11.21.14
Implandata Ophthalmic Products GmbH (Implandata) reports the first successful implantation of its intraocular pressure-measuring micro sensor in Kiel, Germany. The patient who received the sensor is part of the company's ARGOS-02 clinical study, which is being conducted at six eye centers in Germany.
Study organizers currently are recruiting primary open angle glaucoma patients undergoing cataract extraction. These patients are eligible to receive the implantable micro sensor for wireless intraocular pressure measurement.
During cataract surgery Implandata’s intraocular pressure sensor is placed in front of the artificial intraocular lens, posterior to the iris. After implantation of the micro sensor the patient’s intraocular pressure measurements can be measured at any chosen frequency, either continuously over the course of 24 hours or on demand at certain times. Patients can perform measurements by themselves and under normal live conditions. Collected data will be sent via a mobile phone module to the eye doctor’s computer screen, allowing him to remotely monitor and manage the patient’s disease.
“So far the first results of this innovative product are very compelling“, concludes Prof. med. Detlef Uthoff, M.D., medical director of Augenklinik Bellevue in Kiel. “Up to date, early diagnosis and therapeutic management of the disease have been rather dissatisfying for eye doctors. But this [product] allows us for the first time to personalize and control therapy according to the specific needs of the glaucoma patient.”
Implandata’s intraocular pressure sensor allows close monitoring of the patients disease status and glaucoma therapy success. Through simple and more frequent measurements of intraocular pressure - which is the key parameter in glaucoma therapy - important information on therapy response is delivered to the eye doctor early on, enabling immediate glaucoma therapy adjustment, contributing to prevention of further vision loss due to uncontrolled intraocular pressure.
In the ongoing ARGOS-02 study Implandata will generate sufficient data to approach the CE conformity process for intraocular placement of the micro sensor in 2015. Currently the product is not CE marked or approved by the U.S. Food and Drug Administration. But Implandata is planning to conduct in foreseeable future additional clinical studies in Europe and the United States to validate various product versions for various glaucoma patient situations.
Implandata Ophthalmic Products GmbH is a privately held medical device company founded in 2010 and headquartered in Hanover, Germany.
Study organizers currently are recruiting primary open angle glaucoma patients undergoing cataract extraction. These patients are eligible to receive the implantable micro sensor for wireless intraocular pressure measurement.
During cataract surgery Implandata’s intraocular pressure sensor is placed in front of the artificial intraocular lens, posterior to the iris. After implantation of the micro sensor the patient’s intraocular pressure measurements can be measured at any chosen frequency, either continuously over the course of 24 hours or on demand at certain times. Patients can perform measurements by themselves and under normal live conditions. Collected data will be sent via a mobile phone module to the eye doctor’s computer screen, allowing him to remotely monitor and manage the patient’s disease.
“So far the first results of this innovative product are very compelling“, concludes Prof. med. Detlef Uthoff, M.D., medical director of Augenklinik Bellevue in Kiel. “Up to date, early diagnosis and therapeutic management of the disease have been rather dissatisfying for eye doctors. But this [product] allows us for the first time to personalize and control therapy according to the specific needs of the glaucoma patient.”
Implandata’s intraocular pressure sensor allows close monitoring of the patients disease status and glaucoma therapy success. Through simple and more frequent measurements of intraocular pressure - which is the key parameter in glaucoma therapy - important information on therapy response is delivered to the eye doctor early on, enabling immediate glaucoma therapy adjustment, contributing to prevention of further vision loss due to uncontrolled intraocular pressure.
In the ongoing ARGOS-02 study Implandata will generate sufficient data to approach the CE conformity process for intraocular placement of the micro sensor in 2015. Currently the product is not CE marked or approved by the U.S. Food and Drug Administration. But Implandata is planning to conduct in foreseeable future additional clinical studies in Europe and the United States to validate various product versions for various glaucoma patient situations.
Implandata Ophthalmic Products GmbH is a privately held medical device company founded in 2010 and headquartered in Hanover, Germany.