Hemocompatibility Testing

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.