#Greece #CE Mark #EYE PCR #fixOflex #Heraklion

EYE PCR Achieves CE Mark for fixOflex Endocapsular Device

EYE PCR has reached a significant milestone with the receipt of the CE Mark for its fixOflex endocapsular device, a key achievement that opens doors for European market access. This certification complies with the stringent European Union Medical Device Regulation (EU MDR 2017/745), validating the product's safety and effectiveness for both patients and healthcare professionals.

A Major Leap in Ophthalmology

Developed over 15 years under the leadership of Professor Ioannis Pallikaris, fixOflex is designed to maintain the integrity of the capsular sac and its intra-capsular space during cataract surgeries. This innovative approach aims to enhance optical performance, addressing one of the persistent challenges faced in cataract procedures: preserving the capsular shape post-lens extraction. Professor Pallikaris, the founder of EYE PCR, expressed his commitment to overcoming this significant barrier in cataract surgery. He stated, "fixOflex has been crafted to not only maintain the capsular structure but also to optimize the visual outcomes desired by surgeons for their patients."

Receiving the CE mark is a catalyst for EYE PCR, allowing the company to implement its strategy for global expansion. Professor Pallikaris elaborated on future plans, saying, "We expect to invest substantially in providing worldwide access to the fixOflex technology and will keep stakeholders informed as our production and distribution plans are finalized."

Clinical Validation of FixOflex

Clinical trials have been pivotal in demonstrating the reliability of fixOflex. A prospective study involving 121 patients highlighted that the device exhibited comparable safety levels to standard cataract surgery, with a remarkably low incidence of posterior capsule opacification (PCO) at 0.83% after a 12-month follow-up. In contrast, a retrospective control group showed PCO rates at 13.0%. Notably, no patients using the fixOflex device required Nd:YAG laser capsulotomy, while three patients from the control cohort did.

Understanding Posterior Capsule Opacification (PCO)

PCO remains one of the most frequent complications following cataract surgery. Reports indicate that the incidence of PCO is at least 11.8% within one year post-operation. PCO impacts visual acuity and typically necessitates Nd:YAG laser capsulotomy to restore clear vision. Approximately 10% of patients may require this procedure within a year after cataract surgery. The fixOflex device is purposefully built to act as a barrier against the migration of epithelial cells from the lens, thereby minimizing the risk of PCO.

EYE PCR's Commitment to Innovation

Founded by Professor Ioannis Pallikaris, EYE PCR focuses on innovative solutions based on scientific research to tackle complex issues in ophthalmology. The company leverages decades of pioneering research in cataract and refractive surgery, aiming to elevate patient care and outcomes in ophthalmic procedures. EYE PCR is headquartered in Amsterdam, Netherlands, with research and clinical operations primarily based in Heraklion, Greece.

For more information about EYE PCR and the fixOflex device, visit eyepcr.com or follow them on LinkedIn for updates on their innovative technologies and future plans.

Contact Information for Media Inquiries

• - Fenia Pervolaraki: [email protected]
• - Aristofanis Pallikaris: [email protected]
• - Memet Yazici: [email protected]

EYE PCR continues its mission of bringing advancements to a field that directly impacts the quality of life for millions of patients around the world.