For PhysioTel and PhysioTel Digital:
- The suppliers of the raw materials used to manufacture the implants have performed hemocompatibility testing.
- The treatment chemicals and processes have not changed.
- DSI has performed histopathology on the implant body sites.
Material comparison between D70s and PhysioTel Digital
The following apply to the catheters on PCT, PCTP, L-series and M-series implants:
- The last material change occurred in ~2003 with the release of the PCTP catheter stems.
- Tubing sizes, tip material, and surface treatments are the same across all implants in this category.
- All of these materials have a long history of use in medical devices, including DSI's own use.
- How the catheters are assembled, cleaned, and treated are consistent across all the catheters.
- The stem and tip outer diameters are the same across all catheters.
Tip OD = 0.055” (4.19 Fr) , STEM OD =0.045” (3.43 Fr), Tip cover ID on all is 0.051” with a 0.03” wall.
- Jason S. Cordes, Jonathan R. Heyen, Marlo L. Volberg, Nancy Poy, Steven Kreuser, Ahmed M. Shoieb, Jill Steidl-Nichols. (2016). "Validation and utility of the PhysioTel™ Digital M11 telemetry implant for cardiovascular data evaluation in cynomolgus monkeys and Beagle dogs." Journal of Pharmacological and Toxicological Methods.79: 72-79. ISSN 1056-8719. https://doi.org/10.1016/j.vascn.2016.01.006.
- Ninette K. Andersen, Olivier Meyer, Alys Bradley, Nils Dragsted, Anders B. Lassen, Ingrid Sjögren, Julie M. Larsen, Warren Harvey, Rastislav Bator, Aileen Milne. (2017). "Evaluation of the PhysioTel™ Digital M11 cardiovascular telemetry implant in socially housed cynomolgus monkeys up to 16weeks after surgery." Journal of Pharmacological and Toxicological Methods. 87: 82-92. ISSN 1056-8719. https://doi.org/10.1016/j.vascn.2017.04.007.
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