MedAlliance Gains CE Mark Approval for Coronary SELUTION SLR(TM) Sirolimus Drug Eluting Balloon
NYON, Switzerland, June 30, 2020 -- (Healthcare Sales & Marketing Network) -- MedAlliance has announced the award of its second CE Mark: SELUTION SLR 014 PTCA, a novel Sirolimus Drug Eluting Balloon (DEB), for the treatment of coronary arterial disease. ... Devices, Interventional, Cardiology, Regulatory MedAlliance, SELUTION SLR, Sirolimus, Drug Eluting Balloon (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - June 30, 2020 Category: Pharmaceuticals Source Type: news
New Research Finds Abbott's Optical Coherence Tomography Imaging Changed Treatment Decisions in 88% of Artery Blockages
-- Using optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI), physicians were able to select the right size stents and place them with greater precision (Source: Abbott.com)
Source: Abbott.com - June 26, 2020 Category: Pharmaceuticals Source Type: news
ABRE Study Meets Primary Safety and Effectiveness Endpoints
Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced the first-ever results from the ABRE clinical study assessing the safety and effectiveness of the investigational Abre ™ venous self-expanding stent system in subjects with iliofemoral venous outflow obstruction. The study met the primary safety and effectiveness endpoints, and the data were presented today virtually via the 2020 Charing Cross Symposium. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - June 17, 2020 Category: Cardiology Source Type: news
Medtronic Expands Indications for the Resolute Onyx DES in Europe
Medtronic has scored CE mark for a unique indication for the Resolute Onyx drug-eluting stent. The Dublin-based company said the approval was for a DAPT indication for high bleeding risk (HBR) patients.
The firm said for HBR patients whose bleeding risk may be increased by taking longer DAPT regimens (a combination of aspirin and anti-clotting medication), this new, indication allows physicians to recommend a shorter, one-month regimen of DAPT, following a percutaneous coronary intervention (PCI) with Resolute Onyx.
The indication is based on results from the Onyx ONE Global Study, a prospective, randomized, one-month DAPT...
Source: MDDI - June 8, 2020 Category: Medical Devices Authors: MDDI Staff Tags: Regulatory and Compliance Cardiovascular Source Type: news
Abiomed Granted IDE to Evaluate ‘World’s Smallest Heart Pump’
Abiomed said it has received approval for an IDE to start an early feasibility study of what it is calling the “world’s smallest heart pump.â€
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The Danvers, MA-based company said the first-in-human trial will look at the 9 French Impella ECP heart pump in high-risk percutaneous coronary intervention (PCI) patients.
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The primary endpoint of the study is successful delivery, initiation, and maintenance of adequate hemodynamic support and a composite rate of major device-related adverse events during high-risk PCI.
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The stu...
Source: MDDI - June 6, 2020 Category: Medical Devices Tags: Cardiovascular Regulatory and Compliance Source Type: news
FDA Clears Innovative Angioplasty Scoring and Cutting Platform
New metal-alloy sheath converts angioplasty balloons into scoring and cutting systems
PARK CITY, Utah, June 4, 2020 -- (Healthcare Sales & Marketing Network) -- Transit Scientific announced the FDA cleared the XO Score® Percutaneous Transluminal An... Devices, Interventional, FDA Transit Scientific, XO Score, Scoring Sheath, Angioplasty (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - June 4, 2020 Category: Pharmaceuticals Source Type: news
Two paths better than one for treating patients with heart stents
(University of Alberta Faculty of Medicine& Dentistry) Pairing a blood-thinning drug with aspirin daily for patients who have an angioplasty with a stent can contribute to better health outcomes, including lower risk of death, than aspirin alone, according to a recent study by cardiologists at the University of Alberta and Mazankowski Alberta Heart Institute. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - May 28, 2020 Category: International Medicine & Public Health Source Type: news
Primary PCI Remains Standard of Care for STEMI During COVID-19
WEDNESDAY, April 29, 2020 -- Primary percutaneous coronary intervention (PCI) remains the standard of care for patients with ST-elevation myocardial infarction (STEMI) during the COVID-19 pandemic, according to a consensus statement published online... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 29, 2020 Category: Pharmaceuticals Source Type: news
COVID-19 Business Updates Provide Some Clarity
The unknowns still outnumber the knowns, but recent business updates provide some clarity around how the medical device industry is fairing during the COVID-19 pandemic. First and foremost, it is clear that companies are hurting in the areas of elective procedures, which are being deferred. But there may be some silver linings hidden amongst the bad news.
