News & Events

Home / News & Events

BVI étend son site de lentilles intraoculaires avec une nouvelle installation ultramoderne en Belgique.

WALTHAM, Massachusetts – 18 juill. 2023 (GLOBE NEWSWIRE) — BVI, l’une des entreprises de chirurgie ophtalmique à la croissance la plus rapide au monde, est fière d’annoncer l’ouverture de sa nouvelle installation ultramoderne à Liège, en Belgique. Celle-ci permettra d’augmenter considérablement sa capacité de production de lentilles intraoculaires (LIO), ouvrant de nouvelles opportunités de croissance et renforçant le leadership environnemental, social et de gouvernance (ESG) de l’entreprise

Fidèle à son engagement en matière d’efficacité, de durabilité et de conformité, la nouvelle installation de BVI est conçue pour optimiser la production. Elle implique un examen complet des processus visant à optimiser le rendement et l’efficacité. BVI accorde sa priorité aux considérations environnementales et met en œuvre diverses mesures pour minimiser son empreinte carbone.

Affirmant son engagement pour l’innovation, cette installation accroit ses capacités de recherche et développement (R&D) et de fabrication. En mettant l’accent sur la production de produits innovants et de qualité destinés aux patients, ce nouveau site de production favorise la collaboration, le développement et la production des LIO, ainsi que le lancement de nos produits sur de nouveaux marchés.

Cet investissement stratégique illustre l’engagement de BVI envers la croissance économique, le progrès technologique et son dévouement au maintien du leadership de l’industrie. Alors que BVI se lance dans cette aventure passionnante, la société anticipes des retombées économiques positives importantes.

Frédéric Jodogne, responsable des opérations, a déclaré : « Je vois dans cette installation ultramoderne un signe de stabilité. BVI confirme que Liège est un pilier clé dans la recherche, le développement et la production de LIO. Des produits, des salariés et un potentiel incroyables! Chaque employé peut être fier du parcours déjà accompli et voir clairement le chemin vers un avenir prospère.

Shervin Korangy, Président Directeur Général de BVI, a également déclaré : « Je félicite notre équipe qui a dirigé cet important projet d’expansion. Leur engagement inébranlable envers l’excellence a joué un rôle déterminant dans notre objectif de tripler notre capacité de production de lentilles intraoculaires tout en déployant des optiques moulées de haute précision selon les normes de qualité les plus élevées. La combinaison de nos designs optiques brevetés et de notre technologie de fabrication de classe mondiale crée un résultat élégant et inégalé. Notre expertise en LIO a constamment dépassé mes attentes les plus élevées. »

À propos de BVI

BVI® est une société globale et diversifiée de dispositifs ophtalmiques dont la mission est de fournir des solutions et des innovations de haute qualité pour faire progresser la chirurgie oculaire et améliorer la vision des patients. Avec neuf décennies de développement de produits et de solutions de pointe, BVI s’associe à des chirurgiens ophtalmologues pour améliorer la vision de millions de patients à travers le monde. Notre organisation soutient des équipes chirurgicales dans plus de 90 pays à travers le monde, directement, ou via notre réseau de distributeurs de confiance. Nos marques de confiance incluent Beaver® (couteaux et lames), Visitec® (canules), Malosa® (instruments à usage unique), Vitreq® (produits chirurgicaux vitréo-rétiniens) et PhysIOL® (LIO haut de gamme).

Pour plus d’informations ou pour contacter un représentant de BVI, veuillez envoyer un e-mail à Andrew Dawson, Responsable de la Communications d’Entreprise de BVI : adawson@bvimedical.com

BVI launches FINEVISION HP, a novel hydrophobic trifocal IOL based on the FINE optical technology platform, in Japan.

  • FINEVISION HP is the first patented diffractive trifocal IOL and is one of the flagship products in BVI’s IOL portfolio; FINE Trifocal technology is utilized across the company’s entire range of presbyopia-correcting IOLs.
  • The Japan launch follows two key FINEVISION HP 2023 milestones: One million FINEVISION IOL implants sold worldwide and the recent completion of the FINEVISION HP IDE clinical study patient enrollment in the US.
  • BVI expects to introduce several IOL models over the next few years in Japan, demonstrating BVI’s commitment to ophthalmic surgeons and their patients in Japan.

