CorMatrix wins FDA nod for Tyke neonate cardiac tissue

CorMatrix Cardiovascular said today it won FDA 510(k) clearance for its Tyke biomaterial for use in neonates and infants. The patch is designed to repair pericardial structures and as an epicardial covering or for intracardiac defects, septal defects, annulus repair, suture-line buttressing. The Tyke is derived from the company’s ECM technology platform and is composed of 2 layers of ECM, as opposed to 4 layers in their standard cardiac tissue repair patches, making it thinner for smaller repairs. “FDA clearance further validates CorMatrix ECM technology for creating world class implantable cardiac devices. CorMatrix is proud of this clearance achievement and the potential impact it can have on reducing CHD in children. This is but one small step in our ongoing quest to develop and deliver ideal materials for use in reconstructing damaged cardiac and vascular tissues. Tyke and other CorMatrix cardiac products will help us extend and improve the lives of those who receive our implants and move toward a global goal of making cardiovascular disease curable,” CEO David Camp said in a press release. The Tyke was developed as an alternative to synthetic grafts and patches to improve the repairing of complex reocnstructive surgeries in young patients with congenital heart defects such as atrial-septal defects and small pulmonary vessels, the company said. “The Tyke product was developed in response to congenital surgeon’s directed needs. It is our state...
Source: Mass Device - Category: Medical Equipment Authors: Tags: 510(k) Cardiovascular Food & Drug Administration (FDA) Regenerative Medicine Regulatory/Clearance CorMatrix Cardiovascular Inc. Source Type: news

Related Links:

Conclusions: The study ’s findings support the efficacy of tube weaning based on the published “Graz model of tube weaning” for children born with EA/TEF and indicate the necessity of specialized tube weaning programs for these patients.What is Known:• Children with esophageal atresia/tracheoesophageal fistula often suffer from feeding problems and tube dependency.• Different tube weaning programs and outcomes have been published, but not specifically for children with EA.What is New:• Evaluation of a large sample of children referred for tube weaning after EA repair.• Most children wi...
Source: European Journal of Pediatrics - Category: Pediatrics Source Type: research
Publication date: December 2020Source: Journal of Functional Foods, Volume 75Author(s): Jian Zhang, Xiaohang Fu, Wenhui Li, He Li, Zhiwei Ying, Xinqi Liu, Liduan Yin
Source: Journal of Functional Foods - Category: Nutrition Source Type: research
Authors: Ebrahimi-Zadehlou P, Najafpour A, Mohammadi R Abstract PURPOSE: It is compulsory to make a tension-free, end-to-end repair in transected injuries. However, when it comes to longer defects, placement of an autograft or nerve conduits is required. The present study was designed to assess regenerative potential of silymarin nanoparticles loaded into chitosan conduit on peripheral nerve regeneration in a transected sciatic nerve model in rat. METHODS: In NML group left sciatic nerve was exposed through a gluteal muscle incision and after careful hemostasis skin was closed. In TSC group left sciatic nerve w...
Source: Neurological Research - Category: Neurology Tags: Neurol Res Source Type: research
AbstractBackgroundTo repair a blow-out fracture, the endonasal approach is indicated when the center of the fracture occurs in the orbital floor medial to the infraorbital nerve, or when the orbital tissue is herniated inwards; additionally, the combined endonasal and transmaxillary approach is indicated for fractures of the anterior and lateral parts of the orbital floor.Method and conclusionThe use of endoscopic modified medial maxillectomy and special instruments enabled the surgeon to repair an outwardly herniated blow-out fracture by the endonasal approach alone, despite the center of the fracture being in the orbital...
Source: European Archives of Oto-Rhino-Laryngology - Category: ENT & OMF Source Type: research
Authors: Saito Y, Erik E L, Raval A, Gimelli G, Kurt M J, Osaki S Abstract Objective Aortic stenosis (AS) is common among elderly patients. Since transcatheter aortic valve replacement (TAVR) is a less invasive procedure than surgical aortic valve replacement for symptomatic severe AS, super-elderly patients have tended to undergo TAVR. We retrospectively investigated the post-TAVR outcome in super-elderly patients with severe AS. Methods This analysis included 433 patients who underwent TAVR in the University of Wisconsin Hospital and Clinics from 2012 to 2017. Post-TAVR mortality, complications in-hospital, rehos...
Source: Internal Medicine - Category: Internal Medicine Tags: Intern Med Source Type: research
Authors: Gualtieri B, Marzano AV, Grando S Abstract In this review, we recap current knowledge about non-desmoglein autoantigens in atypical forms of autoimmune pemphigus. More than 50 keratinocyte proteins, including adhesion molecules, receptors and enzymes as well as mitochondrial proteins can be targeted, leading to alterations in numerous intracellular signaling pathways. Patients with pemphigus herpetiformis feature various combinations of antibodies to desmogleins 1 and 3 and desmocollins 1-3. Pemphigus vulgaris patients who do not have antibodies to desmogleins develop typical clinical and histological feat...
Source: Giornale Italiano di Dermatologia e Venereologia - Category: Dermatology Tags: G Ital Dermatol Venereol Source Type: research
Background: Approximately 5.7 million people in the United States are diagnosed and living with heart failure (HF), with projected prevalence rates to increase 46% by 2030. Heart failure leads hospital admissions in the United States for individuals 65 years or older, with many acute exacerbation admissions resulting from a lack of medication management, poor patient treatment plan adherence, and lack of appropriate follow-up within the health care system. In 2017, the 30-day HF readmission rate at the facility of implementation was 27%, 3% higher than the national average and, more specifically, 18.5% for the cardiac ca...
Source: Professional Case Management - Category: Health Management Tags: Articles Source Type: research
Purpose/Objectives: The purpose of this quality improvement project was to evaluate the impact of a nurse discharge navigator on reducing 30-day readmissions for the heart failure and sepsis populations. Primary Practice Setting: The 238-bed community hospital in central Virginia is part of a health care system that encompasses 13 acute care facilities. Methodology and Sample: The aim of this project was to identify, implement, and evaluate the transition of care of high-risk readmission patients from January 2019 to April 2019. Inclusion criteria included patients who were 55 years and older, English speaking, dia...
Source: Professional Case Management - Category: Health Management Tags: Articles Source Type: research
Publication date: Available online 8 October 2020Source: Heart &LungAuthor(s): Therese Crowley Prentice, Robin Lawson
Source: Heart and Lung: The Journal of Acute and Critical Care - Category: Respiratory Medicine Source Type: research
Authors: Erbel R Abstract The progress in cardiology during the last 50 years can best be studied by looking at the diagnostics and treatment of patients with aortic valve stenosis. Previously, the clinical examination, electrocardiography (ECG) and chest X‑ray were used before heart catheterization, which included a transseptal puncture to complete the indications for surgery in young patients. Nowadays, echocardiography, often combined with a dobutamine stress test, is the primary diagnostic tool to which computed tomography for quantification of valve calcification and cardiac magnetic resonance...
Source: Herz - Category: Cardiology Tags: Herz Source Type: research
More News: Atrial Septal Defect | Cardiology | Cardiovascular | Children | Clinical Trials | Congestive Heart Failure | Gastroschisis Repair | Heart | Heart Failure | Heart Valve Disease | Heart Valve Surgery | Heart Valves | Hole in the Heart | Hospitals | Medical Devices | Pediatrics | Study