Post PCI symmetry important for good clinical outcome
Postprocedural asymmetry following percutaneous coronary intervention is associated with an increased risk of adverse clinical outcome, particularly in patients with suboptimal expansion, researchers report. (Source: MedWire News)
Source: MedWire News - June 8, 2016 Category: Consumer Health News Tags: Interventional cardiology Source Type: news

Unsafe antiplatelet use persists in PCI patients
Contraindicated antiplatelet use is rare but persists in patients undergoing percutaneous coronary intervention, show US study data. (Source: MedWire News)
Source: MedWire News - June 8, 2016 Category: Consumer Health News Tags: Interventional cardiology Source Type: news

EuroPCR 2016 Roundup: TAVR innovations, FFR systems in the spotlight
St. Jude Medical (NYSE:STJ) announced it won CE Mark approval in the European Union for its PressureWire X Guidewire fractional flow reserve measurement system and is launching the product in Europe. The company announced the launch and clearance at the EuroPCR meeting in Paris this week. “Fractional flow reserve has become an indispensable tool for assessing coronary lesions and making informed treatment decisions during percutaneous coronary intervention. The improved design of the new PressureWire X guidewire tip will simplify the fractional flow reserve procedure by enabling access to lesions in patients with to...
Source: Mass Device - May 18, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Drug-Eluting Stents Replacement Heart Valves Stent Grafts Biotronik Edwards Lifesciences EuroPCR 2016 InspireMD Leerink Partners Medinol Ltd Reva Medical Inc. St. Jude Medical Source Type: news

EuroPCR 2016 Update: TAVR innovations, FFR systems in the spotlight
UPDATED May 20, 2016, with more results out of Paris. St. Jude Medical (NYSE:STJ) announced it won CE Mark approval in the European Union for its PressureWire X Guidewire fractional flow reserve measurement system and is launching the product in Europe. The company announced the launch and clearance at the EuroPCR meeting in Paris this week. “Fractional flow reserve has become an indispensable tool for assessing coronary lesions and making informed treatment decisions during percutaneous coronary intervention. The improved design of the new PressureWire X guidewire tip will simplify the fractional flow reserve proce...
Source: Mass Device - May 18, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Drug-Eluting Stents Replacement Heart Valves Stent Grafts Biotronik Edwards Lifesciences EuroPCR 2016 InspireMD Leerink Partners Medinol Ltd Reva Medical Inc. St. Jude Medical Source Type: news

2016: Optimal imaging matches intravascular ultrasound for guiding PCI EuroPCR
(PCR) The first study to compare optimal frequency domain imaging (OFDI) with intravascular ultrasound (IVUS) to guide percutaneous coronary intervention (PCI) shows equivalent clinical outcomes with both imaging techniques. The study authors say the positive findings for OFDI support a class IIa recommendation in guidelines. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - May 17, 2016 Category: Global & Universal Source Type: news

EuroPCR 2016: Polymer-free coronary stent more effective & safer than BMS in ACS patients
(PCR) Results from a prespecified sub-study of the LEADERS FREE trial in patients with acute coronary syndromes and high risk for bleeding show lower rates of target lesion revascularisation and fewer adverse events after undergoing percutaneous coronary intervention with a polymer-free drug-coated stent than with a bare metal stent. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - May 17, 2016 Category: Global & Universal Source Type: news

Orthofix Announces 510(k) Clearance and US Limited Market Launch of FORZA PTC Interbody Spacer System
LEWISVILLE, Texas--(Healthcare Sales & Marketing Network)--Orthofix International N.V. (OFIX), a diversified, global medical device company, today announced the 510(k) clearance and U.S. limited market launch of the FORZA® PTC™ (Peek Titanium Composite... Devices, Orthopaedic, Neurosurgery, FDAOrthofix International, FORZA PTC, interbody spacers, spine surgery (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - May 16, 2016 Category: Pharmaceuticals Source Type: news

Young women at greater risk for adverse outcomes following PCI
Women younger than 55 years of age who undergo percutaneous coronary intervention for acute coronary syndrome are more likely to experience one-year adverse cardiovascular events due to risk factors such as diabetes and chronic kidney disease, yet they are less likely to receive potent antiplatelet therapy than men. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - May 6, 2016 Category: Science Source Type: news

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