BVI to Launch New SERENITY and SERENITY Toric Premium Monofocal IOLs

Posted on | by fletanter

BVI to Launch New SERENITY and SERENITY Toric Premium Monofocal IOLs, Delivering an Extended Range of Vision to More Patients, at the 2024 ESCRS

  •  Non-diffractive IOLs SERENITY and SERENITY Toric are the second generation of BVI’s original, innovative ISOPURE premium monofocal IOL launched in 2019.
  • These IOLs incorporate patented ISOFOCAL optic technology to provide both distance vision and intermediate vision.1 The ground-breaking double c-loop POD platform is specifically engineered to deliver precise astigmatism correction and stable IOL positioning.2
  • These lenses are designed to meet the growing demand for intermediate-optimized IOLs, which are projected to see a 15% CAGR. 3

Waltham, MA, September 3, 2024 – BVI today unveiled its latest innovations: SERENITY and SERENITY Toric premium monofocal IOLs. These non-diffractive, aspheric IOLs are the second generation of BVI’s pioneering ISOPURE family, first introduced in 2019. Utilizing patented ISOFOCAL optic technology to elegantly balance Depth of Focus (DoF) and image quality, these lenses provide far vision equal to a monofocal but with good intermediate vision up to 66 cm.1

Continuing the IOL Innovation Legacy

Since the launch of ISOPURE in 2019, BVI has remained committed to providing innovative solutions for patients seeking an uncompromised, extended range of vision. The SERENITY series maintains the simplicity of a monofocal IOL while incorporating ISOFOCAL technology to deliver spherical aberration correction across the entire optic diameter and customize the level of spherical aberration per dioptric power.

The SERENITY Toric model benefits significantly from the maneuverability of the double C-loop POD platform. This platform is exclusive to BVI and allows the IOL to be rotated clockwise or counterclockwise to align the cylinder with the axis. For astigmatic patients, the POD platform delivers a toric IOL that remains stable in the capsular bag,2 with outcomes accurately predicted by BVI’s toric calculator.

Mr. Sheraz DayaMD FACP FACS FRCS(Ed) FRCOphth (Centre For Sight, UK), one of the first surgeons to implant SERENITY, commented, “It is wonderful to see this Increased range of focus lens (IROF) on the same platform as the Finevision with 4 C loop haptics. I look forward to the Toric version as well which I know will be very stable with no rotation.”

“As we launch the second-generation SERENITY and SERENITY Toric IOLs, BVI views this IOL as potentially a game-changer when it comes to standard of care for monofocal procedures,” saidShervin Korangy, President and CEO of BVI. “Our portfolio includes a wide range of IOLs, meticulously designed from material to haptics to optics to provide the optimal outcome without the burden of retro-fitting legacy predicate devices.”

Global Launch Schedule

SERENITY and SERENITY Toric will have full commercial availability in CE-accepting markets in 20254.

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.

For further enquiries or to speak to a BVI representative, please email Andrew Dawson, Head of BVI Corporate Communications: [email protected]

References

1.      Bernabeu-Arias G, Beckers S, RincónRosales JL, Tañá-Rivero P, Bilbao-Calabuig R. Visual Performance at Different Distances After Implantation of an Isofocal Optic Design Intraocular Lens. J Refract Surg. 2023 Mar;39(3):150-157.

2.      Robert Edward T Ang, Pedro Tañá-Rivero, Francisco Pastor-Pascual, Pavel Stodulka, Manfred Tetz, Isaak Fischinger. Visual and Refractive Outcomes After Bilateral Implantation of a Biconvex Aspheric Toric Monofocal Intraocular with a Double C-Loop Haptic Design. Clinical Ophthalmology 2023:17 2765–2776.

3.      P 188 Marketscope 2024

4.      Not Available for Sale in the United States

BVI lance la LIO monofocale hydrophobe PODEYE au Japon.

Posted on | by Marine Leruth

Deuxième entrée de BVI sur le marché en moins de douze mois

  • BVI continue d’exécuter sa feuille de route de lancements de LIO au Japon, le troisième marché mondial en termes de valeur pour les LIO1
  • Le monofocal hydrophobe PODEYE est parfaitement adapté au marché japonais, où les LIO hydrophobes constituent près de 96 % du total des unités de LIO monofocales au Japon1
  • Suite au lancement en 2023 de la LIO hydrophobe trifocale FINEVISION HP, PODEYE devient la deuxième LIO BVI à être disponible au Japon

WALTHAM, Mass., 18 avril 2024 (GLOBE NEWSWIRE) BVI, la société la plus dynamique et diversifiée en ophtalmologie, a annoncé aujourd’hui le lancement officiel de la LIO monofocale hydrophobe PODEYE au Japon après l’approbation de l’Agence japonaise des produits pharmaceutiques et des dispositifs médicaux (PMDA). . Cette réalisation représente une autre étape importante dans le plan de BVI visant à lancer sa gamme de LIO au Japon à court terme.

