NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced today that the first surgeries were performed in Japan using the Precept® posterior fixation system.
On July 31, 2013, NuVasive received regulatory Shonin approval for Precept products, opening the door for the Company to offer a minimally disruptive posterior fixation solution to patients and surgeons in Japan. The approval furthers the Company's ability to participate in the world's second largest spine market, where the eXtreme Lateral Interbody Fusion (XLIF®) approach and other posterior products were previously approved. The Precept Posterior Fixation System provides surgeons with unprecedented ability to treat a wide range of pathologies, all while offering an unparalleled ease of use.
Surgeon proctors, who will instruct upcoming Precept training courses, have started to schedule surgeries now that the new system is available.
"We have our sights set on changing spine surgery and improving patient outcomes in Japan, an exciting new market for us," said Alex Lukianov, NuVasive Chairman and Chief Executive Officer. "With the approval and launch of Precept, we can introduce Japanese surgeons to additional innovation within our comprehensive portfolio of procedurally integrated spine solutions."
Russell Powers, NuVasive Executive Vice President of International, said, "We are absolutely thrilled to offer Precept in Japan, which will advance our strategy of driving the shift toward minimally disruptive approaches globally. Precept is a highly differentiated solution with advanced guide technology, superior rod insertion options, and multiple reduction capabilities. The initial reception in Japan has been fantastic, and I applaud all of the NuVasive teams who worked diligently to achieve this milestone."
The NuVasive Japan office officially opened in April 2013 in Tokyo, Japan. The office is headed by NuVasive Executive Vice President of Asia Pacific, Takaaki Tanaka. Tanaka-san has been with the Company since 2009, and brings an extensive 20 years of experience in the spine industry.