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FDA labels Edwards Lifesciences ’ recall of Swan Ganz thermodilution caths as Class I
The FDA has labeled a select recall of Edwards Lifesciences‘ (NYSE:EW) Swan-Ganz Thermodilution catheters over issues with the lumen assembly as Class I. Class I designations, the FDA’s most severe, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death. The Irvine, Calif.-based company’s Swan-Ganz Thermodilution catheters function as a diagnostic tool to determine hemodynamic pressures and cardiac output and are intended for use with a compatible cardiac output computer. The catheters have indications for measuring hemodynamic c...
Source: Mass Device - February 4, 2019 Category: Medical Devices Authors: Fink Densford Tags: Catheters Featured Food & Drug Administration (FDA) Recalls Vascular Edwards Lifesciences Source Type: news
Edwards wins FDA nod for next-gen HemoSphere platform
Edwards Lifesciences (NYSE:EW) said yesterday that it won FDA 510(k) clearance for its Hemosphere platform with the Acumen suite of decision-support solutions intended for hemodynamic monitoring. The Irvine, Calif.-based company touted that the newly cleared HemoSphere platform is the first to include predictive monitoring for moderate to high-risk surgical patients. The system now includes the Acumen hypotension prediction index, a machine-learning powered algorithm intended to indicate the likelihood of a hypotensive event, and the Acumen IQ sensor, which allows the HPI software to update parameters every 20 seconds, Edw...
Source: Mass Device - December 4, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Blood Management Food & Drug Administration (FDA) Regulatory/Compliance Edwards Lifesciences Source Type: news
Lauren ’s story: How roller derby saved my life
I wasn’t a particularly athletic child. The second day of soccer practice, in sixth grade, we had to run laps around the soccer field, and 10-year-old me said, “I feel like I’m going to have a heart attack!” My coach disagreed. I quit. That much running was not for me. Fifteen years later, at age 25, I had not only joined a roller derby league, but had also worked my way up to doing contact drills at practice in just three months. I felt incredible! I felt powerful! I felt unstoppable… until I went into cardiac arrest at a Thursday night practice this past July. A lost two days I woke up the ...
Source: Thrive, Children's Hospital Boston - December 6, 2017 Category: Pediatrics Authors: Lauren Simano Tags: Diseases & Conditions Our Patients’ Stories ALCAPA Boston Adult Congenital Heart Program Coronary Artery Program Dr. Luis Quinonez Source Type: news
Abbott maintains Nanostim halt on docking button issue
Abbott (NYSE:ABT) said this month that it’s maintaining the worldwide halt on implantations of the Nanostim leadless pacemaker made by its St. Jude Medical subsidiary after reports surfaced of problems with the device’s docking button. The 3.6mm docking button is designed to allow the Nanostim device to be retrieved after implantation; it’s meant to connect with the retrieval catheter during removal. In a Nov. 17 letter to physicians, Abbott said it received three reports of docking buttons detaching, out of 1,423 Nanostim implantations (0.002%), with no serious injuries reported. One of the cas...
Source: Mass Device - December 5, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Recalls Wall Street Beat Abbott Cardiac Rhythm Management stjudemedical Source Type: news
Edwards wins FDA nod for HemoSphere monitoring platform
Edwards Lifesciences (NYSE:EW) shares rose this morning after the company said it won FDA clearance for its HemoSphere advanced monitoring platform. Hemodynamic monitoring, the measurement of a patient’s blood circulation and cardiac function, enables clinicians to evaluate whether a patient is receiving enough oxygen to their organs and tissues. The Irvine, Calif.-based company’s blood monitoring device is wireless and incorporates visual clinical support screens and a touchscreen. The HemoSphere monitor is compatible with the company’s Swan-Ganz pulmonary artery catheter and Oximetry catheters...
