1st in Human Use – CystoSure® Urinary Access System

1^st in Human Use for CystoSure^® Urinary Access Catheter System for Female Cystoscopy 

System Represents the First New Approach for Cystoscopy in Decades

Emmy Medical, LLC announced today that the first human uses of the CystoSure® system for female cystoscopy have been completed. CystoSure® provides a simple, safe and efficient means for conducting cystoscopy at the office, in the operating Room, or at the bedside.

Cystoscopy is a commonly performed procedure used in the hospital and office to diagnose lower urinary tract conditions. Traditional cystoscopy is complicated and cumbersome, preventing widespread use even when indicated. CystoSure®’s patent pending design, specifically designed for the female patient and their healthcare providers, reinvents the game – providing a technique which is safe, simple, and standardized.

“Over a million gynecologic and urogynecologic procedures are performed annually in this country which have a risk or urinary tract injury but few undergo routine cystoscopy despite recommendations from our professional societies,” according to Jim Greenberg, MD and inventor of CystoSure®. “Nothing has changed for female cystoscopy in the last 100 years so I created CystoSure® to offer a simpler and easier means for doctors to scope patients.”

The CystoSure® system consists of two components: an 18 French 4-Way catheter and a small scope.  CystoSure’s proprietary design allows multiple passes of the scope to visualize the bladder while lowering risk of trauma or infection to the urethra/bladder and improving patient comfort. In addition, the catheter design allows full and consistent bladder evaluation with a simple rotation of the scope, obviating the need for a learning curve or cystoscopy experience. According to Neeraj Kohli, MD, MBA, Chief Medical Officer, “CystoSure® is a game changer. We have utilized it for procedures in the office and OR and it makes cystoscopy more accessible to physicians and patients alike while making the procedure safer, faster, and easier saving doctors and hospitals valuable time and money.”

John Miklos, MD a recognized expert in the diagnosis and treatment of female urogynecologic conditions has utilized CystoSure® in multiple OR cases and offers “Cystosure offers us the ability to maintain bladder drainage throughout procedures with the capability of scope insertion for a diagnostic inspection of the bladder at any time. We are excited about the potential to expand its use to the office where it can enhance our ability to conduct cystoscopies in a safe and simple manner.”

CystoSure® is now commercially available to medical professionals in the United States.

About Emmy Medical LLC 

Emmy Medical LLC, based in Boston, MA, has developed the world’s first female specific cystoscopy system. The CystoSure® system utilizes a flexible urinary catheter to establish an access pathway and incorporates a proprietary scope port which enables the clinician to conduct diagnostic cystoscopy without needing to remove the drainage catheter. Emmy Medical was formed in August, 2013 by a team of forward thinking doctors and seasoned medical device executives. Visit us on the web at www.cystosure.com.

Safety information for CystoSure® therapy is provided at www.cystosure.com. CystoSure® is not for everyone. Information at this site should not be used as a substitute for patients talking with their doctor. Patients are encouraged to review this safety information and talk with their doctor about diagnosis options.

Media contact: 

Ron Adams
President, Emmy Medical
775-800-7300
Ron@cystosure.com