Sensimed receives FDA product approval for its Contact Lens with AnSem ASIC.
Sensimed received the marketing clearance of its first-of-kind product, the SENSIMED Triggerfish®, by the U.S. Food and Drug Administration (FDA).
The SENSIMED Triggerfish® is a unique sensor-embedded contact lens based system that Sensimed developed with the aim to improve the management of glaucoma. AnSem, Europe's leading ASIC design and Turnkey solutions provider designed the fully integrated sensor and telemetry system on an ASIC and is providing the ASIC in volume production to Sensimed.
The Triggerfish® provides a wireless automated recording of continuous ocular dimensional changes over the course of 24 hours. This first-of-a-kind measurement parameter whilst, closely correlated with intra-ocular pressure (IOP) is a unique measure in itself. A recent study* published in Ophthalmology linked this unique continuous volumetric eye measurement to glaucoma disease progression and concluded that the SENSIMED Triggerfish® "may be useful in detecting eyes at higher risk of glaucoma progression while receiving treatment".
The FDA reviewed the SENSIMED Triggerfish® application through the De Novo Process used for first-of-a-kind technologies that are not substantially equivalent to an already marketed device. The SENSIMED Triggerfish® was classified in the newly created category entitled Diurnal Pattern Recorder System, defined as:
A diurnal pattern recorder system is a non-implantable, prescription device incorporating a telemetric sensor to detect changes in ocular dimension for monitoring diurnal patterns of intraocular pressure (IOP) fluctuations.
The device has been approved with the following indication:
The SENSIMED Triggerfish® is a prescription device indicated to detect the peak patterns of variation in intraocular pressure over a maximum period of 24 hours to identify the window of time to measure intraocular pressure by conventional clinical methods. The SENSIMED Triggerfish® is indicated for patients 22 years of age and older.
William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health commented in their official release: "The Triggerfish gives the clinician 24-hour continuous monitoring of changes in IOP patterns that otherwise could not be obtained". He added: "This information can help determine the most critical time of day for the clinician to measure the patient's IOP."
"We are delighted to have worked closely with FDA on this De Novo application and to have gained approval for this first-of-a-kind contact lens-based sensing device in the USA", said David Bailey, the CEO of Sensimed. "There is a very strong interest within the ophthalmic community for the whole concept of contact-lens based sensing and we are extremely proud to have created and developed the first ever product approved in this category."
* Visual Field Change and 24-Hour IOP-Related Profile with a Contact Lens Sensor in Treated Glaucoma Patients, De Moraes C. G. et al. - Ophthalmology, in Press
AnSem is Europe's leading fabless analog ASIC design service company, designing and delivering state-of-the-art analog, RF and mixed-signal integrated circuits to customers worldwide. Founded in 1998 and based in Leuven, Belgium, AnSem specializes in the development of advanced integrated circuits for wired and wireless data transmission, sensor data acquisition, ultra-low power and high voltage applications. AnSem is ISO 9001 certified and is a proven and solid development partner for ambitious and visionary customers, reaching for leadership in global markets.
To find out more, please visit the AnSem website at www.ansem.com
FROM DEVICE TO KNOWLEDGE -- Sensimed AG, a Swiss company, has developed a unique non-invasive soft contact lens-based solution, the SENSIMED Triggerfish®, with the aim of revolutionizing glaucoma management by providing an automated recording of continuous ocular dimensional change over 24 hours. The Company is currently expanding the knowledge of how this individual data can best be used in the clinical setting to deliver customized treatment. The 24 hour profiles are being centralized on a registry together with patient and treatment information.
The data are analyzed and modeled on an ongoing basis in an attempt to identifying pathological patterns that can be used to differentiate between indications, personalize treatment and assess efficacy following treatment. The Company is directly positioned at the convergence between devices, treatment and information. Sensimed believes that with this global knowledge based approach we will be able to provide valuable insights that will allow ophthalmologists to better understand and treat glaucoma.
For further information about Sensimed see: www.sensimed.ch
Phone: +32 16 38 65 00