ALISO VIEJO, Calif., July 6 /PRNewswire/ -- FastSize LLC has received “CE marking” permission for its Extender device. The marking authorization means that the device, a non-surgical, mechanical traction treatment for Peyonie’s Disease and phalloplasty, can now be marketed throughout the European Union.
The CE marking process includes a rigorous examination of quality manufacturing procedures and indicates to the public that the marked device meets standards set by the Union for medical devices.
“Until now only one other similar device has been available in Europe for the treatment of Peyronie’s Disease and for non-surgical phalloplasty,” said FastSize marketing VP Mike Hays. “Now patients will have a choice of devices, and the aggressive pricing FastSize will bring to the European market means that patients will benefit from lower costs for treatment in the future.”
Peyronie’s Disease, growth of scar-like tissue that causes an unnatural bend in the penis during the erection process, can be mild to debilitating. More and more cases are being reported in Europe and the U.S., resulting in increased attention from the medical profession.
In Europe, mechanical traction has been used successfully to treat Peyronie’s Disease for a number of years. FastSize LLC brought the treatment protocol to the U.S. last year. It is now undergoing medical trials at Urology Specialists of Chicago under the direction of Dr. Laurence Levine, acknowledged as one of the top researchers on Peyronie’s treatments in the U.S.
It was Levine who first noted the rising trend in reports of Peyronie’s in the U.S. Once thought to be as little as three percent of the population, Levine’s estimate is now nine percent. This trend is mirrored in Europe and is thought to be largely due to an increased willingness on the part of men to discuss sexual issues with their physicians.
Phalloplasty, or enlargement of the penis, is increasingly desirable as a self-image issue for European and American males. In the past, the only recourse for men was plastic surgery with its partial success rates and considerable risks. Mechanical traction as provided by the Extender device applies a small pressure over time, gently -- and non-surgically -- enabling gains in length of one inch and above.
“The popularity of this device is well-known throughout Europe,” said Hays. “Now, FastSize will be able to make the treatment available at lower costs in all 25 EU member states, plus the EFTA countries Norway, Switzerland, Iceland, and Liechtenstein.”
Source: FastSize LLC
