Cardiovascular devices include a wide array of products that contact the vasculature or the heart in one way or another. The device could be as simple as an intravenous catheter for delivering fluids to the patient, or as complex as arterial or cardiac implants. The device may have blood and soft tissue exposures, such as a pacemaker with a heart/blood contact lead, but also may contain an implanted battery source that does not contact blood.
Depending upon the exact nature of the device, a range of biological effects may have to be evaluated (See ISO 10993). For example, vascular devices which will have less than 24 hours exposure to the blood, vasculature or the heart would require less scrutiny than a permanently implanted stent or heart valve. In addition to the usual questions related to testing requirements, one needs to thoroughly address blood compatibility. The effect that the device might have on formed elements (various blood cells), clotting factors and thrombogenicity may need to be known. NAMSA scientists can best determine the extent and type of blood compatibility testing to perform once the nature of the device is known. Not all devices, no matter how similar, require the same testing program. Each device is examined anew and the testing program proposed to meet the unique requirements of each device.
NAMSA Technical Specialists and Scientists are adept at developing non-clinical testing programs for such products. Veterinary surgeons on staff are experienced at implanting and evaluating the biocompatibility and functionality of such devices.
Standards and Regulation
First consideration should be given to vertical standards (an FDA guideline or ISO standard that is specific for a given device). In the absence of such guidance, ISO 10993 should be consulted to determine potential areas of concern for these devices.
