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Biomatrix™ Alpha

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THE INNOVATIVE HYBRID COBALT-CHROMIUM ABLUMINAL BIODEGRADABLE POLYMER DES

BioMatrix™ Alpha presents the best in class stent platform design with unique pro-healing coating from the pioneer in abluminal biodegradable technology3.

It combines the proven safety of a DES with an abluminal biodegradable polymer, the proven efficacy of BA9™ and an innovative
cobalt-chromium stent platform design.

Abluminal coating absorbed after 6 to 9 months4
No drug carrier or drug inside the stent

  • Early BMS-like endothelial coverage2
  • More targeted drug release
  • Reduced systemic exposure

BA9™ DESIGNED SPECIFICALLY FOR CORONARY STENT APPLICATION

  • Unique drug and proprietary of Biosensors International Group, Ltd.
  • Designed for properties that would support healing and re-endothelialization
  • Chemical characteristics allow:
  •  
  • – delivered with synchronous absorption of proprietary PLA polymer
  • – with no loss to the systemic system.

ALPHA BY DESIGN BEST IN CLASS PERFORMANCE VS OTHER STENTS2

BIOMATRIX™ FAMILY CLINICAL PROGRAM

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Proven safety of the Biolimus A9™ (BA9™) drug

BA9™ DESIGNED SPECIFICALLY FOR CORONARY STENT APPLICATION

Bridging science and innovative technology

In the early 2000’s the available mTOR inhibitor limus drugs, available for coronary stenting, were developed for systemic application. Biosensors developed its own
proprietary limus technology by focusing during the early stages of drug development on its use for vascular technologies

BA9™ Designed for Vascular Stent Technologies, optimized for local drug delivery

The Research and Development team developed several versions of Biolimus, through a number of iterations ultimately decided to focus on BA9™ (Biolimus A9™), as the best
option for coronary stent application. Consequently, Biosensors’ proprietary limus drug BA9™ was used within its BioMatrix™ DES family and BioFreedom™ DCS.

BA9™ Designed for Vascular Stent Technologies, optimized for local drug delivery

> Slower metabolism of drug due to its structure
> High local bioavailability2
> Long 20-day in tissue half-life2
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REFERENCES
1.  Data on file Biosensors International Group, Ltd. – Report RD – 00020 – Validation/Verification of ElogPoct Determination Method and Measurement of ElogPoct for Zotarolimus
2.  Polymer-Free Biolimus A9–Coated Stent Demonstrates More Sustained Intimal Inhibition, Improved Healing, and Reduced Inflammation Compared With a Polymer-Coated Sirolimus-Eluting
Cypher Stent in a Porcine Model. Tada N Circ Cardiovasc Interv. 2010;3:174-183

BIOMATRIX™ FAMILY CLINICAL PROGRAM

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Proven safety of a DES
with an abluminal biodegradable polymer

INNOVATIVE TECHNOLOGY FOR OPTIMIZED ARTERIAL HEALING

The BioMatrix™ family favourably influences local wound healing processes.
Highly localised delivery of anti-restenotic BA9™ for at least six months.
Degradation of specifically designed PLA polymer to lactate, which has the potential to facilitate wound healing.

SPECIFICALLY DESIGNED PRO-HEALING POLYMER
NOT ALL POLYMERS ARE THE SAME

  • Biosensors’ PLA polymer degrades to naturally occuring Lactic Acid and Lactate
  • Lactate plays a key role in local arterial wound healing processes, mainly via enhanced Vascular Endothelial Growth Factor (VEGF) production6,7

The localized presence of PLA-derived lactate has the potential to facilitate arterial wound healing, including re-endothelialization6-7

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REFERENCES
6. Gladden LB. J Physiol. 2004;558(1):5-30
7. Ghani, QP. et al. Methods in Enzymology. 2004;381(36):565-75

BIOMATRIX™ FAMILY CLINICAL PROGRAM

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Stent platform

UNCOMPROMISED PERFORMANCE

From Design to Implant – What you see is what you get!
The BA9™ stents on a cobalt chromium platform are designed for optimal adaptability and apposition to respect the vessel anatomy.
From Promise to Reality
This is no longer just a promise, but a double effect reality!… BA9™ stents great apposition increases also the drug distribution performance to improve healing4,7
All the OCT images used in the brochure are courtesy of Dr Frankie Tam, Hong Kong

