FDA clears moldable OssiMend bioactive bone graft from Collagen Matrix

Collagen Matrix said today that it won FDA 510(k) clearance for its line of OssiMend Bioactive Moldable bone graft matrix products, intended for use in spinal procedures. The Oakland, N.J.-based company said that the newly cleared OssiMend product is composed of anorganic carbonate apatite bone mineral, 45S5 bioactive glass and highly purified Type I collagen, and that it can be molded into putty for filling irregular defect sites. The moldable Ossimend product is designed to be slowly resorbed and replaced by new bone tissue, and comes in various sizes, Collagen Matrix said. “We continue to expand our product portfolio for the Spine market with the development of this unique line of Bioactive bone graft matrices that combines a carefully-selected ratio of three powerful components. This innovative moldable version offers surgeons options for better ensuring predictable outcomes,” CEO Bart Doedens said in a press release.
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Spinal collagenmatrix Source Type: news

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Conclusions: Assessment of flavin, a marker of mitochondrial complex I injury, in the perfusate provides a fast prediction of liver graft function and loss during ex situ MP before implantation. This finding may have high clinical relevance, as liver grafts from extended DBD or DCD donors carry considerable risks for recipients. On-line estimation of outcome before implantation would therefore substantially increase safe utilization of liver grafts.
Source: Annals of Surgery - Category: Surgery Tags: ESA PAPERS Source Type: research
Condition:   Burns Interventions:   Other: Early Mobilization;   Other: Late Mobilization Sponsor:   Sunnybrook Health Sciences Centre Recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Publication date: Available online 16 October 2019Source: Pharmacological ResearchAuthor(s): Sivakkanan Loganathan, Yuxing Guo, Weipeng Jiang, Tamás Radovits, Mihály Ruppert, Alex Ali Sayour, Maik Brune, Paige Brlecic, Phillipp Gude, Adrian-Iustin Georgevici, Benito Yard, Matthias Karck, Sevil Korkmaz-Icöz, Gábor SzabóAbstractThe major source of heart transplantation comes from brain-dead (BD) donors. However, brain death and myocardial ischemia/reperfusion injury during transplantation may lead to cardiac dysfunction and hemodynamic instability. A previous work demonstrated that pre-treatm...
Source: Pharmacological Research - Category: Drugs & Pharmacology Source Type: research
Abstract BACKGROUND: In a small proportion of cases, hematopoietic function is insufficient after allogeneic hematopoietic stem cell transplantation, as a result of poor graft function or graft failure. These complications are common indications of re-mobilization of the initial donor, either for a second allograft or for an infusion of CD34+ Selected stem Cell Boost (SCB). METHODS AND MATERIALS: We retrospectively reviewed the results of two cycles of CD34+ cell mobilization and collection. CD34+ cells mobilized and collected at each cycle were compared. When CD34+ cell selection from the collected allogenei...
Source: Transfusion - Category: Hematology Authors: Tags: Transfusion Source Type: research
In this study, the widely used biomaterial titanium was functionalized with BMAP27(1-18), an α-helical cathelicidin antimicrobial peptide that retains potent staphylocidal activity when immobilized on agarose beads. A derivative bearing a short spacer with a free thiol at the N-terminus was coupled to silanized titanium disks via thiol-maleimide chemistry. Tethering was successful, as assessed by Contact angle, Quartz Crystal Microbalance with Dissipation monitoring (QCM-D), and X-ray Photoelectron Spectroscopy (XPS), with an average surface mass density of 456 ng/cm2 and a layer thickness of 3 nm. The ...
Source: Colloids and Surfaces B: Biointerfaces - Category: Biochemistry Source Type: research
In this study, AT1-AAs were detected in the sera of patients with peripheral arterial disease (PAD) and the positive rate was 44.44% vs. 17.46% in non-PAD volunteers. In addition, analysis showed that AT1-AAs level was positively correlated with PAD. To reveal the causal relationship between AT1-AAs and vascular aging, an AT1-AAs-positive rat model was established by active immunization. The carotid pulse wave velocity was higher, and the aortic endothelium-dependent vasodilatation was attenuated significantly in the immunized rats. Morphological staining showed thickening of the aortic wall. Histological examination showe...
Source: Fight Aging! - Category: Research Authors: Tags: Medicine, Biotech, Research Source Type: blogs
Medication non-adherence is a risk factor for acute kidney transplant rejection. The association of non-adherence with short-term allograft loss in patients who develop acute rejection and are subsequently tre...
Source: BMC Nephrology - Category: Urology & Nephrology Authors: Tags: Research article Source Type: research
Surgical strategies for scaphoid nonunions become more complex based on time from injury to treatment. The decision-making process can follow a logical sequence. Scaphoid nonunions less than 1  year after trauma and no carpal malalignment can be treated with percutaneous screw fixation under fluoroscopic and/or arthroscopic guidance. Reinterventions or patients with avascular proximal poles that do not need substantial grafts are reliably treated with pedicle vascularized bone grafts. Re section of the distal pole of the scaphoid is a good option in old injuries or after a failed scaphoid procedure. When there is radi...
Source: Orthopedic Clinics of North America - Category: Orthopaedics Authors: Source Type: research
This study introduces a novel technique for supra-inguinal arterial reconstructions with cryopreserved femoral vein and caval allografts with a low re-infection rate and an acceptable graft re-intervention rate on early mid term analysis.
Source: European Journal of Vascular and Endovascular Surgery - Category: Surgery Authors: Source Type: research
AbstractPurposeBone tunnel widening following anterior cruciate ligament reconstruction (ACLR) is well documented, although the aetiology and clinical significance of this phenomenon remain unclear. At mid-term follow-up, a greater prevalence of tunnel enlargement has been reported with the use of hamstring (HS) grafts. However, there are paucity of data on what happens in the longer term. The aim of this study was to assess the change in femoral and tibial tunnel dimensions 15  years after four-strand HS ACLR.MethodsThis is a retrospective review of 15 patients who underwent arthroscopic ACLR using HS autograft tendo...
Source: Knee Surgery, Sports Traumatology, Arthroscopy - Category: Orthopaedics Source Type: research
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