Dévoilé lors de la réunion annuelle de la Société Japonaise d’Ophtalmologie (JOS) à Tokyo, PODEYE est désormais disponible pour un usage commercial et accessible aux chirurgiens de tout le pays.

« Notre engagement sur le marché ophtalmologique japonais est une priorité évidente pour BVI. Le lancement de PODEYE continue de mettre en œuvre notre vision stratégique et notre expansion mondiale. Nous sommes prêts à fournir aux chirurgiens davantage de solutions pour améliorer les soins aux patients. Attendez-vous à des lancements de produits plus révolutionnaires de notre part au Japon et sur de nombreux autres marchés majeurs dans le monde. a déclaré Shervin Korangy, président et chef de la direction de BVI.

La stabilité rendue simple.
En mettant l’accent sur la stabilité de la LIO, la conception haptique à double boucle en C, désormais éprouvée, connue sous le nom de « POD », unique aux lentilles BVI, a été introduite pour la première fois sur le marché avec le lancement de la LIO hydrophobe PODEYE en Europe en 2012. BVI a démontré le succès de sa technologie POD avec plus de 10 ans de ventes réalisées dans le monde entier. Réputée pour sa conception haptique nouvelle et unique en son genre (double boucle en C), garantissant un centrage fiable de la LIO et une stabilité en rotation, la plateforme POD a gagné en popularité et sert de base à toutes les futures LIO BVI.

Focus sur la sécurité
Étant donné que le Japon est avant tout un marché hydrophobe, les chirurgiens japonais, comme leurs homologues du monde entier, apprécieront le matériau exclusif et hydrophobe « GFY® » à partir duquel les BVI IOLS sont fabriqués, fournissant un matériau 100 % sans brillant.

De plus, la société a également démontré une expertise à l’échelle du marché dans le développement de matériaux pour LIO. Parallèlement à son matériau GFY breveté, présent exclusivement dans les lentilles BVI, BVI développe et fournit également environ 20 % de matériaux pour LIO aux sociétés concurrentes de LIO dans le monde entier depuis son usine de Floride, aux États-Unis.

À propos de BVI

BVI® est une société mondiale 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 ophtalmologistes 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, soit directement, soit 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 vitréorétiniens) et PhysIOL® (LIO premium).

Pour plus d’informations ou pour parler à un représentant des BVI, veuillez envoyer un e-mail à Andrew Dawson, responsable des communications d’entreprise des BVI : [email protected]

1 Données “Market Scope”

BVI Expands IOL Capacity with New State of the Art Facility in Belgium

Posted on | by Marine Leruth

WALTHAM, Mass. — July 18th, 2023 (GLOBE NEWSWIRE) — BVI, one of the fastest growing surgical ophthalmic businesses in the world, is proud to announce the opening of its new, state of the art facility in Liège, Belgium.  This results in a sizeable increase in BVI’s intraocular lens (IOL) business capacity, unlocking new growth opportunities and reinforcing the company’s environmental, social, and governance (ESG) leadership.

In line with the company’s commitment to efficiency, sustainability, and compliance, the new facility was designed to optimize delivery and involved a comprehensive process review aimed at increasing yield and efficiency.  BVI also prioritized environmental considerations and implemented various measures to minimize carbon footprint.

Affirming BVI’s commitment to innovation, the facility further enlarged BVI’s integrated IOL research and development (R&D) and manufacturing capabilities.  With a clear focus on delivering pioneering, quality products to patients, the integrated R&D and manufacturing installation promotes seamless collaboration, efficient product development and production, and accelerated time to market.

This strategic investment exemplifies BVI’s commitment to economic growth, technological advancement, and dedication to maintaining industry leadership. As BVI embarks on this exciting journey, the company anticipates significant positive contributions to its financial success and overall economic landscape.

Frederic Jodogne, Head of Operations said: “I see in this newly built state of the art facility a sign of trust in BVI that confirms Liège as a key pillar in IOL R&D and production.  Amazing products, amazing staff, and amazing potential! Each employee can be proud of the journey already accomplished and can see clearly now the path toward a successful future.”

Shervin Korangy, BVI President and CEO said: “I commend our team who drove this significant capital expansion project. Their unwavering commitment to excellence has been instrumental in tripling our IOL production capacity whilst in parallel deploying cutting-edge, proprietary precision molded optics to the highest quality standards.  The combination of our patented, novel optical designs alongside our world-class manufacturing technology creates an elegant and unrivaled outcome. Our IOL expertise has consistently surpassed even my lofty expectations.”

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: [email protected]

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

Posted on | by gds

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/