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

EYE PCR's Recent Milestone in Cataract Surgery Innovation

On February 13, 2026, EYE PCR made a significant leap in the field of ophthalmology by obtaining CE Mark certification for its innovative fixOflex endocapsular device. This certification, which aligns with the European Union's Medical Device Regulation (EU MDR 2017/745), paves the way for the commercialization of fixOflex within Europe and other territories that recognize the CE mark.

The journey to this achievement was spearheaded by Professor Ioannis Pallikaris, who has dedicated over fifteen years to the research and development of this groundbreaking technology. The fixOflex device is specifically engineered to maintain the structural integrity of the capsular bag during and after cataract surgery, significantly enhancing the optical outcomes that surgeons aim to achieve. According to Professor Pallikaris, the team's persistent focus on overcoming the challenges surrounding capsular preservation has culminated in a product that optimizes visual performance.

Clinical Evidence Supports Device Effectiveness

Supporting the efficacy and safety of fixOflex, a rigorous prospective study was conducted with 121 patients who underwent cataract surgery using the device. The results were telling: the incidence rate of Posterior Capsule Opacification (PCO), one of the common complications post-surgery, was a mere 0.83% within the first twelve months for patients using fixOflex. In stark contrast, a control group demonstrated a PCO incidence rate of 13.0%. Furthermore, none of the fixOflex patients required Nd:YAG laser capsulotomy, which is often necessary to restore clear vision in patients affected by PCO. This data not only emphasizes the device's innovative design but also its potential to revolutionize patient outcomes in cataract surgery.

Understanding Posterior Capsule Opacification (PCO)

PCO remains a prevalent complication following cataract surgeries, with research indicating that approximately 11.8% of patients may experience it within a year. This condition can significantly impair visual acuity and frequently necessitates corrective procedures such as Nd:YAG laser capsulotomy to regain clarity of vision. FixOflex's distinctive design aims to create a barrier that prevents the migration of lens epithelial cells, which is crucial for minimizing the risk of PCO.

The Path Forward for EYE PCR

With the CE marking now secured, EYE PCR is poised for a controlled market introduction of the fixOflex device, coupled with plans to broaden its global footprint. Professor Pallikaris expressed enthusiasm towards enhancing the availability of fixOflex technology worldwide, outlining the company's commitment to advancing eye care through sustained global expansion strategies.

Founded by Professor Pallikaris, EYE PCR has always focused on addressing significant challenges in ophthalmology using evidence-based scientific innovation. The firm is headquartered in Amsterdam, with vital research and clinical operations taking place in Heraklion, Greece. As EYE PCR prepares for the next steps in production and distribution, it is eager to share further updates that will highlight their continued progress in providing effective solutions to critical ophthalmological issues.

For more insights into EYE PCR's groundbreaking developments, visit eyepcr.com or connect with them on LinkedIn.