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REFERENCES
4. Ishihara T, et al. Comparison of 1-Month and 12-Month Vessel Responses Between the Polymer-Free Biolimus A9-Coated Stent and the Durable Polymer Everolimus-Eluting Stent. Circ J. 2022 Jun 4. doi:10.1253/circj.CJ-22-0098;
7. Hansen KN, et al. Early vascular healing after implantation of the polymer-free biolimus-eluting stent or the ultrathin strut biodegradable polymer sirolimus-eluting stent in patients with ST-segment elevation myocardial infarction. Coron Artery Dis. 2022 May 1;33(3):196-205. doi: 10.1097/MCA.0000000000001113;

BIOMATRIX™ FAMILY CLINICAL PROGRAM

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THE BIOMATRIX ALPHA REGISTRY1 FIRST CLINICAL EVIDENCE CHARACTERIZING SAFETY AND EFFICACY OF THE NEW COCR BIOLIMUS-A9 ELUTING STENT

Single arm, prospective, multi-center registry, 400 patients from 12 sites in 4 countries.
All patients received BioMatrix Alpha™ stents as per clinical practice and were  followed for 2 years for data collection.
Primary Endpoint Major adverse cardiac events (MACE) composite of cardiac death, myocardial infarction (Q-wave and non-Q-wave),or clinically driven target vessel revascularization (TVR) at 9 months.
 

Results at 9 months

> MACE 3.78% – Cardiac Death: 0.75% – MI: 1% – Def/Prob ST: 0.25%
 

Results at 24 months

> MACE 6.65% – Cardiac Death: 1.29% – MI: 2.82% – Def/Prob ST: 1.12%

LEADERS2 THE FIRST ALL COMERS TRIAL OF PCI
(LIMUS ELUTED FROM A DURABLE VERSUS ERODABLE STENT COATING)

1:1 randomized control trial to prove non-inferiority to the current gold standard stent BioMatrix Flex™ vs Cypher® Select™
1700 patients from 10 European centers. Patients suitable for PCI enrolled, with limited exclusion criteria
Primary endpoint was non-inferiority of MACE (Cardiac death, MI, cd-TVR) at nine months
Planned follow-up of 5 years – subgroups.
 

Results:

> MACE non-inferior at 9 months
> 0.66% ST from 1-5 years
> Significant reduction in Patient Oriented Composite Endpoint (All-cause Death, Any MI, All Revascularization) at 3,4 & 5 year follow-up
 

Clinical benefit shown in patients undergoing complex PCI2

> 5 year MACE significantly reduced BES vs SES in high Syntax score ≥12 patients
> BioMatrix™ achieved a significant reduction in Stent Thrombosis in high Syntax score ≥12 patients
> Significant reduction in MACE driven by a reduction in Cardiac Death in STEMI subgroup at 1 year
> In CTO patients 30 days post implant BioMatrix demonstrated a significant reduction in MACE, ci-TVR and Stent Thrombosis
> Significant reduction in Cardiac death in AMI STEMI patients at 5 years

E-BIOMATRIX3

Excellent and impressive long term data for BioMatrix™ Family in more than 5’000 real-world patients.
> 5,000 all comer patient registry
 

Results 3 years4:

> MACE 9%
> Cardiac Death 2.1%
> ci-TVR 5.6%
> MI 3.2%

COMFORTABLE AMI 2 YEAR FOLLOW-UP5

A randomized trial 1:1 BioMatrix Flex vs Gazelle BMS
To evaluate the BioMatrix Flex in an AMI population vs the current BMS gold standard.
Primary endpoint MACE (Cardiac Death, TV-MI, cd-TLR): 52% reduction in MACE vs the BMS
> 64% reduction in ci_TLR
> 3% reduction in TV-MI
> 1.4% ST at 2 years
> A safety and efficacy benefit maintained out to 5 years

Thus, BioMatrix has become the Gold Standard in biodegradable technology.

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REFERENCES
1. Clinical Outcomes with Cobalt Chromium Biolimus DES compared with Stainless Steel Biolimus DES in All-Comers Patients after 2 years. Presentation I. Menown TCT CONNECT 2020.
2. 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. Serruys P. et al JACC Cardiovasc Interv. 2013 Aug;6(8):777-89
3. Outcomes Following Implantation of the Biolimus A9-Eluting BioMatrix Coronary Stent: Primary Analysis of the e-BioMatrix Registry. Urban P. et al. Cathet. Cardiovasc. Intervent 86:1151–1160 20154. Final 3-year Report of the e-BioMatrix Registry, David Hildick-Smith, 2015
5. Five-year clinical outcomes and intracoronary imaging findings of the COMFORTABLE AMI trial: randomized comparison of biodegradable polymer-based biolimus-eluting stents with bare-metal stents in patients with acute ST-segment elevation myocardial infarction. Raber et al.  Eur Heart J. 2019 Jun 21;40(24):1909-1919.

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.