History: Established in 2003, OpSens’ technology was originally used in oil and gas, some industrial applications, and by some medical device manufacturers to measure temperature, pressure, and displacement. Their success in these industries well established their reputation as an expert in measurements using sensor technology. However, the team recognized a greater potential for such uniquely effective systems and their ability to do more at a larger and more medically impactful scale, by focusing on cardiology applications. In 2009, OpSens Medical expanded the business strategy into the global fractional flow reserve (FFR) market. Directly shifting their focus to providing resolutions to cardiologists’ needs for more sophisticated measurement, document, and evaluation instruments for their work and their patients.
Our team had built a relationship with the OpSens team from the inception and although hesitant of the initial indications, we saw the potential to benefit patients and continued to monitor the expansion. Following the logical turn to bring pressure guidewires to market for cardiac care and recognizing the exceptional progress made to achieve this, our support in 2016 was undeniable. Our investment in OpSens Medical was a distinctive opportunity to reinvent the course of care for coronary disease and bring best-in-class solutions that offer better outcomes to healthcare systems and patient lives. Coronary artery disease is the most common type of heart disease and a leading cause of death in North America. OpSens versatile technology continues to outperform the standards of care and provide greater resolutions to many critical clinical limitations. As the company continues to make exceptional progress, we are thrilled to be a part of bringing forward the new gold standard of interventional cardiology care.
Solution: The OptoWire™, OPTOMONITOR™ AND SAVVYWIRE™
The OptoWire™ is an advanced pressure guidewire powered by Fidela, a 2nd generation fiber optic sensor. Allowing physicians to more precisely measure the Fractional Flow Reserve (FFR) and diastolic Pressure Ratio (dPR), to determine the severity of coronary artery blockage. The design and performance mimic a workhorse guidewire. With a small structure and distinct engineering properties, the resistance, flexibility, and sensitivity is enhanced. Physicians are able to use a single device and obtain multiple measurements across complex structures with high confidence in the accuracy of results. The wire durability also allows it to perform stenting and b
alloon angioplasty without the need to replace the wire and lose accuracy. With disconnect and reconnect capabilities, physicians can easily measure and adapt to different anatomies, perform appropriate interventions, and confirm improvements following stent implantation.
The SavvyWire™ is the first and only 3-in-1 sensor-guided solution for Transcatheter Aortic-Valve Replacement (TAVR) procedures. Engineered to enhance TAVR efficiency while improving lifetime patient management. The device supports stable aortic valve delivery and positioning with continuous hemodynamic measurements during the procedure, and reliable ventricular pacing without the need for adjunct devices or venous access.
The OptoMonitor™ system, a paired smart integration tool, enables convenient measurement management directly at the tableside or integrated into monitoring systems. Physicians can immediately measure pressure in the artery after blockage and compare it instantaneously with measurements prior. Generating faster, more actionable diagnoses and decisions, allowing patients to go home without suffering from symptoms.
Generating Impact: In various clinical studies, pressure guidewires have proven substantial impacts on patients and clinical practice:
Today, the Optowire is the gold standard of care, having been used in the diagnosis and treatment of
This rapid adoption has led to the installation of more than 2,000 OptoMonitor units in clinics, and growing use by clinical partners to improve their success rates in challenging coronary interventions. The Optowire is currently approved for sale in the United States, European Union, Japan, and Canada, with channels for sales globally.
OpSens’ demonstrated patient impact does not stop here. The company now intends to capitalize on its expertise in coronary artery disease to extend its activities to structural cardiology, with the SavvyWire. With a global TAVR market of over 200,000 procedures and an expectation to reach 400,000 in 2027, the SavvyWire is on a path for enormous and expansive patient impact. To date, the SavvyWire has been cleared by Health Canada and U.S. FDA and completed procedures in the U.S, Europe, while most recently extending pacific coast presence in New Zealand.