TORONTO--(BUSINESS WIRE)--ConaviTM Medical Inc. is pleased to announce that Japan Lifeline has submitted an application for the regulatory approval of the Novasight HybridTM intravascular imaging system in Japan. In addition, Japan Lifeline will serve as the exclusive distributor of the Novasight Hybrid intravascular imaging system in Japan. Novasight Hybrid is the world’s first system to have been used clinically that is capable of providing both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) on a single imaging catheter. Earlier this year, the Novasight Hybrid system received FDA 510(k) clearance in the United States and was featured by Conavi Medical at the TCT 2018 Interventional Cardiology conference.
Dr. Brian Courtney, Conavi Medical’s Chief Executive Officer, comments that "The announcement of Japan Lifeline applying for regulatory approval is an important commercial event for the company. Intravascular imaging is used frequently in the 260,000 angioplasty and stenting procedures performed every year in Japan. The Novasight Hybrid system is uniquely able to simultaneously acquire inherently co-registered IVUS and OCT images. I have been fortunate to work with a number of cardiologists in Japan whose experience and knowledge of intravascular imaging is incredibly profound. The input that we have received from Japanese physicians in the development of our product has been incredibly valuable in ensuring that our technology fits well with their clinical needs.”
"In PCI (Percutaneous Coronary Intervention) in Japan, imaging catheters are used in more than 90% of all cases. The Novasight Hybrid system is the world’s first and unique device as a single disposable catheter combined with both IVUS and OCT functions, enabling physicians to observe the same lesions simultaneously in the coronary artery. In Japan, only one of either IVUS or OCT is covered by reimbursement for one procedure, so we believe that Novasight Hybrid system will perform to the best of the needs in clinical settings in the near future" said Keisuke Suzuki, President and Chief Executive Officer of Japan Lifeline. "We are very keen to expand our intervention business more than ever. In March this year, we launched drug eluting stents. With the Novasight Hybrid system newly added to our product portfolio, we expect to accelerate sales of the existing products too."
About Conavi Medical:
Conavi Medical Inc., is a privately-held Canadian company focused on designing, manufacturing, and selling imaging technologies to guide minimally invasive cardiovascular procedures. For more information, visit http://www.conavi.com/.
About Japan Lifeline Co., Ltd.
Japan Lifeline (JLL) is a manufacturer, importer and distributor of quality medical products. Japan Lifeline is a publicly traded company, ticker symbol TYO:7575. Visit the JLL website at: http://www.japanlifeline.com.