Opto Circuits' Unetixs Vascular bags CE certification for Revo 1100
Unetixs Vascular Inc., a US based group company of Opto Circuits (India) Limited and a leading manufacturer of peripheral vascular devices, has received CE (Conformité Européenne) mark to market and sell its leading product Revo 1100 in Europe. The CE certificate confirms that Revo 1100 met the necessary EU consumer safety, health and environmental requirements.
The Unetixs’ Revo 1100 peripheral vascular diagnostic system and vascular profiler enables vascular technologists to perform non-invasive, simultaneous bilateral ankle (or toe) brachial index (ABI or TBI) tests, to detect peripheral arterial disease (PAD). PAD is a disease in which plaque builds up in the arteries that carry blood to head, organs, and limbs. PAD increases risk of coronary heart disease, heart attack, stroke, and transient ischemic attack (mini-stroke). Early detection and treatment of PAD may slow or stop disease progress.
The system also helps in conducting in-depth ‘vessel specific’ ABI studies for diagnosis or post-intervention follow-up, by obtain individual pressures & waveforms from the dorsalis pedis and posterior tibial arteries, or to detect reduced blood flow with Unetixs’ virtually unbreakable TruDop continuous wave Doppler probes available in 8 MHz and 5 MHz models.
“Unetixs’ Revo 1100 has been very well received in the US market since its launch 4 years ago. CE certification will enable us to market and sell this device in key markets like Europe, Asia, Latin America and other countries with such regulatory requirements. The device will help doctors and medical professionals to conduct highly efficient and accurate PAD test, allowing many undiagnosed patients with poor peripheral circulations and diabetics, to receive early treatment that can reduce the risk of complications”, said Ramnani, CMD Opto Circuits India Ltd.
The system’s dual-channel photoplethysmography (PPG) capability, incorporating easily applied PPG probes and digit clips, enables you to measure ABI and TBI pressures without holding a probe. Its two-channel calibrated pulse-volume recording capability enables you to obtain bilateral waveforms simultaneously. Both PPG and C-PVR tests can be performed within five minutes.
Unetixs’ Revo 1100 is ideal for internists, podiatrists, endocrinologists and primary care single-physician or group practices, mobile services, clinics or as an addition to cardiologists’ or vascular specialists’ offices. Medical professionals can perform a test, review the report, send it to a vascular lab or specialist to review and interpret, and have it returned using Revo Reporter VascuLink or Unetixs DICOM networking and reporting software.