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Market Comparison

12 months ago
Mid-Urethral Mesh Sling Artificial Urinary Sphincter PMD Flow Control
Amount of training required by surgeon? (1) Significant Very Significant Moderate
Company personnel needed during surgery? No Yes No
Number of Deep Implant Sites 1 3 1
Number of Subcutaneous Implant Sites 0 0 1
Time it takes to implant? (2) 30 – 45 minutes 1.5 – 3 hours 15 – 20 minutes
How is closure pressure on urethra set? Educated Guess; Cough Test Educated Guess Telemetry
Remotely adjustable after implant? No No Yes
Open/close mechanism? No Yes Yes
User friendly? No No Yes
Type of surgical procedure? (3) Out-Patient In-Patient Same-Day
Can patient be catheterized after implant? No No Yes
“Failsafe” systems for “too tight” settings? No No Yes
Procedure for correcting Malfunctioning product Surgical Removal In-Patient Surgical Removal In-Patient Replace Control Box Out-Patient
Time it takes to correct Malfunctioning product 45 – 90 minutes 1.5 – 3 hours 15 – 20 minutes
Any specific requirements for patients to qualify for implant of product? No Patient must be cognitive & physically capable of triggering No
Tension free? No Yes Yes
Designed to treat severe cases of incontinence? No Yes Yes

Footnotes to Chart

(1) Amount of training required by each surgeon is based upon not only the difficulty-level of the procedure itself, but also factors into the estimate, the difficulty in deciding on the amount of urethra compression required by each patient undergoing the surgical procedure and the prospective amount of time it may take for each surgeon to reach an adequate skill level on making those settings choices such that the procedure would result in a more appropriate level of success.

(2) The time it takes to complete any implant procedure can vary drastically as a result of the level of skill of the surgeon, the prospective complications encountered in any specific surgical procedure and the design of the implant product or procedure itself. Some of the time estimates are being based upon information found in specific studies, but are also enhanced by the estimates made of some average amount of time that would likely be required to complete the procedure itself, as well as, the time it might take to make the decision on the amount of compression to use on the urethra for any given patient.

(3) The type of surgical procedures required to implant the urethral sling and the artificial sphincter device have all been described in numerous medical journal articles, while the surgical procedure to implant the PMD device is being estimated based upon its having been done in an animal model.