Abiomed shares down despite Street-beating FY2019 Q1, Indian Impella approval
Shares in Abiomed (NSDQ:ABMD) have fallen today despite the medical device maker posting earnings that beat expectations by Wall Street for its fiscal year 2019 first quarter and announcing approval of its Impella heart pump in India.
The Danvers, Mass.-based company posted profits of $90.1 million, or $1.95 per share, on sales of $180 million for the three months ended June 30, seeing profits grow 141% while sales grew 35.9% compared with the same period during the previous year.
Earnings per share were well ahead of the 82¢ consensus on Wall Street, where analysts expected to see sales of $173.2 million, which the com...
Source: Mass Device - July 26, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Assist Devices Cardiovascular MassDevice Earnings Roundup Regulatory/Compliance Wall Street Beat Abiomed Source Type: news
Study: Epinephrine Not Best Choice for Cardiogenic Shock in MI
(MedPage Today) -- Higher rates of refractory shock than with norepinephrine (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - July 3, 2018 Category: Cardiology Source Type: news
Study: Epinephrine May Not Be Best Choice for Cardiogenic Shock in MI
(MedPage Today) -- Associated with higher rates of refractory shock than with norepinephrine (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - July 3, 2018 Category: Cardiology Source Type: news
Abiomed Earns FDA Approval for Adding Optical Sensor to Impella CP Heart Pump
Abiomed, which had a busy 2017 and was among our Company of the Year finalists, reported today that it has received FDA premarket approval (PMA) for its Impella CP heart pump with SmartAssist, utilizing an optical sensor. The sensor is one component of the SmartAssist technology, which also includes a software update enabling informational displays of left ventricular pressure (LVP), end-diastolic pressure (EDP), and cardiac power output (CPO) data on the Impella Console, an Abiomed spokesperson told MD+DI.
The Impella CP heart pump had already earned FDA approval for treating patients in cardiogenic shock as well as patie...
Source: MDDI - April 2, 2018 Category: Medical Devices Authors: Daphne Allen Tags: Cardiovascular Source Type: news
Abiomed wins expanded Impella FDA nod for elective, urgent high-risk PCI
Abiomed (NSDQ:ABMD) said today it won expanded FDA premarket approval for its Impella 2.5 and Impella CP heart pumps, now cleared for use during elective and urgent high risk percutaneous coronary intervention procedures.
With the expansion, the Impella heart pump is cleared for use with patients with severe coronary artery disease, complex anatomy and a number of co-morbidities with or without depressed ejection fractions, the Danvers, Mass.-based company said.
“This expanded FDA approval with moderately reduced ejection fraction validates our real-world experience using hemodynamic support in patients turned down ...
Source: Mass Device - February 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiovascular Catheters Food & Drug Administration (FDA) Regulatory/Compliance Abiomed Source Type: news
Abiomed Receives Approval for Expanded FDA Indication for Cardiomyopathy with Cardiogenic Shock
DANVERS, Mass., Feb. 13, 2018 -- (Healthcare Sales & Marketing Network) -- Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support and recovery technologies, announced today that it has received an expanded U.S. Food and Drug Administ... Devices, Cardiology, FDA Abiomed, Impella, ventricular support, Cardiomyopathy, Cardiogenic Shock (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 13, 2018 Category: Pharmaceuticals Source Type: news
Abiomed touts expanded Impella heart pump indication, launches Women ’s Initiative
Abiomed (NSDQ:ABMD) said today it won expanded FDA premarket approval for its Impella 2.5, Impella CP, Impella 5.0 and Impella LD heart pumps, now cleared to provide treatment for heart failure associated with cardiomyopathy leading to cardiogenic shock, including peripartum and postpartum cardiomyopathy.
The approval follows a previous FDA indication the Danvers, Mass.-based company won in April 2016 that cleared the device for treating acute myocardial infarction cardiogenic shock and post-cardiotomy cardiogenic shock.
Abiomed touts its Impella heart pumps as the only percutaneous temporary ventricular support devices ...
Source: Mass Device - February 13, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiovascular Catheters Food & Drug Administration (FDA) Regulatory/Compliance Abiomed Source Type: news
Living too far from advanced cardiac care decreases your odds of survival
(Elsevier) A new study published in the Canadian Journal of Cardiology determined that patients with acute cardiac syndrome (ACS) and cardiogenic shock (CS), who live far from the only cardiac catheterization facility in Nova Scotia, Canada, have a survival rate about half that of patients with more direct access. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - January 31, 2018 Category: International Medicine & Public Health Source Type: news
Qool Therapeutics raises $8m to support temp management device
Early stage med device developer Qool Therapeutics said today it raised $8 million in a Series A-1 round to support development and trials of its Qool device designed for targeted temperature management and exercise recovery.
Joining the funding round was Zhongji Holdings and Join Medical Technology, Tampcap LLC, BrilliMedical International, BioPacific Investors, Western Technology Investment and FundRx, the Silicon Valley-based company said.
Qool Therapeutics said that in addition to the funding, it has also received an award from the US Department of Defense’s Defense Innovation unit Experimental organization.
The ...
Source: Mass Device - November 28, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Research & Development Respiratory qooltherapeutics Source Type: news
Revascularization in CS: Keep It Simple and Get Out of Dodge Revascularization in CS: Keep It Simple and Get Out of Dodge
Drs Harrington, Batchelor, and O ' Donoghue discuss the implications of the TCT late-breaking CULPRIT SHOCK trial testing culprit-only vs multivessel revascularization in unstable patients in cardiogenic shock.theheart.org on Medscape (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - November 13, 2017 Category: Consumer Health News Tags: Cardiology Commentary Source Type: news
Nov 3 Cardiology News Nov 3 Cardiology News
The ORBITA sham-control PCI study, Watchman, revascularization in cardiogenic shock, Absorb BVS, quality-of-life outcomes after PCI or bypass, and chronic total occlusion PCI are discussed in this week ' s podcast.theheart.org on Medscape (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - November 3, 2017 Category: Cardiology Tags: Cardiology News Source Type: news
Successful cardiogenic shock treatment using a percutaneous left ventricular assist device
(Osaka University) The Cardiovascular Surgery Group at Osaka University succeeded in minimally invasive treatment of a patient with acute heart failure due to medical treatment-resistant cardiogenic shock by making use of Impella, a percutaneous auxiliary artificial heart, for the first time in Japan. This method is anticipated as a new therapy for treating patients with acute heart failure due to medical treatment-resistant cardiogenic shock. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - October 31, 2017 Category: International Medicine & Public Health Source Type: news
Should patients with cardiogenic shock receive culprit lesion only PCI or multivessel PCI?
(Cardiovascular Research Foundation) Results from the prospective, randomized, multicenter CULPRIT-SHOCK trial found that an initial strategy of culprit lesion only percutaneous coronary intervention (PCI) reduces the composite of 30-day mortality and/or severe renal failure in patients with multivessel disease and cardiogenic shock complicating acute myocardial infarction. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - October 31, 2017 Category: International Medicine & Public Health Source Type: news
Multivessel PCI Not Best in Cardiogenic Shock
(MedPage Today) -- Trial data show mortality disadvantage versus treating culprit lesions only (Source: MedPage Today Nephrology)
Source: MedPage Today Nephrology - October 30, 2017 Category: Urology & Nephrology Source Type: news
New AHA Scientific Statement on Cardiogenic Shock New AHA Scientific Statement on Cardiogenic Shock
The statement provides a management algorithm integrating medical, surgical, and mechanical circulatory support therapies and calls for the development of regionalized systems of care.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 26, 2017 Category: Consumer Health News Tags: Cardiology News Source Type: news
