New Approval Extends Impella ’s Support Time
Abiomed has received a nod from FDA to expand the Impella 5.0 and Impella LD PMA’s labeling for the treatment of cardiogenic shock. The agency has approved the Danvers, MA-based company’s Impella to provide support 10 to 14 days.
Prior to the expansion, the pump was only at six days.
Abiomed’s Impella 5.0 and the Impella LD are forward flow heart pumps that deliver up to 5 L/min, stabilizing a patient’s hemodynamics, unloading the left ventricle, and perfusing the end organs, allowing for the potential of native heart recovery or return to heart functi...
Source: MDDI - May 14, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news
Cardiac Assist Devices in Cardiogenic Shock Cardiac Assist Devices in Cardiogenic Shock
A new study examines the use of the Impella CP cardiac assist device in patients with acute MI complicated by cardiogenic shock. What are the implications of the findings?Circulation (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - April 19, 2019 Category: Consumer Health News Tags: Cardiology Journal Article Source Type: news
Abiomed touts new Impella study results
Abiomed’s Impella 2.5 pump (Image from Abiomed)
New data on Abiomed (NSDQ:ABMD) Impella heart pumps show a 34% increase in survival among nearly 5,000 patients treated with the company’s devices intended to treat cardiogenic shock when combined with best practices, according to a company study.
The study of patients treated at 763 U.S. sites between April 1, 2018 and March 28, 2019 showed median survival rates had risen from 51% in 2016, when the FDA granted premarket approval for the Impella 2.5, CP, 5.0 and LD heart pumps, to 67%, the Danvers, Mass.-based company said. (The FDA approved Impella 2.5 for high-ris...
Source: Mass Device - April 5, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Source Type: news
ACC 2019 Roundup: Abiomed Impella RP post-market study shows benefit in select patient group
Abiomed (NSDQ:ABMD) today released 18-month post-approval study data from patients treated with its Impella RP, touting a benefit to survival for specifically selected “Recover Right” protocol patients.
Results from the study were presented at the American College of Cardiology’s 68th Annual Scientific Sessions in New Orleans, the Danvers, Mass.-based company said.
The review follows a release posted by the FDA last month warning of a 17.4% survival rate with the Impella RP heart pump system, approximately 55% lower than the rate noted in the premarket study of the device.
Abiomed said that it met with the F...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Featured Patient Monitoring Replacement Heart Valves Abbott Abiomed Medtronic Source Type: news
A Push for Push Dose Epinephrine
You transport a 79-year-old woman to the hospital for fever and urinary incontinence. Her family mentions a history of frequent urinary tract infections. Her initial vital signs are a heart rate of 115 bpm, an oxygen saturation of 97% on room air, and a blood pressure of 105/75 mmHg.
You establish a peripheral IV line and begin a bolus of normal saline.
About 15 minutes away from the hospital, you note the patient becomes increasingly drowsy. Her heart rate has increased to 125 bpm and her blood pressure is now 85/47 mmHg. What are your next steps?
Prehospital Shock
Starting in 2018, push dose epinephrine replaced dopamine...
Source: JEMS Patient Care - March 14, 2019 Category: Emergency Medicine Authors: Sammy Hodroge, MD Tags: Training Cardiac & Resuscitation Top Story Exclusive Articles Patient Care Source Type: news
A Nail in the Coffin for IABP in AMI With Cardiogenic Shock A Nail in the Coffin for IABP in AMI With Cardiogenic Shock
A 6-year follow-up of the IABP-SHOCK II study confirms lack of benefit on mortality associated with IABP placement in the setting of MI-associated cardiogenic shock.Circulation (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - February 19, 2019 Category: Consumer Health News Tags: Cardiology Journal Article Source Type: news
Life and Times of Leading Cardiologists: Holger Thiele Life and Times of Leading Cardiologists: Holger Thiele
Holger Thiele ' s career in cardiogenic shock began in West Berlin where he witnessed the fall of the wall and moved to Leipzig to pursue cardiology. This former ironman still bikes to the hospital.theheart.org on Medscape (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - February 14, 2019 Category: Consumer Health News Tags: Cardiology Commentary Source Type: news
FDA: Interim data from post-market Abiomed Impella RP study shows 17% survival rate
The FDA yesterday said that interim data from a post-approval study of Abiomed‘s (NSDQ:ABMD) Impella RP heart pump system showed only a 17.4% survival rate, approximately 55% lower than the rate noted in the premarket study of the device.
