St. Jude Medical, a healthcare products manufacturer based in Little Canada, Minnesota, announced that it has successfully enrolled its first patient in its Ilumien I clinical trial. The Ilumien clinical trial is designed to study the safety and efficacy of the company’s PressureWire Aeris fractional flow reserve device.
According to a press release by the company, the clinical trial will comprise 500 total patients. The company hopes to show that the PressureWire Aeris is the best way to utilize coherence tomography during a coronary angiography operation. The device uses a series of specialized sensors to determine arterial blood pressure in a patient. By calculating the fractional flow reserve that is associated with stenosis and heart disease, it’s possible to improve patient safety during angiography operations.
Frank Callaghan is the cardiovascular and ablation technologies division president at St. Jude Medical. In prepared remarks, he said, "Our Fame family of trials have demonstrated the compelling value of FFR in the treatment of coronary artery disease, and we are now working with leaders in the field to develop further evidence of OCT use and how it can positively impact physician decision-making." He continued, "We are confident that the Ilumien I study will result in establishing more efficient lab procedures for physicians and better treatment plans for patients."
Fractional flow reserve technology has led to a bitter legal battle between Volcano and St. Jude Medical, both medtech giants. Both companies experienced wins and losses. After winning an initial round this fall, Volcano lost in the most recent lawsuit.