JOMDD Launches New Ozaki Procedure Instrumentation (single-use) in the USA
We are proud to announce the launch of a new single-use sizer set（The OZAKI AVNeo™ Sizer System[1]) for aortic valve reconstruction[2] in the USA.
The new design of the single-use sizer set improves both user-friendliness and safety. JOMDD, Inc. has developed this new single-use sizer set for smoother and safer procedures 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 is much smaller, compared to previous sizer sets, preventing damage to 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 Reproducible Precision
The template, provides for 12 cusp sizes, enabling both precise trimming of the cusps, and guidance of suturing and commissure reinforcement.
3. Enhanced User-friendliness in the Operating Room
The new single-use sizer set is compact and includes all the 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 in each country by local representatives, listed here sales partners.
Note all company, product and technique names used in this press release are registered and unregistered trademarks of JOMDD, Inc..
About JOMDD, Inc.
Japanese Organization for Medical Device Development, Inc., “JOMDD” is a medical device incubator and innovator. Founded in 2012, and based in Tokyo, Japan, JOMDD takes Japanese born medical technologies and commercializes them for global launch. Through its expertise in planning, R&D, regulatory affairs, marketing and sales, JOMDD is able to go from concept to sales rapidly. JOMDD partners with doctors, established manufacturers and start-ups to propel medical innovations. For further information on JOMDD, visit /company_en/.
[1] Aortic Valve Neo-cuspidization
[2] Aortic valve reconstruction surgery
Aortic valve reconstruction or “AVRec” is an advanced surgical technique devised by Professor Shigeyuki Ozaki at the Cardiovascular Surgery Department of Toho University, Ohashi Medical Center, Tokyo, Japan. Unlike the conventional method 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).”
Ordering information
Please contact our sales partners.
CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.