Source: Mass Device - April 19, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Blood Management Hospital Care Patient Monitoring Regulatory/Compliance Wall Street Beat Edwards Lifesciences Source Type: news
Edwards Lifesciences wins CE Mark for HemoSphere blood flow monitor
Edwards Lifesciences (NYSE:EW) said yesterday that it won CE Mark approval in the European Union for its HemoSphere blood flow monitor. Hemodynamic monitoring, the measurement of a patient’s blood circulation and cardiac function, enables clinicians to evaluate whether a patient is receiving enough oxygen to their organs and tissues. The device includes visual clinical support screens and is compatible with the Edwards Swan-Ganz pulmonary artery catheter and Oximetry catheters. “The HemoSphere advanced monitor enables simplified visual clinical support, which is particularly important in the care of our mo...
Source: Mass Device - January 18, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Blood Management Hospital Care Regulatory/Clearance Wall Street Beat Edwards Lifesciences Source Type: news
The heart and the head: Meeting milestones after pediatric heart surgery
When their unborn son Silas was diagnosed with congenital heart disease at 22 weeks gestation, Montana and Michael Green knew he faced a long road. Though their primary concern was Silas’ health they also worried their son might face developmental delays, a common side effect following infant heart surgery. Silas was diagnosed with double-outlet right ventricle (DORV) , a complicated abnormality in which the pulmonary artery and the aorta — the heart’s two great arteries — both arise from the right ventricle. This disrupts the flow of oxygenated blood throughout the body. DORV is often associat...
Source: Thrive, Children's Hospital Boston - August 2, 2016 Category: Pediatrics Authors: Erin Horan Tags: Our Patients’ Stories Cardiac Neurodevelopmental Program congenital heart disease DORV Heart Center Samantha Butler PhD Source Type: news
Take the challenge: Answer this USMLE Step 1 question
When it comes to taking exams, not all questions are created equal. If you’re preparing for the United States Medical Licensing Examination® (USMLE®) Step 1 exam, you need this exclusive scoop on one of the most commonly missed USMLE test prep questions. Find out what this month’s challenging question is, and view an expert video explanation of the answer from Kaplan Medical. Welcome to this month’s installment of the AMA Wire® series, Tutor talk: Tips from Kaplan Medical on the most missed USMLE test prep questions from Kaplan’s Qbank: Step 1. Each month, we’re revealin...
Source: AMA Wire - June 27, 2016 Category: Journals (General) Authors: Amy Farouk Source Type: news
FDA releases May 2016 510(k) clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD May 2016 TOTAL 510(k)s THIS PERIOD 213 TOTAL WITH SUMMARIES 205 TOTAL WITH STATEMENTS 8 May 2016 510(k) Clearances SHARE TWEET LINKEDIN PIN IT EMAIL PRINT 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD May 2016 DEVICE: O-PEP PARI RESPIRATORY EQUIPMENT, INC. 510(k) NO: K150044(Traditional) ATTN: Michael Judge PHONE NO : 1 804 2537274 2412 PARI Way SE DECISION MADE: 27-MAY-16 Midlothian VA 23112 510(k) SUMMARY AVAILABLE FROM FDA ...
Source: Mass Device - June 8, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
MassDevice.com +5 | The top 5 medtech stories for June 6, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters. 5. Axonics wins CE Mark for SNM, touts cost-efficacy study Axonics Modulation Technologies said today it won CE Mark approval in the European Union for its SNM sacral nerve modulation system and announced the publication of a cost...
Source: Mass Device - June 6, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
ESC adds St. Jude’s CardioMems to guidelines for directed HF therapy
The European Society of Cardiology has added St. Jude Medical‘s (NYSE:STJ) CardioMems heart failure system to its guidelines as a “directed therapy management and monitoring tool for heart failure patients,” the company said today. The CardioMems device consists of a wireless sensor implanted in the pulmonary artery via catheter to directly measure pressure in the vessel. The device is designed to help physicians manage patients’ medication to control their heart failure before visible changes to weight or blood pressure occur. The new guidelines, published this year, support the use of pulmona...
