SJM, st. Jude Medical, FDA recall, Battery depletion, Recalls ICDs and CRT-D

October 25, 2016 — St. Jude Medical is recalling 251,346 of its Fortify, Unify and Assura implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) because the batteries can deplete prematurely. 

October 24, 2016 — Conventional smart clothing uses conductive fibers or rubber as sensing electrodes, and cardiac electrical sensing modules have required at least two or more electrodes to contact the skin for capturing the heart’s electrophysiological signals. However, a new start up company is now offering smart textiles without the need for electrodes. 

medicare bundled cardiac payments, CMS cardiology payments

(Editor’s note: This is the second part of a two-part series on the proposed Medicare five-year demonstration for a mandatory bundled payment system. Part 1 outlined the baseline capability requirements. Part 2 presents a model methodology for developing a successful bundled payment model as it applies to cardiac patients.)

October 24, 2016 — Medtronic received U.S. Food and Drug Administration (FDA) 510(k) clearance for the HawkOne Directional Atherectomy System in a new size for treating patients with peripheral artery disease (PAD). The HawkOne system is designed to remove plaque from the vessel wall and restore blood flow. The new HawkOne 6 French (6F) provides an effective and easy-to-use treatment option for patients with PAD both above and below the knee with a single device at a lower profile.

bioresorbable stents, bioabsorbable stents, visualizing the Absorb BVS, dissolving stent, disappearing stent on IVUS and OCT
Corpath, Corindus, robots in the cath lab, robotic PCI, robotic implantation of the Absorb BVS bioresorbable stent

There has been a lot of interest in the interventional community regarding the Abbott Absorb Bioresorbable Vascular Scaffold (BVS) since its U.S. Food and Drug Administration (FDA) approval in July. While adoption of this new, first-in-class bioresorbable stent has been embraced enthusiastically by many hospitals, there are important limitations to the device, which dictate how it needs to be deployed, patient selection and, most crucially, the need for very accurate measurements and deployment.  

October 20, 2016 — SentreHeart Inc. announced in late September the closing of a $35 million Series D round of financing. Deerfield Management Company, a healthcare investment firm, led the financing, which included participation from SentreHeart’s existing investors U.S. Venture Partners, Prospect Ventures, Vivo Capital and Decheng Capital.

Avinger Inc. recently announced that the company has received expanded indications from the U.S. Food and Drug Administration (FDA) recognizing the Pantheris Lumivascular atherectomy system as a technology that can be used for both therapeutic and diagnostic purposes.

St. Jude Medical Inc. announced the launch of the ADO II AS (AMPLATZER Duct Occluder II Additional Sizes) pediatric clinical trial. The U.S. IDE clinical trial will evaluate the safety and effectiveness of the St. Jude Medical Amplatzer Duct Occluder II AS (ADO II AS), a first-of-its-kind device specifically designed for closure of the small patent ductus arteriosus (PDA).

Medtronic plc announced last week that it has notified customers of a voluntary recall of certain lots of its Pipeline embolization device, Alligator retrieval device and X-Celerator hydrophilic guidewire. The recall also includes the stylet containing UltraFlow flow directed micro catheters and Marathon flow directed micro catheters. These products are produced, marketed and sold by Medtronic's Neurovascular business, which is part of the Brain Therapies division in the company's Restorative Therapies Group.

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