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Medtech approvals: FDA releases August 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in August 2015: Summary of PMA Originals & Supplements Approved Originals: 2 Supplements: 70 Summary of PMA Originals Under Review Total Under Review: 57 Total Active: 28 Total On Hold: 29 Summary of PMA Supplements Under Review Total Under Review: 569 Total Active: 422 Total On Hold: 147 Summary of All PMA Submissions Originals: 5 Supplements: 90 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 70 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 229.0 FDA Time: 130...
Source: Mass Device - October 23, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Source Type: news

Minimally Invasive Access Aortic Arch Surgery
Conclusions: Minimally invasive aortic arch surgery via partial upper sternotomy does not increase the risk of morbidity or mortality. Thus, in experienced hands, it is viable, safe, and therefore favorable and as a result should be offered to more patients.
Source: Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery - September 1, 2017 Category: Cardiovascular & Thoracic Surgery Tags: Original Articles Source Type: research

Preventable Cases of Oral Anticoagulant-Induced Bleeding: Data From the Spontaneous Reporting System
Conclusion: Our findings describe the most reported risk factors for preventability of oral anticoagulant-induced bleedings. These factors may be useful for targeting interventions to improve pharmacovigilance activities in our regional territory and to reduce the burden of medication errors and inappropriate prescription. Introduction Oral anticoagulant therapy is widely used for the prevention of stroke and systemic embolism in patients with atrial fibrillation, or for the prevention and treatment of deep vein thrombosis and pulmonary embolism (Raj et al., 1994; Monaco et al., 2017). Oral anticoagulants can be di...
Source: Frontiers in Pharmacology - April 29, 2019 Category: Drugs & Pharmacology Source Type: research

Conventional Versus Minimally Invasive Aortic Valve Replacement: Pooled Analysis of Propensity‐Matched Data
ConclusionMinimally invasive aortic valve replacement can be performed safely despite the longer ischemic time. While minimally invasive surgery does demonstrate some advantages in postoperative recovery, we failed to find any other substantial improvement in outcome over conventional aortic valve replacement.
Source: Journal of Cardiac Surgery - December 22, 2014 Category: Cardiovascular & Thoracic Surgery Authors: Ju Y. Lim, Salil V. Deo, Salah E. Altarabsheh, Sung H. Jung, Patricia J. Erwin, Alan H. Markowitz, Soon J. Park Tags: Original Article Source Type: research

Embolic Strokes and Relapsing Infective Endocarditis Due to Neisseria Subflava (P1.316)
CONCLUSIONS: N.subflava can be a causative agent for relapsing infective endocarditis complicated with embolic strokes. The management of stroke in the setting of IE is different and it is important to be aware of it to avoid complications.Disclosure: Dr. Rodriguez Alvarez has nothing to disclose. Dr. Pillai has nothing to disclose. Dr. Khanna has nothing to disclose.
Source: Neurology - April 3, 2016 Category: Neurology Authors: Rodriguez Alvarez, M., Pillai, A., Khanna, R. Tags: Other Bacterial Infections Source Type: research

Iatrogenic dissection of the descending aorta: Conservative or endovascular treatment?
In this report, we refer the bibliographic data and we discuss the treatment options in these cases. PMID: 27397470 [PubMed - in process]
Source: Annals of Cardiac Anaesthesia - June 30, 2016 Category: Anesthesiology Authors: Baikoussis NG, Argiriou M, Kratimenos T, Karameri V, Dedeilias P Tags: Ann Card Anaesth Source Type: research

Medtronic wins CE Mark for Intellis SCS, PNS systems
Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for its Intellis spinal cord stimulation and peripheral nerve stimulation systems designed to treat chronic pain. The Fridley, Minn.-based company touted the Intellis as the world’s smallest fully implantable SCS neurostim. The newly-cleared system includes improved battery performance and is managed through the use of a Samsung Galaxy Tab S2 tablet. “Medtronic’s goal is to simplify treatment and improve the patient experience with personalized therapy that provides long-term pain relief and helps restore function. The launch ...
Source: Mass Device - November 6, 2017 Category: Medical Devices Authors: Fink Densford Tags: Neuromodulation/Neurostimulation Pain Management Regulatory/Compliance Medtronic Source Type: news

Ministernotomy or sternotomy in isolated aortic valve replacement? Early results.
Conclusions: Ministernotomy for AVR is a safe method and does not increase morbidity and mortality. It significantly reduces post-operative blood loss and shortens hospital stay. Ministernotomy can be successfully used as an alternative method to sternotomy. PMID: 30647743 [PubMed]
Source: Polish Journal of Cardio-Thoracic Surgery - January 17, 2019 Category: Cardiovascular & Thoracic Surgery Tags: Kardiochir Torakochirurgia Pol Source Type: research

Routine minimalist transcatheter aortic valve implantation with local anesthesia only
Conclusion Transfemoral TAVR can be safely performed with local anesthesia alone and without an on-site anesthesiologist in the vast majority of patients.
Source: Journal of Cardiovascular Medicine - September 12, 2020 Category: Cardiology Tags: Research articles: Editorial Source Type: research

How Common are Aortic Aneurysms?
Discussion Aortic root dilatation or thoracic aortic aneurysm occurs in 6:100,000 individuals > 50 years of age. It is due to aging, hypertension, hypercholesterolemia, and smoking. Tertiary syphilis was a cause in the preantibiotic era. Pediatric aneurysms are very uncommon but the exact prevalence is different due to the various causes. Aneurysms are due to genetic disorders, congenital anomalies or post-surgical repair. In pediatric patients with sudden cardiac deaths, 5.4% are due to ruptured thoracic aortic aneurysms. Learning Point Some causes of pediatric aneurysms include: Familial thoracic aneurysm and dissect...
Source: PediatricEducation.org - February 22, 2021 Category: Pediatrics Authors: Pediatric Education Tags: Uncategorized Source Type: news

Spontaneous Spinal Epidural Hematoma in an Adult Patient with Complex Congenital Heart Disease
We report the case of a 27-year-old man who developed sudden upper back pain with no specific precipitant. Five days later, he visited our emergency department complaining of weakness in both lower limbs and dysuria. He had a history of intracardiac repair and a Blalock-Park procedure for an interrupted aortic arch and ventricular septal defect in infancy. Additionally, he had undergone an aortic root dilatation and aortic valve replacement at the age of 10 because of progression of aortic and supra-aortic stenosis and had received chronic anticoagulation and antiplatelet therapy with warfarin and aspirin, respectively. An...
Source: International Heart Journal - July 8, 2021 Category: Cardiology Authors: Toshinobu Ifuku Toshihiro Nishiguchi Source Type: research

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