Abiomed launches quality assurance program for Impella heart pump
Abiomed (NSDQ:ABMD) said today it launched the Impella quality assurance program, looking to improve outcomes for cardiogenic shock and protected PCI patients.
The Danvers, Mass.-based company said the program will use data from its IQ Database, which includes observational quality assurance data on over 95% of Impella patients since 2008, including more than 44,000 Impella case entries.
The IQ program will complement best practices alongside Abiomed’s 250-person clinical field team, the company said.
“Abiomed has created the largest high-risk PCI and cardiogenic shock database of real-world evidence with dif...
Source: Mass Device - November 1, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Cardiovascular Abiomed Inc. Source Type: news
Japanese regulators approve Abiomed ’ s Impella heart pumps
Abiomed (NSDQ:ABMD) said today that it won approval from the Japanese Ministry of Health, Labor & Welfare’s Pharmaceuticals & Medical Devices Agency for its Impella line of heart pumps.
The Danvers, Mass.-based company said its devices are the “1st and only percutaneous temporary ventricular support devices” to win Japanese PMDA approval and be deemed safe and effective for their indication.
“This approval marks a significant milestone to provide Impella hemodynamic support for heart failure patients. We commend the dedication of Japanese physicians and regulatory bodies in searching for ...
Source: Mass Device - September 27, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Regulatory/Compliance Abiomed Inc. Japanese Pharmaceuticals and Medical Devices Agency Source Type: news
A Novel Approach to the Shocky Child
Start with three quick bedside ultrasounds and you might avoid an unnecessary IV push
An 11-year-old boy is brought to your emergency department following a few hours of persistent vomiting, irritability and decreasing activity. His mother also reports about two days of fever, decreased appetite and nasal stuffness.
On initial evaluation, his vital signs include a heart rate of 128 beats/minute, blood pressure of 82/64 mmHg, respirations of 24 breaths/minute and temperature of 101.50F. Pulse oximetry reveals 98% saturation on room air while capillary refill time is approximately 5 seconds. His activity is reduced an...
Source: EPMonthly.com - September 27, 2016 Category: Emergency Medicine Authors: Matt McGahen Tags: Uncategorized Source Type: news
Public Reporting for PCI, Cardiogenic Shock: Clarity or Confusion? Public Reporting for PCI, Cardiogenic Shock: Clarity or Confusion?
"It may simply be time to recognize that mortality following PCI is the wrong metric" to measure quality across diverse clinical scenarios, experts suggest.Heartwire from Medscape (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - August 11, 2016 Category: Cardiology Tags: Cardiology News Source Type: news
Abiomed posts solid Q1, lifts full year outlook
Abiomed (NSDQ:ABMD) lifted its revenue guidance for the year after posting a Street-beating 1st quarter today.
The Danvers, Mass.-based company reported profits of $12.9 million, or 29¢ per share, on sales of $103 million for the 3 months ended June 30. That amounts to a healthy 45.7% bottom-line gain as sales grew 40.3% compared with the same period last year.
Abiomed handily beat Wall Street analyst’s expectations of 23¢ in EPS and $97.2 million in revenue.
“Abiomed is creating a new era of medicine focused on the field of heart recovery and offering new treatment paradigms for high risk heart failure patients....
Source: Mass Device - July 28, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Abiomed Inc. Source Type: news
With End of Public Reporting, Better Tx of Cardiogenic Shock in NY (CME/CE)
(MedPage Today) -- Did reporting compromise care by increasing risk aversion? (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - July 27, 2016 Category: American Health Source Type: news
A case of mushroom poisoning with Russula subnigricans: development of rhabdomyolysis, acute kidney injury, cardiogenic shock, and death - Cho JT, Han JH.
Mushroom exposures are increasing worldwide. The incidence and fatality of mushroom poisoning are reported to be increasing. Several new syndromes in mushroom poisoning have been described. Rhabdomyolytic mushroom poisoning is one of new syndromes. Russula... (Source: SafetyLit)
Source: SafetyLit - July 7, 2016 Category: Global & Universal Tags: Home and Consumer Product Safety Source Type: news
Opinion Makers: Impella for Cardiogenic Shock
(MedPage Today) -- William O'Neill, MD, on why mortality of less than 20% is "very achievable" (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - July 6, 2016 Category: Cardiology Source Type: news
Revascularization Strategy in Acute MI With Cardiogenic ShockRevascularization Strategy in Acute MI With Cardiogenic Shock
What is the optimal revascularization strategy in patients with multivessel disease and acute myocardial infarction complicated by cardiogenic shock? American Heart Journal (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - April 14, 2016 Category: Consumer Health News Tags: Cardiology Journal Article Source Type: news
Abiomed Impella® Therapy Receives FDA Approval For Cardiogenic Shock After Heart Attack Or Heart Surgery
Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support technologies, today announced that it has received U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) for its Impella 2.5™, Impella CP®, Impella 5.0™ and Impella LD™ heart pumps to provide treatment of ongoing cardiogenic shock. (Source: Medical Design Online News)
Source: Medical Design Online News - April 11, 2016 Category: Medical Equipment Source Type: news
MassDevice.com +5 | The top 5 medtech stories for April 8, 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.
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5. Monteris wins FDA IDE clearance for NeuroBlate trial
Monteris Medical said today it won FDA investigational device exemption clearance for a trial of its NeuroBlate system for treating medically refractory epilepsy.
The NeuroBl...
Source: Mass Device - April 8, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well 5 Source Type: news
FDA Approves Impella Heart Pumps for Cardiogenic ShockFDA Approves Impella Heart Pumps for Cardiogenic Shock
The entire family of Impella left side heart pumps has been approved for cardiogenic shock. FDA Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - April 8, 2016 Category: Consumer Health News Tags: Cardiology News Source Type: news
Abiomed Adds Cardiogenic Shock to Approved Indications
(Source: MDDI)
Source: MDDI - April 8, 2016 Category: Medical Equipment Authors: mthibault Tags: News Regulatory and Legal Implantable Devices Source Type: news
FDA approves Abiomed’s Impella with indication for cardiogenic shock
Abiomed (NSDQ:ABMD) said today it won expanded FDA premarket approval indications for its Impella line of percutaneous heart pumps to treat patients suffering cardiogenic shock following acute myocardial infarction or cardiac surgery.
The Impella devices are now indicated for the stabilization of a patient’s hemodynamics, unloading of the left ventricle, perfusion of the end organs and to allow for recovery of the native heart, according to the Danvers, Mass.-based company.
“Abiomed would like to recognize our customers, physicians, nurses, scientists, regulators and employees for their last fifteen years of ci...
Source: Mass Device - April 7, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Pre-Market Approval (PMA) Abiomed Inc. Source Type: news
FDA clears Abiomed’s Impella with indication for cardiogenic shock
Abiomed (NSDQ:ABMD) said today it won expanded FDA premarket approval indications for its Impella line of percutaneous heart pumps to treat patients suffering cardiogenic shock following acute myocardial infarction or cardiac surgery.
The Impella devices are now indicated for the stabilization of a patient’s hemodynamics, unloading of the left ventricle, perfusion of the end organs and to allow for recovery of the native heart, according to the Danvers, Mass.-based company.
“Abiomed would like to recognize our customers, physicians, nurses, scientists, regulators and employees for their last fifteen years of ci...
Source: Mass Device - April 7, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Pre-Market Approval (PMA) Abiomed Inc. Source Type: news
