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RemS

Novel Sub-urethral Sling

Field:

Urology / Uro-Gynecology

Description:

The use of synthetic suburethral/midurethral slings is an accepted procedure for the treatment of Stress Urinary Incontinence.  Innoventions developed a revolutionary Removable Sling design that in case of need allows readjustment and also its easy removal even months or years after its implantation.

Although very effective, all currently available suburethral/midurethral slings have an inherent character  of being strongly imbedded into the surrounding tissues and if the need for removal arises it  necessitates a difficult and complicated surgical procedure.

Innoventions patented novel sling is made of the same materials used in the other current slings, is as strong as them but about half their thickness, and  its proprietary design allows its easy removal.

 

Medical Slings.    PCT/ IL2013050973  + National Phase Applications US Patent : 9,872,753 (Granted – Jan. 23, 2018)

 

Need:

About 20% of patients who are implanted a synthetic sling for the treatment of Stress urinary Incontinence complain of some degree of pain, discomfort during sexual intercourse (dyspareunia), sling erosion or fistula formation. Thousands of lawsuits were initiated by these patients which resulted in compensations costing millions of dollars to the companies. These could be prevented or minimized if the sling could be removed by a minimally invasive procedure.

 

Advantages:

  • Novel, easily removable sling

  • Similar procedure as the current sling implantation (TVT or TOT)

  • Minimal need for physician re-training
     

R&D status:

Several Designs - Bench tested

 

IP status:

Medical Slings. PCT/ IL2013050973  + National Phase Applications US Patent: 9,872,753 (Granted – Jan. 23, 2018)

Patent: CN 104955419B (Granted – Sep. 08, 2017) China Patent

Business opportunity:

The analysts forecast the Urinary Slings market in the US to grow at a CAGR of 11.85 percent over the period 2014-2019.

Market data suggests that in 2010 approximately 75,000 women received POP mesh repair and at least 208,000 women had mesh for SUI surgeries (U.S. Food & Drug Administration. FDA safety communication: update on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse. July. 2011; 13:2011.)

In early 2016, the FDA reclassified transvaginal mesh used for POP as a Class III device. (Food and Drug Administration , HHS. Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair; Final order. Fed Regist 2016;81:353-61).

This reclassification did not include mesh for SUI. In the 2013 update the FDA had clearly stated “the safety and effectiveness of multi-incision slings is well-established in clinical trials that followed patients for up to one-year”.