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Frequently Asked Questions

  • Is the device reusable or single-use?
    The MaxTack™ device is single-use.
  • What is the port size recommendation for the MaxTack™ device?
    The device may be inserted through a 5 mm cannula, or a larger cannula with the use of a converter, for use in minimally invasive procedures.1
  • How many tacks are included with the MaxTack™ device, and what is the significance of the two different tack colors they come with?
    MaxTack™ devices come with a total of 30 absorbable tacks that include two tack colors, 25 violet tacks followed by 5 green tacks, to indicate when the tack count runs low.2,3
  • Are the tacks absorbable?
    Yes, the tacks are absorbable. MaxTack™ device tacks are made of copolymer poly(glycolide-co-L-lactide) (PGLA). This copolymer degrades and is absorbed by hydrolysis as glycolic acid and lactic acid, which are then metabolized by the body.4,†
  • How long does it take for the tacks to absorb?
    The absorption profile of PGLA in the first two weeks after initial implantation is minimal, with a significant absorption rate seen in the period from three months to five months after implantation. Following this significant breakdown, the copolymer absorption is essentially completed prior to one year after implantation.4,†
  • Are the MaxTack™ device tacks compatible with MRI?
    Nonclinical testing demonstrated that a representative polymer tack is MRI-safe. A patient with these tacks can be scanned safely immediately after placement of the tack(s). In nonclinical testing, there is no detectable image artifact caused by the polymer tack.

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  • Nonwoven, non-porous, or biologic prosthetic materials may compromise full engagement of the tack. The prosthetic material should be carefully evaluated prior to application. A minimum thickness of tissue over underlying bone, vessels, or viscera is needed for full engagement of the tack. The total distance from the surface of the tissue (including the material to be fixated) to the underlying bone, vessels, or viscera should be carefully evaluated prior to application of the device. Tacking into tissues that have a direct anatomic relationship to major vascular structures could result in critical injury to cardiac tissues or other major vascular structures. Depressing the trigger button when not in approximation to mesh and/or tissue will cause the device to deploy a tack, which could potentially fall into the body cavity.

  • † Based on benchtop data, not necessarily indicative of human clinical outcomes.

  • 1. Based on internal report #RE00265771, MaxTack™ device shaft length spec. August 2020.

  • 2. Based on internal report #RE00437048, MaxTack™ device fixation strength claims. January 2023.

  • 3. Based on internal report #RE00339412 MaxTack™ tack colors (violet and green) justification. May 2021.

  • 4. Based on internal report #RE00438086, MaxTack™ device in-vitro mass loss study. December 2022.

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