Key Milestones for Cogentix Medical


2015

Uroplasy and Vision Sciences is now Cogentix Medical

Uroplasty, Inc. and Vision-Sciences merge to form Cogentix Medical. Cogentix Medical incorporated in the state of Delaware.

EndoSheath® Technology is included in the 2015 ANSI/AAMI National Standards for flexible and semi-rigid endoscope processing in health care facilities.


2014

National Medicare reimbursement for PTNS with Urgent PC.

Vision-Sciences introduces smallest diameter flexible video laryngoscope to the Ear-Nose-and Throat Market.

Urgent PC is upgraded to a recommended therapy in the AUA/SUFU OAB guideline. 


2011

Category 1 CPT Code, 64566, specific to PTNS, effective January 1, 2011.

The United Kingdom's National Institute of Clinical Excellence (NICE) issues a guidance for the use of PTNS in the treatment of Fecal Incontinence. Urgent PC is not cleared for the treatment of fecal incontinence in the United States.


2010

The United Kingdom's National Institute of Clinical Excellence (NICE) issues a guidance for the use of PTNS in the treatment of Overactive Bladder.

The American Medical Association establishes a new Category I CPT Code, 64566, specific to PTNS.


2009

EndoSheath® Cystoscopy is included in the Joint AUA/ SUNA White Paper on Reprocessing of Flexible Cystoscopes.

Vision-Sciences receives FDA clearance for the first generation video EndoSheath® Bronchoscopy system.

Vision-Sciences launches its next generation 4000 Series fiberoptic EndoSheath endoscope line, featuring system for cystoscopy, bronchoscopy, and laryngoscopy.


2007-2009

Randomized studies are conducted comparing Urgent PC to medical and sham treatment.


2007

5000 Series Video Endoscopy platform

Vision-Sciences Orangeburg facility underwent an expansion audit which was successfully completed resulting in ISO 13485: 2003 certification.

Vision-Sciences receives FDA clearance for several 5000 Series Video Endoscopy platforms utilizing EndoSheath® Technology. Video systems for cystoscopy, hysteroscopy, esophagoscopy, and laryngoscopy are all launched to market.

Vision-Sciences also receives clearance for the 5000 Series Vision System®, the endoscopy market’s first all-in-one high performance visualization platform for endoscopy.


2006

Urgent PC with new control interface by Cogentix Medical

Uroplasty develops the next generation of Urgent PC featuring a new control interface and an ergonomic design.

The FDA grants PMA approval to Macroplastique for the treatment of female stress urinary incontinence (SUI) primarily due to intrinsic sphincter deficiency (ISD).


2005

The Macroplastique IDE study is completed.

Uroplasty updates the Urgent PC technology and obtains 510(k) clearance for the Urgent PC stimulator and lead set.

Uroplasty begins to commercialize Urgent PC in the United States for the treatment of overactive bladder and associated symptoms of urinary urgency, urinary frequency and urge incontinence.

Vision-Sciences quality system certification for the Natick location is updated in conformance with ISO 13485: 2003 and continues conformance with Medical Devices Directive (MDD) 93/42/EEC and the Canadian Medical Device Regulations (CMDR).


2005

Vision-Sciences receives FDA clearance and launches the BLS-1000, the endoscopy market’s first rechargeable, battery-powered LED light source.


2004

Uroplasty signs a licensing agreement with Cystomedix, Inc. to acquire the Urgent PC technology, the only FDA-cleared product to deliver percutaneous tibial nerve stimulation (PTNS) for the treatment of Overactive Bladder and the associated symptoms of urinary urgency, urinary frequency and urge incontinence.

Vision-Sciences receives FDA clearance and launches first generation EndoSheath® Cystoscopy platform.


2003

Vision-Sciences receives FDA clearance for first generation Transnasal Esophagoscopy system with EndoSheath® Technology.


2002

Macroplastique PTQ implants by Cogentix Medical

Macroplastique earns CE Mark approval for PTQ implants, a tissue bulking agent used for the treatment of fecal incontinence.

Uroplasty changes the name of Bioplastique to VOX Implants for vocal cord rehabilitation.


2000

Macroplastique IDE

The first patient is enrolled in the Macroplastique IDE clinical study. Enrollment for this two year study continues until 2003.

The MIS receives CE Mark approval in the European Union.


1999

The FDA grants Investigational Device Exemption (IDE) approval to initiate a clinical study of Macroplastique for the treatment of female stress urinary incontinence in the USA.

The Macroplastique Implantation System (MIS) is developed to facilitate non-endoscopic placement of Macroplastique for female SUI treatment.

Vision-Sciences receives FDA clearance for next generation “Slide-On” EndoSheath® Technology.


1998

Macroplastique is approved for sale in Canada.


1996

Macroplastique is the first tissue bulking agent to gain CE Mark Authorization in Europe. Uroplasty also receives CE Mark Authorization for the tissue bulking agent Bioplastique used for vocal cord rehabilitation.

The first peer-reviewed publication describing 3 year follow-up results for Macroplastique for the treatment of SUI is published in the British Journal of Urology.


1995

Uroplasty's quality system receives ISO 9001 certification from AMTAC Certification Services (now a subsidiary of Intertek).


1991-1994

Urologists from the United Kingdom present their initial results using Macroplastique at worldwide Urology conferences including the American Urological Association (AUA), the International Continence Society (ICS), and the European Association of Urology (EAU).


1992-1993

EndoSheath® Technology

Vision-Sciences receives first FDA clearances for the EndoSheath® Technology.


1992

Uroplasty

Uroplasty is incorporated in the state of Minnesota to focus exclusively on the development of Macroplastique and other tissue bulking agent solutions.

Uroplasty opens its European Headquarters based in The Netherlands (Uroplasty BV).


1991

Macroplastique product

Macroplastique is first used in the United Kingdom for the treatment of Vesicoureteral Reflux (VUR) and Stress Urinary Incontinence (SUI).


1988-1991

Arthur Beisang, Jr., Robert Ersek, M.D., and Arthur Beisang III, M.D., invent and refine a process for suspending textured silicone elastomer implants in a PVP hydrogel. This technology was used to create a tissue bulking agent that would become Macroplastique.


1987

Vision-Sciences Incorporated

Vision-Sciences incorporated in the state of Delaware and opens its headquarters in Natick, Massachusetts.