Abiomed Earns FDA Approval for Adding Optical Sensor to Impella CP Heart Pump
Abiomed, which had a busy 2017 and was among our Company of the Year finalists, reported today that it has received FDA premarket approval (PMA) for its Impella CP heart pump with SmartAssist, utilizing an optical sensor. The sensor is one component of the SmartAssist technology, which also includes a software update enabling informational displays of left ventricular pressure (LVP), end-diastolic pressure (EDP), and cardiac power output (CPO) data on the Impella Console, an Abiomed spokesperson told MD+DI.
The Impella CP heart pump had already earned FDA approval for treating patients in cardiogenic shock as well as patie...
Source: MDDI - April 2, 2018 Category: Medical Devices Authors: Daphne Allen Tags: Cardiovascular Source Type: news
Foxtrot ™ NC PTCA Gains Regulatory Approval in Malaysia
(Source: Microport News Release)
Source: Microport News Release - March 29, 2018 Category: Medical Devices Source Type: news
FDA clears robotic movement software from Corindus
The FDA granted 510(k) clearance to the first automated robotic movement software designed for Corindus Vascular Robotics (OTC:CVRS) CorPath GRX percutaneous coronary intervention platform, the company reported today.
The Rotate on Retract feature allows the person operating the CorPath GRX to navigate to a targeted lesion by automatically turning the guidewire upon joystick retraction.
The software also won CE Mark approval in the European Union earlier this year. Today, Dr. Nelson Bernado, the medical director of MedStar Heart Institute’s Peripheral Vascular Laboratory, is slated to perform a robotic-assited perip...
Source: Mass Device - March 5, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Food & Drug Administration (FDA) Regulatory/Compliance Robotics Software / IT Vascular Corindus Vascular Robotics Source Type: news
ACC, Saudi Arabian Cardiac Interventional Society partner on registries
(American College of Cardiology) The American College of Cardiology and the Saudi Arabian Cardiac Interventional Society have partnered to implement the National Cardiovascular Data Registry's (NCDR) CathPCI Registry in hospitals across Saudi Arabia. The CathPCI Registry assesses the characteristics, treatments and outcomes of heart disease patients who receive diagnostic catheterization as well as percutaneous coronary intervention procedures. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - February 27, 2018 Category: International Medicine & Public Health Source Type: news
Abiomed wins expanded Impella FDA nod for elective, urgent high-risk PCI
Abiomed (NSDQ:ABMD) said today it won expanded FDA premarket approval for its Impella 2.5 and Impella CP heart pumps, now cleared for use during elective and urgent high risk percutaneous coronary intervention procedures.
With the expansion, the Impella heart pump is cleared for use with patients with severe coronary artery disease, complex anatomy and a number of co-morbidities with or without depressed ejection fractions, the Danvers, Mass.-based company said.
“This expanded FDA approval with moderately reduced ejection fraction validates our real-world experience using hemodynamic support in patients turned down ...
Source: Mass Device - February 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiovascular Catheters Food & Drug Administration (FDA) Regulatory/Compliance Abiomed Source Type: news
Shorter time between first medical contact to PCI in heart patients linked to saving lives
(European Society of Cardiology) Heart experts are calling for immediate action following new research in the European Heart Journal that shows every minute counts for patients who suffer the most severe type of heart attack. The study shows numbers of deaths rise steadily and rapidly the longer the time between patients' first contact with a medical professional and when they are treated in hospital with percutaneous coronary intervention (PCI) to insert a balloon catheter to widen blocked arteries and restore blood flow to the heart. (Source: EurekAlert! - Social and Behavioral Science)
Source: EurekAlert! - Social and Behavioral Science - February 13, 2018 Category: International Medicine & Public Health Source Type: news
Doctors may be ordering too many coronary interventions
Physicians may be ordering too many percutaneous coronary intervention procedures...Read more on AuntMinnie.comRelated Reading:
FFR-CT algorithm guides management of revascularization
Use criteria cut unnecessary heart interventions
NIH study ties soft plaque on CT to cardiac risk factors (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - January 16, 2018 Category: Radiology Source Type: news
Percutaneous coronary intervention is a well-justified option also in severe coronary artery disease
(University of Eastern Finland) The treatment of left main coronary artery disease by percutaneous coronary intervention is associated with a smaller risk of severe cardiovascular events than coronary artery bypass grafting in the weeks following surgery. A meta-analysis of several trials and nearly 5,000 patients revealed no differences in mortality between the two treatments. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - December 11, 2017 Category: International Medicine & Public Health Source Type: news
Robocath adds $2m for new neurovascular platform
Medical robotics startup Robocath said today that it added about $2 million (€1.7 million) to the more than $5 million it raised earlier this year, taking its total to $7.5 million in funding this year.
Rouen, France-based Robocath, which is developing the R-One robotic platform for coronary angioplasty, is pursuing CE Mark approval in the European Union for the system. R-One is expected to hit the market in Europe and the Middle East next year, the company said.
Get the full story at our sister site, The Robot Report.
The post Robocath adds $2m for new neurovascular platform appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - December 6, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Robotics Wall Street Beat Robocath Source Type: news
FOXTROT ™ NC PTCA Balloon Catheter Gains Regulatory Approval in Argentina
(Source: Microport News Release)
Source: Microport News Release - November 24, 2017 Category: Medical Devices Source Type: news
When to Stent in Stable CAD? That Is (Still) the Question When to Stent in Stable CAD? That Is (Still) the Question
Drs Harrington, Maron, and Patel discuss the ORBITA trial, which compared coronary stenting with sham percutaneous coronary intervention for angina relief. Why did ORBITA cause so much buzz?theheart.org on Medscape (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - November 22, 2017 Category: Consumer Health News Tags: Cardiology Commentary Source Type: news
Perioperative Aspirin Might Benefit Patients with Prior PCI
Perioperative aspirin seems beneficial for high-risk patients undergoing noncardiac surgery who've previously undergone percutaneous coronary intervention (PCI), according to a subanalysis from the POISE... (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - November 14, 2017 Category: Primary Care Source Type: news
Aspirin can prevent heart attacks after noncardiac surgery in patients with prior PCI
(University of Alberta Faculty of Medicine& Dentistry) A Canadian-led study has found that perioperative aspirin can prevent heart-related complications after major noncardiac surgery in patients with previous percutaneous coronary intervention (PCI) such as an angioplasty or stent. The study found that for every 1,000 patients with PCI, giving them aspirin at the time of noncardiac surgery would prevent 59 heart attacks and cause eight major bleeding events. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - November 14, 2017 Category: International Medicine & Public Health Source Type: news
Study: PCI Appears No Better Than Sham Procedure in Patients with Stable Angina (FREE)
By Kelly Young
Edited by Andr é Sofair, MD, MPH, and William E. Chavey, MD, MS
Percutaneous coronary intervention (PCI) didn ' t improve exercise time relative to a sham procedure in patients with stable angina and severe coronary stenosis. Findings from the ORBITA study were published in the Lancet and presented at the … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - November 3, 2017 Category: Primary Care Source Type: news
Analysis Shows Better Health Outcomes and Cost Effectiveness for Coronary Intervention Using Abbott's Fractional Flow Reserve (FFR) Diagnostic in Patients with Stable Coronary Artery Disease
After three years, patients who underwent FFR-guided percutaneous coronary intervention (PCI) in combination with medical therapy had significantly fewer major adverse cardiac events compared to patients who received medical therapy alone (Source: Abbott.com)
Source: Abbott.com - November 2, 2017 Category: Pharmaceuticals Source Type: news