WALTHAM, Mass.,June 19th, 2023 (GLOBE NEWSWIRE) BVI, one of the fastest growing surgical ophthalmic businesses in the world, is thrilled to announce the official launch of FINEVISION HP in Japan. The FINEVISION HP hydrophobic and glistening free trifocal IOL represents a significant breakthrough in trifocal technology as the first trifocal platform to offer cataract patients high quality vision across all distances. 

Given substantial excitement and interest in the product, BVI Japan has already received orders for FINEVISION HP and will host the official launch event at the upcoming Japanese Society of Cataract and Refractive Surgeons (JSCRS) annual meeting in Sapporo, Japan on June 22 through June 24.  Dr. Kazunori Miyata (Miyata Eye Hospital), Dr. Hisaharu Suzuki (Zengyo Suzuki Eye Clinic), and Dr. Yousai Mori (Miyata Eye Hospital) will be presenting the results of the clinical trial conducted in Japan.  

As part of BVI’s commitment to continuously improve product performance to meet patients’ and surgeons’ needs, the FINEVISION HP IOL is now in its third generation since the initial FINE optical technology platform was launched in 2010. BVI has developed this unique IOL with numerous novel designs, including proprietary, patented hydrophobic material, a one-of-a-kind double C loop haptic design, and patented CoPODize™ optical surface technologies which enables Convolution and Apodization across the entire optic zone.  As the trifocal market leader in Europe, BVI has proven this technology with over 10 years of success and one million FINEVISION implants sold across the world.    

Dr. Kazuo Ichikawa of Chukyo Eye Clinic, Nagoya said: “It is great to see a new option of Multifocal IOL lens for our patients in Japan. Not only was FINEVISION the original trifocal, but the new generation FINEVISION HP provides 20/20 vision from -3D to +.5D of defocus as well as controlling dysphotopsia.

Shervin Korangy, BVI President and CEO said: ‘‘I could not be more pleased with the feedback we are receiving from surgeons about their experience partnering with BVI. The FINEVISION launch in Japan continues to execute on our strategic vision of expanding into key markets globally. Our commitment to bring BVI’s world-class products to surgeons and patients across the world is unwavering and continues at an accelerated pace. I look forward to watching our team’s success with this and subsequent product launches in the Japanese market”.

About BVI

BVI® is a diversified global ophthalmic device company with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients. With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe. Our organization supports surgical teams in more than 90 countries worldwide, either directly or through our network of trusted distributors. Our trusted brands include Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs).

For further enquiries or to speak to a BVI representative, please email Andrew Dawson, Head of BVI Corporate Communications: adawson@bvimedical.com

BVI Announces Complete Enrollment of FINEVISION® HP IDE Clinical Study

WALTHAM, MA – May 1, 2023 (GLOBE NEWSWIRE) — BVI, a diversified global ophthalmic device company, today announced it has completed enrollment of its U.S. Investigational Device Exemption (IDE) clinical study for its latest hydrophobic trifocal intraocular lens, FINEVISION® HP. 

The milestone marks the final implantation of the 539th patient enrolled in the prospective, multicenter, randomized, masked, controlled IDE clinical study.  Patients will now be followed to evaluate the safety and performance of the FINEVISION HP intraocular lens, with the results to form the basis for a regulatory submission to obtain marketing approval in the United States.

BVI has one of the most comprehensive ophthalmic surgery portfolios in the industry and is committed to expanding its availability globally.

“With the IDE clinical study completing both the enrollment and implantation phase in less than 12 months, we are pleased with our momentum and acknowledge the patients and clinical investigators for their commitment to the trial,” said Devang Shah, Ph.D., BVI Senior Vice President, Business Operations.

Shervin Korangy, BVI President and CEO, added, “Achieving this milestone represents an exciting and significant step towards bringing our IOL technology to US patients and surgeons.  This trial is the first of a series of studies on innovative ophthalmic devices that BVI will be undertaking in the U.S. in the coming years.”

