Ocular Complications After Cardiac InterventionOcular Complications After Cardiac Intervention
Retinal artery occlusion is a potential complication of percutaneous coronary intervention. Find out what there is to know. BMC Ophthalmology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - April 26, 2016 Category: Consumer Health News Tags: Ophthalmology Journal Article 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
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
Percutaneous Coronary Intervention Increases Risk of CataractsPercutaneous Coronary Intervention Increases Risk of Cataracts
The risk of cataracts increases after percutaneous coronary intervention (PCI), suggesting the need for eye protection in patients undergoing these procedures, researchers from Taiwan report. Reuters Health Information (Source: Medscape Ophthalmology Headlines)
Source: Medscape Ophthalmology Headlines - April 5, 2016 Category: Opthalmology Tags: Internal Medicine News Source Type: news
FDA clears Corindus Vascular Robotics CorPath for peripheral interventions
Corindus Vascular Robotics (NYSE:CVRS) said today that it won FDA 510(k) clearance for its robotic-assisted CorPath system for peripheral interventions, a year after launching a clinical trial.
The clearance was based on the 20-patient Rapid trial, a prospective, single-arm, single-center study designed to look at the safety and effectiveness of the CorPath device in peripheral artery disease patients with lower-extremity blockages.
“For the past 2 years, I have been successfully treating my coronary patients with robotic precision while protecting my staff and me from the hazards of radiation exposure in the c...
Source: Mass Device - March 29, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Robot-Assisted Surgery Corindus Vascular Robotics Peripheral Artery Disease Source Type: news
Abiomed, FDA come to terms on Impella PMA requirements
Abiomed (NSDQ:ABMD) said yesterday that it came to terms with the FDA over the indications for use for its Impella line of cardiac assist devices and doesn’t believe it will have to appear before 1 of the agency’s advisory panels.
Danvers, Mass.-based Abiomed said the federal safety watchdog agreed on the indication for treating patients in cardiogenic shock after a heart attack or cardiac surgery with its Impella 2.5, Impella CP, Impella 5.0 and Impella LD devices.
“Based on the information available to the company to date, including multiple discussions with the FDA, the company no longer anticipates ...
Source: Mass Device - March 22, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Assist Devices Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Abiomed Inc. Source Type: news
UPDATE: FDA panel OKs Abbott’s Absorb stent
UPDATED March 16 with comments from panel members.
An FDA advisory panel recommended approval for the Absorb bioresorbable stent made by Abbott (NYSE:ABT).
The Circulatory Devices panel voted 9-1 on safety, 10-0 on efficacy and 9-1 on the risk-benefit profile for the Absorb device, a coronary scaffold that’s designed to elute the drug everolimus before dissolving entirely over a period of months. The FDA is not bound to follow the recommendations of its advisory panel but often does.
“I do believe this is a novel breakthrough technology for patients undergoing [percutaneous coronary intervention],” said...
Source: Mass Device - March 15, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Clearance Stents Abbott Source Type: news
Studying for USMLE Step 2? Master this most missed question
Studying for the United States Medical Licensing Examination® (USMLE®) Step 2 may seem daunting, but not to fear. Starting this month, we’re giving you an exclusive scoop on the most missed USMLE Step 2 test prep questions and expert strategies to help you beat them. Check out this month’s most challenging question, and view an expert video explanation of the answer from Kaplan Medical.
Welcome to the first Step 2 post in AMA Wire’s® series, “Tutor talk: Tips from Kaplan Medical on the most missed USMLE test prep questions from Kaplan’s Qbank.” Each month, we’re revealing the top questions students miss...
Source: AMA Wire - February 24, 2016 Category: Journals (General) Authors: Amy Farouk Source Type: news
Cambus Medical Launches New Over-Molding Solution To Reduce Cost, Time to Market
Cambus Medical, a Freudenberg Medical joint venture company, announced the launch of an innovative new over-molded Hub & Strain relief solution for Hypotube-based catheter shafts commonly used in Percutaneous Transluminal Coronary Angioplasty (PTCA) and other minimally invasive medical devices used in diagnostic and therapeutic interventions. (Source: Medical Design Online News)
Source: Medical Design Online News - February 10, 2016 Category: Medical Equipment Source Type: news
Medtech approvals: FDA releases November 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in November 2015:
Summary of PMA Originals & Supplements Approved
Originals: 3
Supplements: 69
Summary of PMA Originals Under Review
Total Under Review: 57
Total Active: 30
Total On Hold: 27
Summary of PMA Supplements Under Review
Total Under Review: 583
Total Active: 433
Total On Hold: 150
Summary of All PMA Submissions
Originals: 4
Supplements: 75
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 69
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 193.4
FDA Time: 1...
Source: Mass Device - January 22, 2016 Category: Medical Equipment Authors: MassDevice Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
EMS & Hospital Collaborations Strengthen Relationships and Improve Care in North Carolina
In North Carolina, the Regional Approach to Cardiovascular Emergencies (RACE) system was used to develop collaboration between first responders, EMS and emergency and cardiology departments. Initially, the RACE project was established in 2003 to treat acute ST-segment elevation myocardial infarction (STEMI), but in 2010, with the help of the HeartRescue Project, it was expanded to improve regional care for out-of-hospital cardiac arrest patients.
System Design & Improvement Efforts
The RACE project began by developing coordinated and pre-specified plans for the diagnosis and rapid reperfusion of STEMI patients, startin...
Source: JEMS Administration and Leadership - November 30, 2015 Category: Emergency Medicine Authors: Carolina Malta Hansen, MD Tags: Cardiac & Resuscitation Shock Leadership Professionalism Source Type: news
EMS & Hospital Collaborations Strengthen Relationships and Improve Care in North Carolina
In North Carolina, the Regional Approach to Cardiovascular Emergencies (RACE) system was used to develop collaboration between first responders, EMS and emergency and cardiology departments. Initially, the RACE project was established in 2003 to treat acute ST-segment elevation myocardial infarction (STEMI), but in 2010, with the help of the HeartRescue Project, it was expanded to improve regional care for out-of-hospital cardiac arrest patients.
System Design & Improvement Efforts
The RACE project began by developing coordinated and pre-specified plans for the diagnosis and rapid reperfusion of STEMI patients, startin...
Source: JEMS Patient Care - November 30, 2015 Category: Emergency Medicine Authors: Carolina Malta Hansen, MD Tags: Cardiac & Resuscitation Shock Leadership Professionalism Source Type: news
Still No Mortality Benefit for PCI in Stable Ischemia (FREE)
By Harlan Krumholz, MD, SM
Dr. Krumholz is editor-in-chief of NEJM Journal Watch Cardiology, from which this story was adapted. See full coverage at the link below.Percutaneous coronary intervention (PCI) for the treatment of stable ischemic heart disease offers no longer-term survival benefit compared with initial medical therapy alone, … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - November 12, 2015 Category: Primary Care Source Type: news
Who Might Benefit from Long-Term DAPT? Risk Score May Help (FREE)
By Kelly Young
Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM
Researchers have developed a risk score to determine which percutaneous coronary intervention (PCI) patients would benefit most from continuing dual antiplatelet therapy (DAPT) beyond 12 months, according to results presented at the American Heart Association's annual meeting.In the DAPT study, nearly 12,000 patients who'd … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - November 10, 2015 Category: Primary Care Source Type: news
