Abbott Laboratories received FDA clearance for its Freestyle Libre 3 continuous glucose monitoring system (CGM) just before the kickoff of the American Diabetes Association (ADA) annual meeting June 3 followed by breakthrough device designation for a combined CGM and continuous ketone monitoring system.
Abbott Laboratories reported results from its PERSIST-END study demonstrating that close to nine in 10 patients treated for persistent atrial fibrillation (AF) with its Tacticath contact force ablation, sensor-enabled (Tacticath SE) were free of symptoms of their arrhythmia over 15 months of follow-up. The study’s findings, which supported a November 2021 FDA approval for persistent AF, also showed significant improvement in patients’ quality of life and a more than 50% cut in the use of health care resources, the company said.
With one-quarter of China’s population affected by rolling shutdowns, manufacturers worldwide are preparing for a summer of supply chain nightmares. Shanghai and its normally bustling port have been closed now for a month and the nation’s COVID-Zero policy is now threatening Beijing. So far, though, the med-tech industry remains minimally affected, but the coming months may tell a different story.
While a number of companies cited continued supply chain issues in recent investor calls and earnings reports, few med-tech leaders have expressed concerns about serious disruption to operations or loss of revenue because of the destruction wrought by the invasion of Ukraine or the associated sanctions on Russia. Most companies derive less than 1% of their revenue from the two countries.
Though the Ukraine war has had an impact on the availability of medical devices and diagnostics, a number of companies based in the U.S. and Europe have announced measures to ensure their products will reach the war-torn nation. Device companies are donating millions to nongovernmental organizations for humanitarian assistance, while the Advanced Medical Technology Association (Advamed) said its member companies are tracking the situation and are eager to pitch in with desperately needed supplies and medical equipment.
Abbott Laboratories’ Cardiomems heart failure (HF) system is open to a larger patient population following an expanded approval from the FDA. Abbott’s system had previously been approved for class III HF patients that had been hospitalized for HF in the past year. A new expanded indication enables the sensor to be utilized by class II (earlier stage) HF patients and those whose blood test show elevated levels of biomarkers known as natriuretic peptides. The FDA based the approval on findings from the GUIDE-HF trial, which suggested class II HF patients and patients with elevated natriuretic peptides had better outcomes when their therapy was guided by pulmonary pressure monitoring, with a 34% and 25% reduction in heart failure hospitalizations and emergency visits, respectively, based on study data adjusted for the impact of COVID-19.
Abbott Laboratories reported the commencement of a pivotal clinical trial for its Aveir pacemaker in a two-device configuration to provide dual-chamber pacing without the need for leads to deliver the charge. This configuration required the development of i2i technology to ensure that the two Aveirs communicated in a manner that ensures consistent pacing, but the 500-enrollee study has a long road ahead of it before the company can finalize the application with the FDA.
Abbott Laboratories received FDA 510(k) clearance for the Ensite X EP system with Ensite omnipolar technology, the company’s cardiac mapping platform. The system, which is used to identify and treat abnormal heart rhythms such as atrial fibrillation, produces detailed three-dimensional maps of the heart to guide physicians performing ablation procedures.
Digital health innovation was front and center at this year’s Consumer Electronic Show (CES) in Las Vegas. The four-day event included a major product announcement from Abbott Laboratories and a keynote presentation delivered by CEO Robert Ford. This marked the first time a health care company has been invited to take the main stage.
Becton, Dickinson and Co. (BD) completed its acquisition of Scanwell Health Inc., its partner in development of the smartphone-enabled BD Veritor At-Home COVID-19 Test, just in time for increased demand driven by the Omicron surge in the U.S. and plans to make the tests available for free by the federal government as well as several states and large municipalities. Currently, most of the tests distributed by governments are made by Abbott Laboratories, which received emergency use authorization (EUA) for its at-home test in March 2021.
