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The Assessment Of A Novel Minimally Invasive Targeted Resection (mitr) Device In A Porcine Lung Model: A 30-day Study
Richard J. Fischel1, Lance M. Black
2, Fergus F. Wong
3, Joanna C. Nathan
4, Richard T. Miller
5, Edward M. Boyle
6.
1University of California Irvine, Irvine, CA, USA,
2Texas A&M University, College Station, TX, USA,
3Prana Surgical, Houston, TX, USA,
4Rice University, Houston, TX, USA,
5CommonSpirit Cardiac & Thoracic Surgery, Colorado Springs, CO, USA,
6St. Charles Medical Center, Bend, OR, USA.
BACKGROUND:
The MiTR device is a novel surgical instrument designed for transthoracic pulmonary tissue resection through a single port of entry, using bipolar radiofrequency energy. This study aimed to evaluate the efficacy, safety, and tissue response of the MiTR device in a porcine model over a 30-day post-procedural period.
METHODS:
A chronic study was performed using five domestic pigs under GLP-like conditions. Lung tissue resections were conducted with the MiTR device, followed by application of an aerostatic sealant. Postoperatively, all animals were monitored for 30 days for clinical recovery. Comprehensive necropsy and histopathological evaluations assessed tissue healing, thermal injury, and inflammation. Gross pathology and histology examined fibrosis, necrosis, hemorrhage, and inflammatory response at resection sites and excised tissue.
RESULTS:Intraoperative Observations:
- Air Leaks: All animals exhibited a Grade 1 air leak immediately after resection. Application of the sealant resolved air leaks in all cases. Chest tubes were placed intraoperatively and removed uneventfully on postoperative day 1.
- Bleeding: All animals deonstrated no bleeding, or Grade 1 bleeding, within 5 minutes of observation. No additional hemostatic measures were required apart from application of pressure on one animal.
- Tissue Resection: The resected lung tissue met expected dimensions and morphology, confirming the device’s precision.
Postoperative Observations:
All 5 animals recovered without significant complications; no abnormalities were noted during the survival period.
Gross Pathology:
Fibrous adhesions were noted at resection sites in three animals. No signs of infection or poor healing were observed.
Histopathology:
Thermal injury at resection margins was minimal to mild. Fibrosis with neovascularization and a mild inflammatory infiltrate (macrophages, lymphocytes, PMNs) was observed at resection sites. Granulomatous inflammation centered on foreign material (textile fibers, skeletal muscle) was noted in some cases.
CONCLUSIONS:The MiTR device enabled effective lung tissue resection with localized and limited thermal injury. Post-resection healing was consistent with expected surgical responses, characterized by fibrosis and mild inflammation. The absence of significant clinical pathology findings supports the safety profile of the MiTR device, warranting further investigation in controlled clinical studies to optimize performance and procedural safety.
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