Solbiate Olona (VA) - Italy - June 23rd , 2009
Quanta System announces the awarding of the 510(k) clearance, released by the FDA Authorities, for the Cyber series family.
Cyber Green is a high power green (532 nm) laser for BPH (Benign Prostate Hyperplasia), performing hemostasis and tissue vaporization. Together with several other urology applications, it also performs Gastroenterology, Gynecology, ENT, Neurosurgery, Ophthalmology, Plastic Surgery and Spinal Surgery.
Cyber TM is a high power Thulium:YAG laser (2010 nm) for many applications in the surgical field, including Urology, Gastroenterology, Thoracic and Pulmonary, ENT, Gynecology, General Surgery and Arthroscopy. Quanta's Thulium:YAG laser is ideal for BPH applications, for its incomparable high speed and the intrinsic safety (high absorption made by water).
It also performs vapo-resection and enucleation of prostatic tissues, allowing surgeons to make histology, as well. Thulium can also work in pulsed mode, allowing treatments of urethral, bladder and renal stones.
For the Cyber series they have been developed special proprietary side firing fibres. Quanta supplies also frontal fibres for contact applications. "Today is great for all of us. We have achieved a very important target.
This step is another brick in the construction of our presence in the surgical field in the USA and North America" said Dr. Isabella Carrer, Medical Division Manager and FDA official correspondent on behalf of Quanta.
"A strong improvement of our know-how and R&D capabilities have launched Quanta in the high-end diode pumped scenario, with a significant rebound into medical applications, too" commented Dr. Fabio Ferrario, executive director of Quanta System.
"After several investments in technology and marketing, which have also seen our presence in two exhibitions of world-wide importance, this year (the European Urology Congress - Stockholm, and the AUA - American Urology Association - Chicago), we are finally in the position to properly launch our products at world-wide level, with a particular focus into the USA market. The launch of our surgical line will highly contribute to enforce our presence in the laser medical scenario, allowing Quanta System to gain larger market shares" has been the final coral comment of both the General Manager (Dr. Paolo Salvadeo) and of Dr. Angelo Ferrario, president of Quanta System.
* * *
Quanta System SpA was founded in 1985 and has been part of El.En group (listed on the Milan Star Stock Exchange) since January 2004. As Italian company, strongly oriented to internationalization, Quanta System has strengthened with years its presence on the markets throughout the world; it is currently organized into three business units: industrial, medical and scientific divisions.
Quanta System designs and manufactures sophisticated laser and opto-electronics devices.