Does Duramesh™ have FDA 510(k) Clearance?
Duramesh™ received its 510(k) clearance and is available for sale in the United States.
Does Duramesh™ have CE Mark?
Duramesh™ received its CE Mark and is cleared for sale in the EU. It also has been registered with the MHRA and is for sale in the UK.
What size should I use?
Surgeons may use the same USP size that they would normally use for a standard suture. For example, if you would use a 2-0 polyblend suture, then you would use a 2-0 Duramesh. The surgeon should rely on his or her training, education, and experience for size selection.
How many knots should I tie?
Knot security requires the accepted surgical technique of at least 4 alternating throws. The initial 2 throws can be square, surgeon's, or granny without a change in knot security. A fifth throw does not add to knot security. If the surgeon fails to alternate direction (or cross) the free ends of the suture creating a multiple slip knot, at least 5 throws are required to prevent knot slippage and are not recommended. Failure to adequately secure Duramesh™ can result in dehiscence and additional surgical procedures. The knot should remain buried in soft tissues, and not immediately under the dermis, to avoid palpability and possible later knot removal. The knot should NOT be placed intra-abdominally. Knot tying should be slow and deliberate to maintain the individual filaments’ integrity and avoid stripping. Duramesh™ is cut with standard surgical scissors at least 3 mm from the surgical knot.
Can I pass Duramesh™ through itself to avoid tying a knot?
No. Do not pass Duramesh™ through itself to create a knot or for any other purposes.
Is Duramesh™ absorbable?
Duramesh™ is made from polypropylene and is non-absorbable. If you're interested in an absorbable mesh suture, please email email@example.com.
Can I use Duramesh™ robotically?
Yes, each USP size of Duramesh™ has a needle that fits through an 8mm trocar.
How can I order Duramesh™?
For USA Customers:
Request an account at https://meshsuture.com/account/register.
For OUS Customers:
Contact your local distributor to see if they carry Duramesh, or email firstname.lastname@example.org for more information.