug Administration, and are not available for prescription or use in the United States.
For more than 25 years, Biosensors has been developing and marketing critical care catheter systems and related devices used during heart surgery and intensive care treatment.
In the year 2000, Biosensors entered the interventional cardiology market and immediately became the first cardiology company to develop and patent their own proprietary limus agent, Biolimus A9™ (BA9™), a highly lipophilic1 anti-restenotic drug designed specifically for cardiovascular stent technologies.
> In 2006 we carried out the First-In-Man implantation of the world’s first polymer and carrier free stent coated with Biolimus™
> In 2008 Biosensors presented the results of the LEADERS2 (Limus Eluted From A Durable Versus ERodable Stent Coating) randomized, noninferiority trial, the first all-comers trial of PCI.
> In 2010, we presented the results of the First-In-Man study of the world’s first polymer and carrier free stent coated with Biolimus A9™
> In 2013 we presented the results of COMFORTABLE AMI3, the first trial of a DES to show an efficacy and safety benefit vs BMS in patients with AMI.
> In 2015 we presented the results of the LEADERS FREE4 trial, the first trial to exclusively enroll High Bleeding Risk* patients and randomize them to an active stent with just one month of ultra-short DAPT
> In 2018 at TCT in San Diego, the result of GLOBAL LEADERS5,6 was presented, the largest all-comer trial of PCI. At the same meeting, we presented the results of LEADERS FREE II, the first trial to enroll a High Bleeding Risk US patient population to an active stent and just one month of DAPT
Over the last two-decades Biosensors has become one of the largest manufacturers and suppliers of cardiovascular stents globally.
* All-comer as per definition of Inclusion criteria of LEAERS FREE: Age >75, Oral anticoagulants, Cancer, Surgery soon, poor DAPTcompliance anticipated post PCI, Renal failure, Anemia,Thrombocytopenia, Previous stroke, Liver failure, Admission for bleeding, NSAID / Steroids, Prior intra cerebral bleed
1. Data on file Biosensors International Group Ltd – Report RD–00020 - Validation / Verification of ElogPoct Determination Method and Measurement of ElogPoct for Zotarolimus
2. Serruys P. Improved safety and reduction in stent thrombosis associated with biodegradable polymer-based biolimus-eluting stents versus durable polymer-based sirolimus-eluting stents in patients with coronary artery disease: final 5-year report of the LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) randomized, noninferiority trial. JACC Cardiovasc Interv. 2013 Aug;6(8):777-89
3. Raber et al. Effect of Biolimus-Eluting Stents With Biodegradable Polymer vs Bare-Metal Stents on Cardiovascular Events Among Patients With Acute Myocardial Infarction The COMFORTABLE AMI Randomized Trial JAMA. 2012;308(8):777-787
4. Urban p. et al. Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk N Engl J Med. 2015;373(21):2038-47
5. Vranckx P. et al. Ticagrelor plus aspirin for 1 month, followed by ticagrelor monotherapy for 23 months vs aspirin plus clopidogrel or ticagrelor for 12 months, followed by aspirin monotherapy for 12 months after implantation of a drug-eluting stent: a multicentre, open-label, randomised superiority trial. The Lancet, Vol. 392, No. 10151, p940–949.
6. GLOBAL LEADERS is a study sponsored by ECRI, supported by a financial grant from Biosensors International Group, Ltd. and other companies.