Needham & Co. medtech analyst Mike Matson estimates that medical device sales across the industry will continue to drop by an average of 40% to 50% until the economy begins to reopen and hospitals start to resume elective procedures.
Matson's e...
Source: MDDI - April 10, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 Business Source Type: news
Cardiac Arrest Deaths at Home in New York City
Have Increased By a Startling 800%
There's been a 50% or more drop in the number of people receiving emergency treatment for heart attacks in many hospitals. Physicians have been speculating why this might be. Now frightening numbers from New York City's overwhelmed emergency medical system may provide part of the answer: hundreds of people a day have been dying of cardiac arrest in their homes, an eight-fold increase over the same period last year. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - April 8, 2020 Category: Cardiology Source Type: news
CABG Tied to Lower Death Rate in MI Complicated by Cardiogenic Shock CABG Tied to Lower Death Rate in MI Complicated by Cardiogenic Shock
Coronary-artery-bypass grafting (CABG) is associated with lower in-hospital mortality in myocardial infarction (MI) complicated by cardiogenic shock, compared with percutaneous coronary intervention (PCI), according to a database study.Reuters Health Information (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - April 7, 2020 Category: Surgery Tags: Cardiology News Source Type: news
Doctors Say: Don't Sit Out a Heart Attack at Home
Since the onset of the novel coronavirus COVID-19, hospital emergency departments have seen a precipitous drop in the number of heart attack patients presenting for treatment. The big question is why? Are there really less heart attacks occurring, or are patients staying home, afraid to come to the hospital for fear of contracting the virus? There's good reason to believe that the latter may be the case, and the implications are extremely troubling. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - April 7, 2020 Category: Cardiology Source Type: news
Shockwave Completes Enrollment in Pivotal Study for Coronary Intravascular Lithotripsy
Shockwave Medical, Inc. (NASDAQ: SWAV) announced today that the company has completed enrollment in the pivotal U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study – DISRUPT CAD III – for the use of IVL in heavily calcified coronary arteries. The investigational Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter, which has been granted Breakthrough Device Designation by the FDA, is an innovative therapy designed to fracture problematic calciu m using sonic pressure waves in order to facilitate stent delivery, deployment and optimal expansion. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - April 6, 2020 Category: Cardiology Source Type: news
TWILIGHT Benefits of Dropping Aspirin Hold Up in Diabetes TWILIGHT Benefits of Dropping Aspirin Hold Up in Diabetes
Treatment with ticagrelor alone shows no increase in bleeding, MI, or stroke after percutaneous coronary intervention in the TWILIGHT trial subanalysis.Medscape Medical News (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - April 1, 2020 Category: Cardiology Tags: Cardiology News Source Type: news
Genetic testing for antiplatelet therapy post-PCI misses cut in cardiovascular events
(American College of Cardiology) An international clinical trial that used genetic testing to guide which antiplatelet medication was given to patients following percutaneous coronary intervention (PCI) did not meet its stated goal for cutting in half the incidence of serious adverse cardiovascular events, such as heart attack and stroke, in the year following the procedure, according to study results presented at the American College of Cardiology's Annual Scientific Session Together with World Congress of Cardiology (ACC.20/WCC). (Source: EurekAlert! - Biology)
Source: EurekAlert! - Biology - March 30, 2020 Category: Biology Source Type: news
