Le Lézard
Classified in: Health
Subjects: TRI, MAT

Rigicon, Inc. becomes the 3rd company developing Penile Prosthesis in the US


RONKONKOMA, N.Y., Dec. 16, 2019 /PRNewswire-PRWeb/ -- Rigicon,Inc. announces that the U.S. Food and Drug Administration (FDA) has cleared Rigi10tm New Generation Malleable Penile Prosthesis for implantation into the corpora cavernosa of the penis for men who are diagnosed with erectile dysfunction. The prosthesis is implanted to provide adequate penile rigidity for sexual intercourse.

Rigi10tm (New Generation Malleable Penile Prosthesis) is easy to implant and easy to use. The Flexible Rod Technologytm enables higher bending angles with no spring-backs. Rigi10tm is offered in 5 different diameters and 2 sizes for a better fit to the patient's anatomy.

Infla10® is the next generation inflatable penile prosthesis designed with years of experience in urology. Infla10® incorporates a hydrophilic coating on all external component surfaces to facilitate rapid and strong absorption of the solution on the device and promote easier device implantation. Innovative Rapid-Pumptm mechanism offers greater ease and speed for patients when inflating and deflating the prosthesis. Infla10®AX version offers the patients anatomical girth and length expansion addressing concerns regarding post-operative penile shortening. Infla10® is currently in clincial trial phase in the US.

Penile Prosthesis is for treating erectile dysfunction, a condition affecting more than 200 million men annually worldwide, with nearly 50% of men over 60 suffering from moderate to severe symptoms.[1,2]

About Erectile Dysfunction
Erectile Dysfunction, or ED, is the inability to achieve or sustain an erection suitable for sexual intercourse. ED is actually a common male sexual disorder and may maintain a permanent course as some men cannot have any erection for the remaining part of their life. ED might have a deep impact on the quality of life and social relationships of the patient.

ED may be basically caused by various diseases and disorders including heart disease, diabetes, pelvic area damage due to surgery, accidents or radiation therapy, benign prostatic hyperplasia (BPH, which is non-cancerous enlargement of the prostate tissue), disorders associated with low testosterone levels, Parkinson's disease, and other neurologic diseases.

About Malleable Penile Prosthesis (Semi-Rigid Penile Prosthesis)
Malleable penile prosthesis is a medical device that allows an impotent male to achieve an erection. The malleable implant consists of two rods that are always hard but pliable. All components are concealed within the body and cannot be seen from the outside. The penile implant cylinders reside in the penis on either side. No tissue is removed to place the rods; the rods simply occupy spaces that were previously filled with blood, when one was potent. The rods do not disrupt the flow of urine or ejaculate. The rods do not alter the sensation of the penis.

About Inflatable Penile Prosthesis (Three - Piece Inflatable Penile Prosthesis)
Inflatable devices, the most common type of penile implant used, can be inflated to create an erection and deflated at other times. Three-piece inflatable implants use a fluid-filled reservoir implanted under the abdominal wall, a pump and a release valve placed inside the scrotum, and two inflatable cylinders inside the penis. (Source:Mayo Clinic)

Penile implant surgery is considered a gold standard therapy for men with erectile dysfunction.

About Rigicon®

Rigicon® designs and manufactures innovative urological implants with 30 years experience on Urology. We focus on creating a comprehensive product portfolio for urologist(s) around the world. Our commitment is to deliver high quality and innovative urology products to our valued patients and physicians.

Find out more at http://www.rigicon.com
Contact
Rigicon Media Affairs
+ 1(631) 676-3376 Ext: 301
+ 1(888) 202-9790
operations@rigicon.com
customerservice@rigicon.com
[1] US Census Bureau.
[2] Aytac IA et al (1996) - The likely worldwide increase in erectile dysfunction between 1995 and 2025 and some possible policy consequences. BJUI, 84: 50-6.

 

SOURCE Rigicon


These press releases may also interest you

at 11:23
Today, Samaritan's Purse deployed its Emergency Field Hospital to New York City, New York, where the local medical infrastructure is severely overwhelmed. In cooperation with the Federal Emergency Management Agency (FEMA), New York state officials,...

at 11:01
Novartis today announced results from a prespecified analysis of pooled data from three Phase III studies evaluating the safety and efficacy of inclisiran, its first-in-class investigational treatment for hyperlipidemia in adults. The data was...

at 11:00
As the impact of the Coronavirus (COVID-19) is now felt worldwide, we want to assure our customers and partners that we are still here to support you. Zenner's operations remain open with regular operating hours. Zenner's number one priority is...

at 10:13
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the VOYAGER PAD study met its primary efficacy and principal safety endpoints, demonstrating the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily) plus aspirin (100 mg...

at 10:05
Merck , known as MSD outside the United States and Canada, today announced the presentation of results from the VICTORIA trial, a Phase 3 study evaluating the efficacy and safety of its investigational drug vericiguat, an orally administered soluble...

at 10:00
Amgen today announced positive results from the EvolocumaB Effect on LDL-C LowerIng in SubJEcts with Human Immunodeficiency ViRus and INcreased Cardiovascular RisK (BEIJERINCK) study evaluating the efficacy and safety of Repatha® (evolocumab) in...



News published on 16 december 2019 at 07:00 and distributed by: