TransMedics launches pivotal trial for OCS liver transplant system

TransMedics said today that it launched a pivotal study of its OCS Liver device, which is designed to keep donated human liver warm and perfused until transplantation. Andover, Mass.-based TransMedics said the 1st liver transplantation using OCS Liver was performed at Mass. General Hospital by Dr. James Markmann, a lead investigator for the 300-patient OCS Liver Protect trial and chairman of its steering committee. “It is our hope that the ability to preserve a liver in the manner offered by the OCS technology will save lives by making the livers we use function better and by making more organs available for transplantation,” Markmann said in prepared remarks. The OCS Liver Protect study is designed to compare liver transplantation using the TransMedics device with the standard of care – transplantation using a liver preserved on ice. Its primary endpoints are incidence of early liver allograft dysfunction at 7 days and incidence of liver graft-related serious adverse events at 30 days. Final data collection for the primary endpoint is slated for October. “This is a significant milestone for TransMedics, as it represents the introduction of our 3rd product platform (in addition to our OCS Lung and OCS Heart platforms), and significantly expands our overall addressable market potential. It solidifies our market leadership position given that OCS is the only multi-organ platform in the market world-wide,” president &CEO ...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Surgical Organ Transplant Transmedics Inc. Source Type: news

Related Links:

ConclusionThough the majority of faculty desired POF, developing a supportive environment and feasible program is challenging. This study provides considerations for improving and designing POF programs.
Source: Academic Pediatrics - Category: Pediatrics Source Type: research
Publication date: Available online 9 March 2019Source: The Journal of Molecular DiagnosticsAuthor(s): Maristela L. Onozato, Clarence Yapp, Douglas Richardson, Tilak Sundaresan, Varun Chahal, Jesse Lee, James P. Sullivan, Marisa W. Madden, Hyo S. Shim, Mathew Liebers, Quan Ho, Shyamala Maheswaran, Daniel A. Haber, Zongli Zheng, Brian Clancy, Hunter L. Elliott, Jochen K. Lennerz, A. John IafrateThe quantification of changes in gene copy number is critical to our understanding of tumor biology and for the clinical management of cancer patients. DNA fluorescence in situ hybridization is the gold standard method to detect copy ...
Source: The Journal of Molecular Diagnostics - Category: Pathology Source Type: research
Publication date: April 2019Source: Pathology - Research and Practice, Volume 215, Issue 4Author(s):
Source: Pathology Research and Practice - Category: Pathology Source Type: research
Publication date: Available online 23 March 2019Source: The Journal of Foot and Ankle SurgeryAuthor(s): Evelyn Heigh, Laura Bohman, Gary Briskin, Michael Slayton, Richard Amodei, Keegan Compton, Bob BaravarianAbstractIntense therapeutic ultrasound for chronic plantar fasciitis musculoskeletal tissue pain reduction was evaluated in a pivotal clinical trial examining effectiveness, safety, and patient tolerance. In this single-blinded study, 33 patients received 2 treatments that were 4 weeks apart on plantar fascia tissue along with conservative standard of care. Patients were followed for up to 6 months after the first tre...
Source: The Journal of Foot and Ankle Surgery - Category: Orthopaedics Source Type: research
Publication date: Available online 23 March 2019Source: The Journal of Foot and Ankle SurgeryAuthor(s): Susan M. Ge, Yousef Marwan, Abdullah Addar, Nizar Algarni, Ruth Chaytor, Robert E. TurcotteAbstractOsteoid osteomas (OOs) are rare benign bone tumors that may occur in various joints including the ankle. These tumors are generally removed via open surgical excision or radiofrequency ablation. However, when they occur intra-articularly, these treatments are more difficult to perform because of more difficult access and the increased risk of damaging articular cartilage. Therefore, some have advocated for the use of arthro...
Source: The Journal of Foot and Ankle Surgery - Category: Orthopaedics Source Type: research
This study shows promise for viscosupplementation with NASHA in the treatment of ankle OA. A single injection was associated with clinically meaningful reductions in pain and disability during a 26-week period and, in general, was well tolerated.
Source: The Journal of Foot and Ankle Surgery - Category: Orthopaedics Source Type: research
This study examines the outcomes of patients following extracorporeal shock wave therapy plus a home exercise program. This prospective case series study involves a total of 39 patients, with a mean follow-up duration of 163 (range 65 to 385) days. This has demonstrated significant benefits in pain, stiffness, and a range of measures of local and global function. Median (interquartile range [IQR]) values for average self-reported pain improved from 6.5 of 10 (IQR 5.0 to 7.8) at baseline to 3.5 of 10 (IQR 2.0 to 5.1) at 3 months and to 2.0 of 10 (IQR 0.6 to 4.8) at 6 months for patients with insertional Achilles tendinopath...
Source: The Journal of Foot and Ankle Surgery - Category: Orthopaedics Source Type: research
The objective of this prospective, double-blinded, randomized controlled trial was to compare the results in terms of improvement of a foot functional score, lower level of reported pain, and return to sports in 2 groups of contact sport athlete affected by a grade I or II lateral ankle sprain. Patients were randomized using random blocks to the NIN program (group I) or a sham device (group II). The outcome measurements were the use of a self-reported Inability Walking Scale, patient-reported subjective assessment of the level of pain using a standard visual analogue scale, and daily intake of nonsteroidal antiinflammatory...
Source: The Journal of Foot and Ankle Surgery - Category: Orthopaedics Source Type: research
ConclusionAlthough clinical gain was systematic, functional and satisfaction scores were independent of whether subtalar fusion ratio was partial or complete.Level of evidenceIV, retrospective study.
Source: Orthopaedics and Traumatology: Surgery and Research - Category: Orthopaedics Source Type: research
Publication date: Available online 22 March 2019Source: Journal of OrthopaedicsAuthor(s): Jordan D. Perchik, Ryan P. Murphy, Derek M. Kelly, Jeffrey R. SawyerAbstractDiagnostic radiographs, computed tomography (CT), nuclear medicine studies, and intraoperative fluoroscopy durations were analyzed for radiation exposure. Cumulative and yearly effective ionizing radiation doses, cumulative background radiation, and total radiograph studies were compared between pediatric and adult populations. In 24 patients with 1,246 imaging studies (average 5.5 years longitudinal treatment duration), the mean estimated cumulative effective...
Source: Journal of Orthopaedics - Category: Orthopaedics Source Type: research
More News: Bone Graft | Cardiology | Clinical Trials | Heart | Heart Transplant | Hospitals | Liver | Liver Transplant | Lung Transplant | Medical Devices | Perfusion | Study | Transplant Surgery | Transplants | Urology & Nephrology