Edwards Lifesciences Recalls Swan-Ganz hemodynamic catheters.

Edwards Lifesciences is recalling its 131F7, 131F7J, 131F7P, 131VF7P, 151F7 Swan-Ganz Thermodilution Catheters manufactured Dec. 26, 2017, to April 19, 2018 due, to incorrect assembly that reversed the catheter lumens. This recall includes 1,426 devices in the United States.

February 5, 2019 – The American Society of Echocardiography (ASE) released a new document that provides a comprehensive review of the optimal application of transesophageal echocardiography (TEE) for patients with congenital heart disease (CHD).

Stroke survivors have better quality of life three months after their stroke if the clot that caused the stroke was mechanically removed even hours beyond the ideal treatment window compared to those treated with drugs alone. This preliminary research will be presented, Feb. 6-8 in Honolulu at the American Stroke Association’s International Stroke Conference 2019.

The Abiomed Impella RP had higher than expected mortality in its post approval study, much higher than in its pre-market approval study. The vendor and the FDA believe this might be due to poor patient selection and implanting the device too late to aid the patient.

The U.S. Food and Drug Administration (FDA) sent a letter to cardiologists this week to explain its evaluation of high mortality rates reported in the Abiomed Impella RP heart pump post-approval study (PAS). The FDA believes the mortality rate might be higher than the pre-market study because of inappropriately selected patients receiving the device.

In 2018, capital investment in companies developing artificial intelligence (AI)-enabled medical image analysis solutions was almost $580 million. This was more than double the investment into such companies in 2017, according to market research firm Signify Research.

Canon Medical Systems USA recently introduced its next generation of interventional systems – the Alphenix platform. The new flagship platform of systems incorporates all-new features that enable clinicians to deliver images with clarity and precision without compromising workflow and while prioritizing low dose.

Biosense Webster has enrolled and treated the first patient in its U.S. Investigational Device Exemption (IDE) study evaluating the company’s QDot Micro radiofrequency (RF) ablation catheter in the treatment of symptomatic drug-refractory paroxysmal atrial fibrillation (AF). The first AF patient was treated at NYU Langone Health’s Heart Rhythm Center in New York City, one of up to 30 centers participating in the study that will enroll up to 185 patients throughout the U.S.

Stryker has recalled its LifePak 15 defibrillator-monitor system because it may lock up after delivering a shock to a patient. The defibrillator was originally made by Physio-Control, before being purchased by Stryker.

February 4, 2019 — Stryker announced Feb. 1, the company is launching a voluntary field action on specific units of the LifePak 15 Monitor/Defibrillators. The company is notifying certain customers of an issue that may cause the device to lock up after a defibrillation shock is delivered. 

Paragonix Technologies Inc. recently received clearance from the U.S. Food and Drug Administration (FDA) for a design enhancement allowing for the use of the Paragonix SherpaPak Cardiac Transport System (CTS) with small and pediatric donor hearts. Starting in Q1 2019, the system will now be shipped with heart connectors covering most aortic diameters, permitting the anchoring of various size hearts including small pediatric hearts to its proprietary suspension system for improved donor heart transport.

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