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Product & Clinical overview

Innovating through Technology

The Biosensors International Group (“Biosensors” or “Biosensors “International”) develops, manufactures and markets innovative medical devices, designed to improve patients’ lives through pioneering medical technology, which pushes the boundaries of innovation.

Drug Eluting Stents (DES)

Biosensors International consistently innovates in stent technology. Our (DES) system marketed from 2008 onwards was the first to feature a unique abluminally-coated stent with a biodegradable polymer, absorbed synchronously with their proprietary limus1. Our highly lipophilic BA9™ anti-restenotic drug was specifically developed by Biosensors International for use on coronary stent applications.

An enhanced version was then launched in Asia, Europe, the Middle East and Africa in May 2010, and had the drug and polymer coated on a highly flexible platform designed to enhance deliverability. Our second generation DES entered the market in 2013 with a further enhanced delivery system. The stent is deployed using an advanced delivery system, featuring a low tip entry profile, longer distal shaft and a reduction in shaft diameter for 5F compatibility2.

Our third generation DES was launched in January 2016, utilizing the same biodegradable polymer and proprietary limus agent on a CoCr stent platform. This platform features a hybrid stent design, combining straight and s-shaped link3 connectors, providing enhanced longitudinal strength while maintaining flexibility. This unique design, combining the cobalt chromium alloy with the proven coating of our proprietary biodegradable polymer and Biolimus A9™, gives us a market leading DES.

The DES family allows treatment of simple and complex coronary lesions4,5,6 and offers unparalleled performance in all coronary lesion types. The excellent technical characteristics are complemented by an extensive clinical research program.


Our first generation Drug Coated Stent (DCS)

The world’s first and only polymer and carrier free Drug Coated Stent

Biosensors' latest innovation is our unique Drug Coated Stent (DCS) (combination of our proprietary drug Biolimus A9™ coated without polymer and carrier). It represents the latest development in Biosensors stent technology and differentiates radically from current DES.

It is a polymer and carrier-free DCS that combines the advantages in efficacy of a DES with the safety of a bare metal stent (BMS).

The combination of a selectively micro-structured surface (SMS) and the rapid transfer of Biosensors own highly lipophilic limus agent Biolimus A9™, makes our DCS the most relevant choice of stent for High Bleeding Risk (HBR) patients who cannot tolerate long dual antiplatelet therapy (DAPT).

These DCS’s unique characteristics, allows neointimal proliferation inhibition like any other DES having various polymer without the potential side effects of long term exposure to a polymer7.

Our DCS is now listed as stent of choice in ESC DAPT guidelines, for 1-month ultra-short DAPT in patients whom longer DAPT regimes poses safety concerns8.


ALLEGRA™ Transcatheter Heart Valve - Uncompromised Hemodynamics. By Design

The heart is what keeps us going. It powers the body; it gives us life and energy. So does it fuel our commitment to address valvular heart disease as this can have a major impact on our wellbeing and be life-threatening.

The ALLEGRA™ TAVI System TF has been designed for uncompromised hemodynamic performance with single digit mean pressure gradients and high effective orifice areas.13-14

It is a catheter-based transfemoral heart valve system, indicated for the treatment of severe calcified aortic valve stenosis in high risk patients with elevated surgical risk or in patients with a symptomatic degeneration of an aortic valve bioprosthesis.

ALLEGRA™ has been designed for uncompromised hemodynamic performance with single digit mean pressure gradients and high effective orifice areas13-14. The outstanding hemodynamics of the ALLEGRA™ are particularly important in small native annuli and surgical valves (ViV). Whatever the anatomic situation, coronary access must be maintained. Durability of a transcatheter heart valve is critically important in younger patients.


In Evidence Based Medicine we Trust!

At Biosensors International, we are committed to continuing investment in developing pioneering medical technology and engineering new medical devices, that will further benefit patients. Strongly committed to the values of an Evidence Based Medicine approach, Biosensors was the first company to sponsor a randomized head-to-head comparison against a sirolimus eluting stent in an all-comer setting. The LEADERS trial proved non-inferiority on a clinical endpoint against Cypher® Select in 2008 with primary endpoint analysis published in the Lancet9 and continuous positive long term results up to 5 years10.

Supporting our unique DCS, LEADERS FREE11 is the world’s first prospective, randomized double-blind trial of an active stent, with only 1 month of  DAPT mandated for all patients. The trial was specifically designed for High Bleeding Risk (HBR) patients only and had co-primary endpoints, to confirm that the DCS is as safe as a BMS with superior efficacy. The results were published in the New England Journal of Medicine in October 201511.

Both primary endpoints (safety and efficacy at 1 year) were met with impressive statistical significance and superior safety was achieved. The results were confirmed at 2 years12.


11181-000-EN - Rev.04

1. Ostojic and al - The pharmacokinetics of Biolimus A9 after elution from the BioMatrix II stent in patients with coronary artery disease: The Stealth PK Study; Eur J Clin Pharmacol (2011) 67:389–398
2. SR-10401 - Comparative Performance Study of BioMatrix VI and Competitors’ Products
3. 11582-000-EN – Rev.01
4. Hildick-Smith D et al. EuroPCR 2015
5. Windecker S et al. Lancet. 2008; 372;1163-73
6. Serruys PW, et al. JACC Cardiovasc Interv. 2013; 6:777-89
7. S. WL LEE EuroPCR 2015
8. European Heart Journal (2018) 39, 213–254  
9. Windecker S et al. Lancet 2008; 372: 1163–1173
10. JACC Cardiovasc Interv. 2013 Aug:6(8):777 89
11. Urban P. et al. N Engl J Med. 2015;373(21):2038-47
12. Garot P et al. 2-Year Outcomes of High Bleeding Risk Patients After Polymer-Free Drug-Coated Stents. JACC VOL.6 9, NO.2 , 2017
13. Wenaweser et al, Transcatheter aortic valve implantation with the NVT Allegra transcatheter heart valve system: first-in-human experience with a novel self-expanding transcatheter heart valve, EuroIntervention 2016
14. Schaefer et al, Thirty-d ay outcomes of a novel transcatheter heart valve to treat degenerated surgical valves: the VIVALL multicentre, single-arm, pilot study; EuroIntervention, 2019

 

CAUTION: Please note that the following pages are exclusively reserved for Health Care Professionals in countries with applicable health authority product registrations. To the extent this site contains information intended for use by licensed medical professionals, such materials are not intended to offer professional medical advice. Prior to use, please consult device labeling for prescriptive information and operating instructions. Please contact your Biosensors International representative for availability or the products and registration status.

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 NeoFlex™, BioMatrix™ Alpha, BioFreedom™, BioFreedom™ Ultra, BMX-J® and RISE™ NC, 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 NeoFlex, BioMatrix Alpha, BioFreedom, BioFreedom Ultra, BMX-J, Juno, S-Stent and Rise NC 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.