Medtronic plc last week unveiled new health economic analysis data from the FIRE AND ICE trial that favor cryoballoon catheter ablation over radiofrequency (RF) ablation related to trial period cost savings. The savings came as a result of fewer cardiovascular (CV) rehospitalizations and repeat ablations.

The Centers for Disease Control and Prevention (CDC) is warning healthcare providers and patients about the potential risk of infection from certain devices used during open-heart (open-chest) surgery.

Philips announced at The American College of Emergency Physicians' (ACEP) annual meeting that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its S4-1 cardiac transducer for Lumify, its smart-device diagnostic ultrasound solution. The pocket-sized and lightweight S4-1 transducer now offers advanced sensitivity and high-resolution 2-D image quality, along with new exam pre-sets, allowing clinicians to quickly triage and assess their patients.

HHS, Health and Human Services, MACRA, Quality Payment Program, Medicare physician payment

The Department of Health & Human Services (HHS) today finalized a landmark new payment system for Medicare clinicians that will continue the administration’s progress in reforming how the healthcare system pays for care. The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) Quality Payment Program, which replaces the flawed Sustainable Growth Rate (SGR), will equip clinicians with the tools and flexibility to provide high-quality, patient-centered care.

Biotricity Inc. announced recently that it will be expanding its existing research partnership with the University of Calgary. In order to develop and validate the next generation of medically relevant wearable monitors, the focus of the new partnership will be on areas beyond cardiac medicine, including fetal monitoring and sleep apnea.

Medtronic plc is the first company to receive U.S. Food and Drug Administration (FDA) approval for its suite of cardiac rhythm and heart failure devices and leads to be scanned in both 3 and 1.5 Tesla (T) magnetic resonance imaging (MRI) machines. This advancement gives patients with Medtronic SureScan MR-conditional pacemakers, implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy-defibrillators (CRT-Ds) and leads access to MRI scans on any part of the body.

A surveillance project to evaluate the safety and effectiveness of transcarotid artery revascularization (TCAR) in comparison with carotid endarterectomy (CEA) is being launched by the Society for Vascular Surgery Patient Safety Organization (SVS PSO). Carotid artery stenting (CAS) and CEA are performed in patients with atherosclerotic narrowing of the carotid artery in order to reduce stroke risk.

SentreHeart Inc. announced this week it has treated the first patients using the Eclipse Surgical Device, which is approved and CE Marked in Europe for left atrial appendage (LAA) closure. Krzysztof Bartus, M.D., Ph.D., and associate professor of the Jagiellonian University, Department of Cardiovascular and Transplant Surgery in Krakow, Poland performed the procedures.

3-D bioprinting, 3-D printing, printed organs, 3D bioprinting
3-D bioprinting, 3-D printing, printed organs

The U.S. Food and Drug Administration (FDA) changed its rules concerning custom medical devices Oct. 12, adding new definitions to better outline what constitutes a device that does not require premarket or 510(k) marketed clearances, or requirements for clinical trials to measure its efficacy or safety. The FDA also released a guidance document for manufacturers and FDA staff regarding these amendments. The FDA made the changes as these types of devices are being eyed for guidance in the creation of custom, one-off, 3-D printed medical devices. 

VIVA (Vascular Interventional Advances) Physicians announced a number of highly anticipated late-breaking clinical trial results at VIVA 16, hosted at the Wynn Las Vegas Sept. 18-22.

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