Medtronic is issuing a software update to address a safety risk caused by cybersecurity vulnerabilities associated with the internet connection between the Carelink 2090 and Carelink Encore 29901 programmers used to download software from the Medtronic software distribution network (SDN) . This update is a voluntary recall correction by the manufacturer to address the safety risk caused by the cybersecurity vulnerability.

October 17, 2018 — The U.S. Food and Drug Administration (FDA) has reviewed information about potential cybersecurity vulnerabilities associated with the internet connection of Medtronic's cardiac implantable electrophysiology device (CIED) programmers. The FDA said it has confirmed that these vulnerabilities could allow an unauthorized user to change the programmer's functionality or the implanted EP device during the device implantation procedure or during follow-up visits.

October 17, 2018 — The U.S. Food and Drug Administration (FDA) has cleared an additional indication for rivaroxaban (Xarelto) to reduce the risk of major cardiovascular (CV) events, such as CV death, myocardial infarction (MI) and stroke, in people with chronic coronary or peripheral artery disease (CAD/PAD). The drug is now the first and only factor Xa inhibitor approved for patients living with these conditions. The drug is made by The Janssen Pharmaceutical Companies of Johnson and Johnson. 

October 16, 2018 — Abbott announced that its High Sensitive Troponin-I blood test has received CE Mark for distribution in Europe. It is the first troponin test with CE Mark that can more accurately predict the chances of having a heart attack or other cardiac event potentially months to years in advance in people who otherwise appear healthy.

A new study published in the European Heart Journal shows computed tomography (CT) can be a useful aid in heart team decision-making for complex coronary disease. Results also suggest the state-of-the-art imaging technology may offer a non-invasive diagnostic alternative to conventional coronary angiography. Coronary artery disease (CAD) and its complications are a leading cause of death throughout the world. According to therapeutic guidelines, left main or three vessel diseases represent the most severe, high-risk CAD cases, often requiring coronary bypass graft surgery (CABG) or percutaneous coronary intervention (PCI) as treatment.

There is a hype cycle surrounding new technologies in all industries, but medicine is unique because of its focus on clinical trial data as one of the key determining factors of whether a new device becomes standard of care or dies on the vine. Here is a great summary of this cycle with cardiovascular devices.

Most professional athletes participate in cardiovascular screening to identify often-asymptomatic heart disorders, but the debate continues on whether to mandate ECGs as part of pre-participation screening for student athletes. Photo courtesy of Play for Patrick.

Sudden cardiac death (SCD) is the leading medical cause of death in young athletes and its impact is consistent worldwide.  Most professional athletes in the United States are required to take part in comprehensive cardiovascular screening programs to identify often-asymptomatic congenital or inherited heart disorders, and other cardiac risk factors. There remains a debate however, whether to mandate ECGs as part of pre-participation screening programs for student athletes at the collegiate and high school levels or even at younger ages.

From a cardiovascular device innovation standpoint, the 2018 Transcatheter Cardiovascular Therapeutics (TCT) conference included several noteworthy trial presentations. Here are a few of the key takeaways.

Most Innovative New Technologies at TCT 2018

The nation’s two leading cardiac accreditation and certification organizations are joining forces to offer a single joint product for hospitals beginning Jan. 1, 2019. The American Heart Association and The Joint Commission, the largest standards-setting and accrediting body in healthcare, are collaborating to enhance cardiovascular patient care and improve outcomes and quality of life for patients with cardiovascular disease.

Computed tomography (CT)-based measures of calcification in the abdominal aorta are strong predictors of heart attacks and other adverse cardiovascular events — stronger even than the widely used Framingham risk score. These assertions are according to a new study published in the journal Radiology.

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