Percutaneous Coronary Intervention News 
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This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.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
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
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
PCI reduces need for additional drug even when blockages remain
This study does provide an important message for people who have residual disease following angioplasty,” said lead author Karen Alexander, M.D., professor of medicine at Duke and director of safety surveillance at the DCRI. “For patients who had angina prior to angioplasty, they were mostly asymptomatic following the angioplasty even though coronary blockages remained.”
Alexander and colleagues had set out to address whether the drug ranolazine, when added to standard medications in this population, would reduce symptoms along with hospitalizations and procedures over time. Ranolazine works at the heart muscle to le...
Source: DukeHealth.org: Duke Health Features - November 10, 2015 Category: Pediatrics Tags: Duke Medicine Source Type: news
TherOx wins FDA IDE nod for Supersaturated Oxygen therapy
Irvine, Calif.-based oxygenation therapy company TherOx said today it won FDA investigational device exemption approval to test its 2nd-generation Supersaturated Oxygen therapy system for treating acute myocardial infarction.
The company’s SSO2 therapy is designed to reduce infarct size by increasing oxygen delivery to heart muscle immediately after the coronary artery has been opened through a percutaneous coronary intervention procedure.
The system mixes highly oxygenated saline with a patient’s blood and delivers the mixture through a catheter to the targeted ischemic area of the heart, the company said.
...
Source: Mass Device - November 5, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Cardiovascular Food & Drug Administration (FDA) TherOx Inc Source Type: news
Trial Results Suggest St. Jude's Cardiac Assist Device Is Reliable During High-Risk PCI Procedures
St. Jude Medical, Inc.has announced results from the SHIELD I (Coronary InterventionSinHIgh-Risk PatiEnts Using a Novel PercutaneousLeft Ventricular SupportDevice) study that confirm the benefits of the HeartMate PHP(Percutaneous Heart Pump) cardiac assist device for patients undergoing high-risk percutaneous coronary intervention (PCI), a procedure to restore blood flow to the heart. (Source: Medical Design Online News)
Source: Medical Design Online News - October 15, 2015 Category: Medical Equipment Source Type: news
TCT 2015 Roundup: St. Jude Medical’s new HeartMate PHP pump
St. Jude Medical (NYSE:STJ) said today that its newly acquired HeartMate PHP heart pump met its safety and efficacy endpoints in the Shield I trial used to back its CE Mark approval last summer.
The results from Shield I’s 1st 30 patients led to the CE Mark nod in July. Today St. Jude said data from 46 subjects passed the primary safety endpoint of a composite of major adverse events and the primary efficacy endpoint of freedom from hemodynamic compromise during percutaneous coronary intervention.
The study results, released today at the annual Transcatheter Cardiovascular Therapeutics conference in San Francisco...
Source: Mass Device - October 14, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Catheters Clinical Trials Elixir Medical Corp. Micell Technologies Inc. St. Jude Medical Stentys TCT 2015 Tryton Medical Inc. Source Type: news
TCT 2015: Abbott’s Absorb meets endpoint in U.S. pivotal trial
The Absorb bioabsorbable stent made by Abbott (NYSE:ABT) met its primary endpoint in a U.S. clinical trial that will be used to back a bid for FDA approval, researchers said today at the annual Transcatheter Cardiovascular Therapeutics conference in San Francisco.
One-year data from the Absorb III trial of 2,008 patients showed that the Absorb device was non-inferior to Abbott’s flagship Xience drug-eluting stent. The Absorb device is designed to fully dissolve after delivering its anti-restenosis drug payload, unlike conventional drug-eluting stents what leave behind a metal scaffold.
The trial showed a rate of targ...
Source: Mass Device - October 12, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Stents Abbott Bioabsorbable Stents Source Type: news
Corindus Vascular, Mayo Clinic sign robotic PCI research deal
Corindus Vascular Robotics (OTC:CVRS) said today it signed a deal with the Mayo Clinic to form a joint robotic-assisted percutaneous coronary intervention research and clinical program.
The program will use Corindus’ CorPath robotic-assistance system designed for coronary PCI procedures. The system allows operating physicians to avoid radiation exposure and orthopedic strain from wearing lead protective vestments by operating from a remote location, the Waltham, Mass.-based company said.
“The occupational hazards in this field can be devastating to people. Vascular robotics provide the biggest change to cath l...
Source: Mass Device - October 12, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Clinical Trials Research & Development Robot-Assisted Surgery Robotics Corindus Vascular Robotics Source Type: news
