Launches New Ozaki Procedure Instrumentation (single-use) in the USA

We are honored to announce that we have launched a new single-use sizer set（The OZAKI AVNeo™ Sizer System[1]) for aortic valve reconstruction[2] in the USA.

The new single-use sizer set design has been improved in both user-friendliness and safety. JOMDD, Inc. has developed this new single-use sizer set for quick, easy and safe usage in the OR.  Registration with the U.S. Food and Drug Administration (FDA) has been completed.

Features of the New OZAKI AVNeo Sizer System:

1.Sizer Redesign

The new single-use sizer set is much smaller, as compared to previous sizer sets, which prevents the damaging of a narrow annulus. The new sizer set is available in three sizes; Standard (21/23/25/27/29), Pediatric (13/15/19) and Large (31/33/35).

2. Template for Reproducibility Precision

The template, which provides for 12 cusp sizes, enables both precise trimming of the cusps and guiding of suturing and commissure reinforcement.

3. Enhanced User-friendliness in the Operating Room

The new single-use sizer set is compact and includes all necessary tools, such as a tray and plate for pericardium treatment and a tri-compartmental petri dish to maintain the treated, trimmed cusps before use. The new sizer set will reduce staff workload and improve safety.

This product has been launched in the USA in January 2017. JOMDD, Inc. is the manufacturer and distribution is provided by a local representative. Please contact avneo_admin@jomdd.com for further information.

Please note that all company, product and technique names used in this press release are registered and unregistered trademarks of JOMDD, Inc..

JOMDD, Inc. commercializes Japanese healthcare innovation using our experience, skill and knowledge. We aim to achieve our vision of “Healthcare Innovation from Japan to the World” and to contribute to improve healthcare quality and revitalize the healthcare industry.

[1] Aortic Valve Neo-cuspidization

[2] Aortic valve reconstruction surgery

Aortic valve reconstruction is an advanced technique that Professor Shigeyuki Ozaki has devised at the Cardiovascular Surgery Department of Toho University, Ohashi Medical Center, Tokyo, Japan. Unlike the conventional valve replacement of implanting a prosthetic valve, this procedure uses the patient’s own pericardium. According to Professor Ozaki, “It does not require anti-coagulant therapy (such as warfarin) for post mechanical valve replacement surgery and compared with biological valves, it has the potential to achieve excellent long-term results owing to the low-impact physiological movement of the base of the valve (valve annulus).”