The federal watchdog said that it is currently evaluating data from the study and that it will continue to monitor survival rates, but added that it still believes the system’s benefits outweigh the risks when used correctly.
In premarket clinical trials, results indicated a 73.3% survival rate to 30 days post device explant or hospital discharge, or to the start of the next long...
Source: Mass Device - February 5, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiovascular Clinical Trials Featured Food & Drug Administration (FDA) Abiomed Source Type: news
AHA: Cardiogenic Shock Ups Mortality in Takotsubo Syndrome
TUESDAY, Nov. 13, 2018 -- For patients with takotsubo syndrome (TTS), those with cardiogenic shock (CS) have an increased risk for mortality, according to a research letter published online Nov. 10 in Circulation to coincide with the annual meeting... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - November 13, 2018 Category: Pharmaceuticals Source Type: news
Abiomed shares slide despite Impella CP trial success
Abiomed (NSDQ:ABMD) shares fell approximately 13.1% yesterday despite the company announcing positive results from a pilot trial of its Impella CP heart pump that will clear the way for a pivotal that could nearly double the device’s total addressable market.
The company announced on Sunday that a pilot study of its Impella CP, used to unload the left ventricle for patients presenting with anterior ST-segment elevation myocardial infarction without cardiogenic shock met its primary endpoints and that it plans to launch a pivotal trial during the second half of next year.
Leerink Partner analyst Danielle Antalffy sai...
Source: Mass Device - November 13, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Assist Devices Cardiovascular Catheters Featured Wall Street Beat Abiomed Source Type: news
Abiomed ’s Successful Pilot Study Leads to Pivotal Trial
Abiomed shares were down as much as 17% despite announcing positive data for its Impella CP. The Danvers, MA-based company presented the data from the 50-patient pilot trial at the American Heart Association annual conference in Chicago and said because of the favorable data it would now move to a pivotal trial.
The results of the FDA STEMI Door-to-Unloading safety and feasibility randomized controlled trial, show unloading the left ventricle with Impella CP for 30 minutes prior to reperfusion in patients presenting with anterior ST-segment elevation myocardial infarction (STEMI) without cardiogenic shock is safe and feasi...
Source: MDDI - November 12, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news
Medical News Today: Broken heart syndrome: How complications affect death risk
New research has examined the effect of cardiogenic shock on long- and short-term mortality risk among people with broken heart syndrome. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - November 8, 2018 Category: Consumer Health News Tags: Heart Disease Source Type: news
Abiomed Responds to MedSun Report on Two Impella Pumps
Editor's note: This story has been updated from the original story to include comments from Abiomed.
A report published through FDA's medical product safety network (MedSun) database describes two issues that involve Abiomed's Impella heart pumps. However, the company told MD+DI that the information in the MedSun report is inaccurate.
According to the report, which is located here on FDA's website, one Impella pump reportedly had an unknown "material" inside the pump, causing it to have flows "less than expected," and another pump's housing/outlet cage and impeller were somehow crushed a...
Source: MDDI - October 12, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Implants Source Type: news
Benefit Persists for Culprit-Lesion-Only PCI in MI With Shock Benefit Persists for Culprit-Lesion-Only PCI in MI With Shock
One-year follow-up of the CULPRIT-SHOCK trial shows the advantage conferred by PCI only of the culprit lesion vs immediate multivessel PCI at 30 days persists in MI complicated by cardiogenic shock.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - August 26, 2018 Category: Consumer Health News Tags: Cardiology News Source Type: news
ESC: Multivessel PCI Disappoints Longer-Term in Cardiogenic Shock
(MedPage Today) -- ' Less is more ' still true in CULPRIT-SHOCK trial (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - August 25, 2018 Category: Cardiology Source Type: news