FINEVISION® HP is a hydrophobic trifocal IOL and the third generation in the FINEVISION® family, featuring BVI’s proprietary hydrophobic material and two novel patented CoPODize™ technologies enabling Convolution and Apodization concepts on the entire optic surface.

CAUTION  FINEVISION® is CE Marked since 2010.  FINEVISION® HP is an Investigational device in the United States. Limited by Federal Law to investigational use; Pending PMA, not available for sale within the United States. 

About BVI

BVI® is a diversified global ophthalmic device company with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients. With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe. BVI supports surgical teams in more than 90 countries worldwide, either directly or through its network of trusted distributors. BVI trusted brands include: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs).

Contacts

BVI

Andrew Dawson

Corporate Communications

adawson@bvimedical.com

Investors

Vivian Cervantes

Gilmartin Group

IR@bvimedical.com

BVI Announces Certification for its Intraocular Lens Portfolio under the European Medical Device Regulation

WALTHAM, Mass., Sept. 15, 2022 (GLOBE NEWSWIRE) — BVI, a diversified global ophthalmic device company, today announced certification for its intraocular lens (IOL) portfolio under the European Medical Device Regulation (MDR, (EU) 2017/745) from its Notified Body, the British Standards Institution (BSI)¹. The new regulatory criteria came into effect in May 2021, replacing the prior Medical Device Directive (MDD).

The MDR, representing the most significant change to European regulatory framework in decades, ensures a consistently high level of health and safety for medical devices. The new provisions focus on:

  • Strict requirements with the intention to prove the safety of medical devices for both users and patients;
  • Increased transparency of clinical evaluation, post market surveillance, and clinical investigation that needs to be up to date, clear, convincing, and publicly available;
  • Greater emphasis on detailed requirements for technical documentation;
  • Increased control and monitoring by national competent authorities and the EC;
  • Reclassification of devices, wider scope of devices; and
  • New Unique Device Identification system with enhanced traceability and post-market surveillance.

“Achieving and maintaining MDR certification is a major effort that requires a tremendous amount of investment, capabilities, and hard work,” said Shervin Korangy, BVI President and CEO. “This important milestone ensures continued supply of our innovative and clinically differentiated IOLS to our surgeons and patients worldwide.”

BVI Senior Vice President, Business Operations and Quality Assurance, Devang Shah, Ph.D. added, “We are proud to have obtained this certification, in partnership with our Notified Body BSI, which confirms BVI’s commitment to quality and compliance to the highest of regulatory standards. A recent MedTech report highlighted that Notified Bodies have yet to issue MDR certificates for more than 85% of the products certified under the prior directives² – so being at the forefront of this is a testament to our team’s expertise and dedication to our customers.”

About BVI

BVI® is a diversified global ophthalmic device company with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients. With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe. Our organization supports surgical teams in more than 90 countries worldwide, either directly or through our network of trusted distributors. Our trusted brands include: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs).

  1. BSI Client Directory Profile: https://www.bsigroup.com/en-GB/validate-bsi-issued-certificates/client-directory-profile/PHYSIO-0047610705-000
  2. https://www.medtechdive.com/news/legacy-devices-lack-mdr-certificates-medtech-europe/627439/
Website available

FLORetina

Meet the BVI team at ROME CAVALIERI, A WALDORF ASTORIA HOTEL CONGRESS CENTER

Website available

CBO

Meet the BVI team in Curitiba, Brasil.

Website available

ASRS

Meet the BVI team in New York city.

Website available

DOC

Meet the BVI team at Nürnberg Convention Center in Nürnberg.

Website available

GIVRE

Meet the BVI team at the Rimini Conference Center (Palacongressi di Rimini – IEG Expo).

Website available

BRASCRS

Meet the BVI team in Salvador.

Website available

Euretina

RAI Amsterdam, Pays-Bas

Website available

ESCRS

Messe Wien Exhibition Congress Center, Vienne, Autriche

Website available

AOO