Source: Mass Device - June 6, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular St. Jude Medical Source Type: news
Pulmonary Artery Catheterization on the Rise (CME/CE)
(MedPage Today) -- Uptick likely due to changing hospital patient population, not inappropriate use (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - December 3, 2015 Category: Cardiology Source Type: news
Study: St. Jude’s CardioMEMS might not be cost-effective
St. Jude Medical (NYSE:STJ)’s CardioMEMS may not be a cost-effective solution for patients with congestive heart failure, according to a study from the non-profit Institute for Clinical and Economic Review in Boston. The group analyzed the cost effectiveness of St. Jude’s device, which consists of a wireless sensor implanted in the pulmonary artery via catheter to directly measure pressure in the vessel. The device is designed to help physicians manage patients’ medication to control their heart failure before visible changes to weight or blood pressure occur. In the report, the ICER suggests th...
Source: Mass Device - September 11, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Institute for Clinical and Economic Review (ICER) St. Jude Medical Source Type: news
How To Mend A Broken Heart
(Photo: © Kyle Bean) The need to mend broken hearts has never been greater. But what if we could simply manufacture a new one? Alex O’Brien studies the legacy of Texan surgeons and artificial hearts.Haskell Karp was 37 when he suffered his first heart attack, and over the next ten years he suffered a variety of related problems. By 1969 even the slightest effort, like combing his hair or brushing his teeth, would bring on chest pain or extreme shortness of breath. There are four grades of heart failure under the classification determined in 1928 by the New York Heart Association; Karp’s was classified a...
Source: Science - The Huffington Post - June 8, 2015 Category: Science Source Type: news
Joey’s message of hope: Listen to your heart
Five minutes. That’s how long Joey Williams was expected to live – IF he made it to term, which his doctors were not expecting. His mother, Rebecca Williams, received the prognosis when she was 21 weeks pregnant. Prenatal testing had already revealed that Joey had Down syndrome and a significant type of congenital heart disease in which one of the sides of his heart was underdeveloped. His diagnoses included atrial septal defect and ventricular septal defect. When Rebecca heard the news of her son’s meager life expectancy, she was devastated. Yet she also felt a well of unconditional love grow ...
Source: Thrive, Children's Hospital Boston - February 9, 2015 Category: Pediatrics Authors: Erin Horan Tags: Heart conditions Our patients’ stories Source Type: news
This year's top 10 advances in cardiovascular disease
Progress in the fight against heart disease and stroke came on many fronts during 2014, from novel drugs and procedures to improvements and newfound benefits from existing treatments. In the December 2014 Harvard Heart Letter, Editor in Chief Dr. Deepak L. Bhatt selected 10 of the most important advances. New drugs cut cholesterol levels by half. A new class of drugs, given by injection just once or twice a month, can slash harmful LDL cholesterol levels by about 50%. Studies are under way to see if any of these experimental agents, called PCSK9 inhibitors, prevent heart attacks or improve heart disease survival. Replacing...
Source: New Harvard Health Information - November 24, 2014 Category: Consumer Health News Source Type: news
Edwards ClearSight Non-Invasive Hemodynamic Monitoring System Released in U.S. (VIDEO)
Continuous hemodynamic monitoring, such as stroke volume and cardiac output, is normally performed using a pulmonary artery catheter. Yet, the very patients that are fragile enough to require such monitoring are often not the best candidates to handle such invasive devices. This has led to difficult choices having to be made on how to manage weak post-surgical patients who can benefit from blood volume and flow monitoring. A new system from Edwards Lifesciences, just been cleared by the FDA, now offers advanced hemodynamic information, comparable to that provided by minimally invasive catheters, using only a...
Source: Medgadget Anesthesiology - July 3, 2014 Category: Anesthesiology Authors: Editors Tags: Anesthesiology Cardiac Surgery Cardiology Critical Care Medicine Source Type: news
FDA Approves Novel Implanted Sensor To Monitor Heart Failure
The FDA announced today that it had approved the CardioMEMS Champion HF System. The small implantable device provides daily pulmonary artery pressure measurements to guide physicians in their treatment of NYHA Class III heart failure patients who have been hospitalized for heart failure in the previous year. The system consists of three parts: a small permanent sensor implanted in the pulmonary artery, a catheter-based delivery system, and a system that acquires and processes PA pressure measurements from the implanted monitor and transfers the data to a secure database. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - May 28, 2014 Category: Pharmaceuticals Authors: Larry Husten Source Type: news