PARIS--(BUSINESS WIRE)--Regulatory News:
Mauna Kea Technologies (Paris:MKEA) (NYSE Euronext: MKEA, FR0010609263) announced today that Joseph C. Liao MD, associate professor of urology, Stanford University, has successfully used endomicroscopy with Cellvizio for the first time in eight patients treated with robotic assisted radical prostatectomy (RARP) procedures. Results were presented in a poster presentation at the 2013 World Congress of Endourology Meeting in New Orleans in October where the procedure was also named “Best New Innovation.”
In the feasibility study the use of endomicroscopy with Cellvizio was shown to provide real time imaging of prostate and surrounding tissues during RARP procedures using the da Vinci Surgical System. Intraoperative probe-based confocal laser endomicroscopy (pCLE) also known as optical biopsy was successfully performed in eight patients with no related complications. According to the study results, optical biopsy with Cellvizio was shown to enable stable microscopic visualization of a range of important surgical and oncologic landmarks including neurovascular bundles, which could help surgeons identify optimal nerve-sparing techniques for RARP.
“In radical prostatectomy successful functional and oncological outcomes depend critically on our ability to identify and dissect particular tissue planes with maximum precision. The use of optical biopsy can provide surgeons with the ability to better visualize and confirm important anatomic landmarks including neurovascular bundles, which can play an important role in intraoperative guidance and potentially improve outcomes for patients,” said Dr. Liao.
Following RARP, intact prostates, prostate slices and cores were imaged in 11 patients. Ex vivo imaging of prostate tissues revealed characteristic stromal and glandular microarchitecture in unfixed tissue. Precise pathological correlation was successfully achieved with optical biopsy imaging of prostate needle cores.
“These recent results in patients treated with robotic prostatectomy indicate that optical biopsy with Cellvizio could also play a role in treatment for many patients with prostate cancer. Improved visualization of prostate and related tissue could help surgeons reduce the risk of nerve trauma associated with prostatectomy and is another reflection of the versatility and broad potential applications of the Cellvizio technology platform,” said Sacha Loiseau, founder and CEO of Mauna Kea Technologies.
At the same meeting Dr. Liao also presented the conference's keynote imaging lecture entitled “Optical Biopsy of Urothelial Carcinoma with Confocal Endomicroscopy”, in which he reviewed the latest clinical work involving the use of Cellvizio for bladder cancer characterization and its potential for improvement of patient outcomes.
The use of Cellvizio in urological indications has been awarded a CE Mark in Europe. Cellvizio is an investigational product pending FDA clearance in the United States for use in urological indications. Cellvizio is designed with a range of confocal miniprobes for applications in endourology, including flexible cystoscopy, rigid cystoscopy and ureteroscopy.
About Robotic Assisted Radical Prostatectomy (RARP)
Prostatectomy is the surgical removal of all or part of the prostate gland. According to the Centers for Disease Control more than 138,000 prostatectomies are performed in the United States each year. The da Vinci Surgical System is a robotic surgical system designed to facilitate complex surgery using a minimally invasive approach. The da Vinci Surgical System is currently used in 4 out of 5 radical prostatectomies in the U.S. and is present in more than 2,000 hospitals in the US.
About Mauna Kea Technologies
Mauna Kea Technologies is a global medical device company dedicated to the advent of optical biopsy. The company researches, develops and markets innovative tools to visualize and detect cellular abnormalities during endoscopic procedures. Its flagship product, Cellvizio®, a probe-based Confocal Laser Endomicroscopy (pCLE) system, provides physicians and researchers high-resolution cellular views of tissue inside the body. Large, international, multicenter clinical trials have demonstrated Cellvizio's ability to help physicians more accurately detect early forms of disease and make treatment decisions immediately. Designed to improve patient outcomes and reduce costs within a hospital, Cellvizio can be used with almost any endoscope. Cellvizio has 510(k) clearance from the U.S. Food and Drug Administration and the European CE-Mark for use in the GI tract, biliary and pancreatic ducts and lungs and during fine needle aspiration procedures.
For more information on Mauna Kea Technologies, visit www.maunakeatech.com
