Medistim received clearance from the China Food and Drug Administration (CFDA) for sale of MiraQ™ Systems.
MiraQ™ represents Medistim’s most advanced system for ultrasonic surgical guidance and quality assessment used intraoperatively during coronary artery bypass grafting (CABG) as well as vascular and transplant surgery. The system combines state-of-the-art transit time blood flow measurement (TTFM) with a high frequency ultrasound imaging modality. By adding ultrasound imaging to blood flow measurements, it will become easier for the surgeon to plan, optimize and assess the quality of the surgical procedure. MiraQ™ is a unique tool that can contribute to improved surgical precision and quality, which may ultimately provide better outcomes for the patients.
Medistim has already launched MiraQ in the USA, Europe and other markets accepting the CE certificate, and is now positioned to sell the product in all its major markets except Japan, where an application is in process.
Globally, about 700 000 coronary artery bypass graft (CABG) procedures and 600 000 vascular procedures are being performed every year. China represents a significant market opportunity for Medistim with about 50,000 CABG procedures performed per year and a projected annual growth rate of 5 to 10 %. Today, Medistim covers >30 % of these procedures with its traditional flow measurement system VeriQ. “Medistim is well positioned for further growth in China, with a number of systems placed with the largest cardiac centers and supported by leading Chinese surgeons”, says Kari E. Krogstad, President and CEO in Medistim ASA and continues: “Finally, we can offer our premium product to the Chinese market. There is already a growing interest for the combination of ultrasound imaging and TTFM measurements amongst surgeons in China, and the future outlook is good.”