JERUSALEM, May 2, 2022 /PRNewswire/ -- VOTIS Subdermal Imaging Technologies Ltd. announced today that it has enrolled the first patient in the feasibility study of its PedCheckTM device at Hadassah Medical Center in Jerusalem, Israel.
The pilot study, entitled "The Use of Hemodynamic Occlusive Vascular Response (HOVR™) technology to Screen for Peripheral Arterial Disease (PAD)", is intended to test the feasibility, usability, and safety of VOTIS's proprietary PedCheck™ device. The PedCheck™ is in development and has not yet been approved or cleared for sale.
The PedCheck™ is designed to non-invasively measure PAD at specific locations deep within the patient's foot. It does this by directing light into the foot and measuring its scattering and absorption. In a procedure, a pressure cuff is inflated and deflated around the patient's thigh, while the PedCheck™ directs infrared and near-infrared light into specific locations within the foot. The PedCheck™ is expected to provide the treating physician with useful information about the location and severity of the disease.
PAD can cause foot ischemia, in which blood flow (and thus oxygen) is restricted in the foot. When a person with PAD gets a cut, a nick, or even an abrasion on his or her foot, the wound may not heal, and instead may develop infection or gangrene, requiring amputation. Diabetic foot amputations are associated with increased illness and death. A person with diabetes is 23 times more likely to undergo a lower-extremity amputation than someone who does not have diabetes. People with PAD also commonly have progressive vessel obstructions elsewhere in the vasculature, and experience increased rates of myocardial infarction (heart attack) and stroke.
According to Yechiel Gellman M.D., Orthopedic Surgeon at the Hadassah Medical Center and the Principal Investigator of the study. "There is a need for an efficient and accurate tool for PAD assessment in specific populations, such as the patients with diabetes who visit our diabetic foot unit. This feasibility study addresses a need that my colleagues and I confront daily in our practice."
Mr. Merrill Weber, Co-Founder, CEO, and President of VOTIS, stated, "We are proud to begin our clinical trial at Hadassah Hospital. Hadassah is one of the leading medical centers in the world, known for its use of advanced technology. Hadassah's participation underscores the growing awareness of the importance of early identification and measurement of PAD."
About VOTIS Subdermal Imaging Technologies, Ltd.
VOTIS Subdermal Imaging Technologies, Ltd. is developing a suite of devices to help people with PAD to keep their feet. The PedCheckTM will measure the depth and severity of PAD. The PedFloTM will provide information about changes in blood flow in the foot during a revascularization procedure. Both devices use VOTIS's proprietary HOVRTM technology, which was developed at Columbia University and has been licensed to VOTIS on an exclusive, worldwide basis for all medical imaging purposes. HOVRTM technology is safe, non-invasive, and free of ionizing radiation. More information about the PedCheck™, VOTIS, and HOVR™ technology can be found at https://www.votis.net.
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SOURCE VOTIS Subdermal Imaging Technologies, Ltd.