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Implandata received FDA Breakthrough Device Designation for its Eyemate-SC in April and now has CE Mark approval in the European Union.
An implantable glaucoma biosensor has received CE mark approval for marketing in the European Union weeks after getting a nod from the FDA.
The sensor (Eyemate-SC, Implandata Ophthalmic Products) is used in conjunction with the company’s Eyemate system for digitally enabled remote glaucoma monitoring and management.
The company states that the patented system is among the first clinically-validated product used for comprehensive remote glaucoma monitoring. US FDA Breakthrough Device Designation (BDD) was obtained in April.
BDD is only assigned for breakthrough technologies that have the potential to provide more effective treatment of life-threatening or irreversibly debilitating diseases in order to provide patients and physicians more timely access to such technologies without compromising safety.
According to Max G. Ostermeier, CEO and founder of Implandata,moving forward under the FDA BDD program means the company will benefit from additional FDA input during the premarket development as well during the submission process and through an expedited review once the submission is filed.
“With FDA market authorization, the Eyemate system will now be entitled to Medicare Coverage of Innovative Technology for at least 4 years, offering beneficiaries predictable access to the breakthrough Eyemate system, helping to improve their health outcomes,” he said.
According to the company, the system is an improved version of its predecessor product. Measuring IOP throughout the day, every day, could allow patients and their physicians to tailor glaucoma medications to the patients’ specific needs, Implandata said.
Ostermeier also noted that obtaining CE mark for the less invasive sensor as part of the company’s validated Eyemate system is another important step forward for the company to transform glaucoma care.
“This new version is expanding the addressable glaucoma patient segment and is more readily and safely implanted than the earlier device,” he said in a statement. “With CE mark, we will start to launch the product with various eye centers across Europe.”
The device empowers patients to self-measure their intraocular pressure, and then automatically sends gathered information in real-time to their eye doctor or to cloud-based storage. This information enables eye doctors to obtain close information about therapy effectiveness and to adjust treatment based on a patient’s current condition rather than make therapeutic adjustments based on only a single measurement of IOP acquired during an office visit.
Robert N. Weinreb, MD, chairman and Distinguished Professor of Ophthalmology at University of California, San Diego and Implandata medical advisor, points out that millions of individuals worldwide are at risk of permanent loss of their vision due to glaucoma.
“With the EYEMATE, intraocular pressure now can be monitored more closely to personalize treatment and avoid further vision loss,” he said in a statement.
Kaweh Mansouri, MD, MPH, is a consultant ophthalmologist at Clinique de Montchoisi Lausanne/Switzerland, and adjoint professor at the Department of Ophthalmology, University of Colorado, Denver. He was one of the lead investigators in the clinical study validating the biosensor.
“With CE Mark of the Eyemate-SC biosensor we can now start to introduce the Eyemate system into our clinical routine, which we have eagerly waited for,” he said in a statement. “Our team has been very pleased with the safety and the performance of the product in our clinical study and is very happy by how well the product is accepted by our patients.”
Moreover, Mansouri pointed out that Eyemate will help ophthalmologists to make more informed therapeutic decisions faster.
“This technology empowers patients, resulting in improved adherence with therapy and less worries about undetected IOP peaks and glaucoma progression,” he concluded.