Anterior cruciate ligament reconstruction in a translational model in sheep using biointegrative mineral fiber reinforced screws.

Anterior cruciate ligament reconstruction (ACLR) is one of the more common procedures performed worldwide and perhaps the most widely studied construct in orthopedic literature. Interference screws are reliable and frequently used for ligament reconstruction, providing rigid fixation and facilitates graft incorporation allowing for the physiologic loads of early rehabilitation. The purpose of this study was to determine the bio-integration profile and quality of soft tissue graft when using mineral fiber-reinforced screws in an ACLR interference model.

Scientific and Regulatory Policy Committee Points to Consider for Medical Device Implant Site Evaluation in Nonclinical Studies.

Nonclinical implantation studies are a common and often critical step for medical device safety assessment in the bench-to-market pathway. Nonclinical implanted medical devices or drug-device combination products require complex macroscopic and microscopic pathology evaluations due to the physical presence of the device itself and unique tissue responses to device materials. The Medical Device Implant Site Evaluation working group of the Society of Toxicologic Pathology's (STP) Scientific and Regulatory Policy Committee (SRPC) was tasked with reviewing scientific, technical, and regulatory considerations for these studies.

6-Month Evaluation of a Transcatheter Aortic Valve (Myval) in a Novel Ovine, Supra-Aortic Banding Model.

The aim of the study was to evaluate a balloon expandable transcatheter heart valve (THV) system (Myval) at 6-month follow-up in ovine banding model. Eleven THV systems were implanted via carotid approach. There were 2 procedure-related deaths and 2 premature deaths.

Chronic myocardial and coronary arterial effects of intracoronary supersaturated oxygen therapy in swine with normal and ischemic-reperfused myocardium.

The study assessed chronic myocardial, coronary and systemic effects of intracoronary supersaturated oxygen (SSO) therapy. Left anterior descending coronary arteries of 40 swine were stented and randomized to 90-min selective intracoronary infusion of SSO (pO 760-1000 mmHg) or normoxemic saline. In 20 out of 40 animals, SSO delivery followed a 60-min balloon occlusion to induce myocardial infarction (MI).

In vivo safety study using radiation at wavelengths and dosages relevant to intravascular imaging.

Significance: Intravascular photoacoustic (IVPA) imaging can identify native lipid in atherosclerotic plaques in vivo. However, the large number of laser pulses required to produce 3D images is a safety concern that has not been fully addressed.

Aim: We aim to evaluate if irradiation at wavelengths and dosages relevant to IVPA imaging causes target vessel damage.