Another Breakthrough Designation for Concept Medical

Concept Medical’s MagicTouch AVF might have the “magic touch” when it comes down to nabbing breakthrough device designations. The proposed indication for the latest breakthrough device designation is for the treatment of stenotic lesions of Arteriovenous Fistulae or Arteriovenous graft in the hemodialysis treatment of renal failure. Concept Medical said its first pilot study to investigate the safety and efficacy of Magic Touch PTA Sirolimus balloon was started in Singapore in 2018. Led by Principal Investigator, Dr. Tan Chieh Suai, a multi-disciplinary team of doctors consisting of interventional nephrologists, vascular surgeons and interventional radiologists, is conducting the study entitled “Sirolimus coated angioplasty balloon in the salvage of thrombosed arteriovenous graft” in Singapore General Hospital. Suai is also Senior Consultant and Director for the Interventional Nephrology Program in the Department of Renal Medicine in Singapore General Hospital and Duke-NUS Medical School. “The award of the breakthrough Device Designation for the use of sirolimus coated balloons in dialysis access is fantastic news for patients on hemodialysis, as there is an urgent need for effective and durable treatment for narrowing (stenosis) within the dialysis circuit,” Suai said in a release. “We are very encouraged by the early results of our ...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Source Type: news

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AbstractPurposeTo investigate risk factors for severe bleeding during warfarin treatment, including the influence of sex, age, comorbidity and co-medication on bleeding risk.MethodsPatients initiating warfarin treatment between 2007 and 2011 were identified in the nationwide Swedish Prescribed Drug Register, and diagnoses of severe bleeding were retrieved from the National Patient Register. Hazard ratios (HR) with 95% confidence intervals (CI) for severe bleeding were estimated using multiple Cox regression adjusting for indications and including covariates age, sex, comorbidities and co-medications. Interactions between s...
Source: European Journal of Clinical Pharmacology - Category: Drugs & Pharmacology Source Type: research
Diabetes mellitus (DM) is a globally chronic condition that currently affects over 422 million people worldwide, a number that has been estimated to grow to 552 million by 2030 [1,2]. Saudi Arabia is one of the nations with the highest DM prevalence regionally and internationally [3]. Hypertension (HT) is more common in patients with diabetes than in those without diabetes [4,5]. The co-occurrence of HT has a substantial clinical effect of producing a poor outcome for patients with diabetes. Complications such as renal failure, stroke, heart disease, peripheral vascular disease, and mortality are the most adverse outcomes ...
Source: Primary Care Diabetes - Category: Primary Care Authors: Tags: Original research Source Type: research
AbstractPurpose of ReviewThe main objective in this 2nd part is to highlight comorbidities of great clinical importance such as diabetes, anemia, and chronic renal failure, either because of their high prevalence, or because of their relevance to impact on morbidity and mortality, and directly in the treatment of heart failure.Recent FindingsThe prevalence of heart failure will increase 46% from 2012 to 2030, resulting in>  8 million people ≥ 18 years of age. This disease have a large burden of noncardiovascular comorbidities, which may increase the risk of mortality and decrease quality of life. T...
Source: Current Emergency and Hospital Medicine Reports - Category: Emergency Medicine Source Type: research
This study highlighted sex differences in areas that could account for the underuse of the procedure in both sexes, with women affected to a greater extent. Understanding these factors will help address the unmet needs of both sexes after TJA by encouraging future studies and provider education to ensure that all patients are able to access the necessary procedures for pain relief and functional improvement. PMID: 32015251 [PubMed - as supplied by publisher]
Source: The Journal of the American Academy of Orthopaedic Surgeons - Category: Orthopaedics Tags: J Am Acad Orthop Surg Source Type: research
Authors: Lin WC, Tsai JP, Lai YH, Lin YL, Kuo CH, Wang CH, Hsu BG Abstract Osteoprotegerin (OPG) is a potential biomarker of cardiovascular disease complications and severity. Peripheral arterial disease (PAD) is associated with an increased risk of death in patients on peritoneal dialysis (PD). Therefore, this study aimed to evaluate the relationship between serum OPG levels and PAD by measuring the ankle-brachial index (ABI) of patients on PD. A commercial enzyme-linked immunosorbent assay kit was used to measure OPG values. Left or right ABI values of
Source: Renal Failure - Category: Urology & Nephrology Tags: Ren Fail Source Type: research
CONCLUSION: Multiple complications after surgery for lower limb PAD carried a compounding risk of reduced long term amputation free survival. Patients experiencing at least one complication form a high risk group that requires increased attention to prevent the potential development of further complications. PMID: 31879146 [PubMed - as supplied by publisher]
Source: PubMed: Eur J Vasc Endovasc ... - Category: Surgery Authors: Tags: Eur J Vasc Endovasc Surg Source Type: research
Abstract Objective: To evaluate the prognostic value of CHA2DS2-VASc score in individuals undergoing isolated coronary artery bypass grafting (CABG) surgery. Methods: Records of consecutive 464 patients who underwent elective isolated CABG, between January 2015 and August 2017, were retrospectively reviewed. A major adverse cardiac event (MACE) was the primary outcome of this study. MACE in patients with low (L) ( 2 had 52.6% sensitivity and 84.1% specificity (AUC: 0.752, P
Source: Revista Brasileira de Cirurgia Cardiovascular - Category: Cardiovascular & Thoracic Surgery Source Type: research
The regulatory pathway for Shockwave Medical’s Intravascular Lithotripsy (IVL) technology just received a huge jolt from FDA. The agency granted the Santa Clara, CA-based company breakthrough device designation for the Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter. The firm’s device is designed to fracture problematic calcium using sonic pressure to facilitate stent delivery, deployment, and optimal expansion, thereby improving blood flow to the heart muscle. Shockwave’s technology is being evaluated in the DISRUPT CAD III, a prospective, non-randomiz...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Cardiovascular Source Type: news
CONCLUSION: In this study, we could not detect an advantage in survival when SAVR or TAVR were utilized in intermediate to high surgical risk patients needing aortic valve replacement for severe aortic stenosis. PMID: 31596707 [PubMed - in process]
Source: The Heart Surgery Forum - Category: Cardiovascular & Thoracic Surgery Authors: Tags: Heart Surg Forum Source Type: research
Authors: Wang TKM, Liao YB, Choi D, Harmos S, Haydcok D, Gerber I Abstract AIMS: A significant minority of patients undergoing mitral valve surgery (MVR) have indication for coronary artery bypass grafting (CABG). The risks of combination surgeries are not well appreciated and maybe more than additive. We compared the characteristics and outcomes of MVR+/-CABG performed at our centre. METHODS: Consecutive patients undergoing isolated MVR or with concurrent (MVR+)CABG at Auckland City Hospital during 2005-2012 were compared for baseline and operative characteristics and outcomes in univariable and multivariable ...
Source: New Zealand Medical Journal - Category: General Medicine Tags: N Z Med J Source Type: research
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