Trends & Technology

A National Institutes of Health (NIH)-supported study found that cardiovascular-related deaths have declined over the past two decades, but disparities remain. Inequities are mostly driven by differences in race and ethnicity, geographic location, and access to care, among other factors. The findings, recently published in Circulation (Circulation July 2022), reviewed three papers. Each paper – published by the Centers for Disease Control and Prevention (CDC) and the Multi-Ethnic Study of Atherosclerosis (MESA) – discussed data surrounding cardiovascular disease-related deaths in the U.S. Two of these three papers specifically focused on the racial and ethnic disparities presented within these datasets, while the third focused on climate, specifically temperature, as a factor in cardiovascular-related deaths.

Adjusting their study of overall and cardiovascular deaths among Black, white, Hispanic, and Asian Americans, researchers considered other attributes to these deaths, including social, lifestyle, and clinical factors. They found that older adults, men, and Black adults were most likely to experience cardiovascular-related deaths. “Multiple factors can independently and synergistically influence cardiovascular health,” said Nicole Redmond, MD, PhD, MPH, Chief of the Clinical Applications and Prevention Branch in the Division of Cardiovascular Sciences of the National Heart, Lung, and Blood Institute. “Further study of the intersection of environmental, social, behavioral, and clinical risk factors and potential interventions are needed to mitigate these risks and close the equity gap.”

Coronavirus (COVID-19) update: FDA authorizes emergency use of Novavax COVID-19 Vaccine, Adjuvanted

The U.S. Food and Drug Administration (FDA) recently approved the emergency use of the Novavax COVID-19 Vaccine, Adjuvanted in individuals 18 years or older. The FDA determined that the Novavax COVID-19 Vaccine, Adjuvanted has met the statutory criteria for issuance of an emergency use authorization (EUA) in July 2022. The vaccine contains the SARS-CoV-2 spike protein and Matrix-M adjuvant (adjuvants are incorporated into some vaccines to enhance the immune response of vaccinated individuals). When administered as a two-dose primary series, three weeks apart, the Novavax COVID-19 Vaccine is believed to be effective in preventing COVID-19.

The vaccine was assessed in an ongoing randomized, blinded, placebo-controlled study. Among these participants, approximately 17,200 received the vaccine and approximately 8,300 received saline placebo. Overall, the vaccine was 90.4% effective in preventing mild, moderate, or severe COVID-19. Vaccine safety was assessed in approximately 26,000 clinical trial participants who received the vaccine and approximately 25,000 who received placebo. The most commonly reported side effects included pain/tenderness, redness and swelling at the injection site, fatigue, muscle pain, headache, joint pain, nausea/vomiting, and fever.

Genixus™ Introduces Propofol as the First Product to be Delivered Within KinetiX™ Ready-to-Administer (RTA) Syringe Platform

Genixus™, a pharmaceutical company focused on transforming acute and critical care medicines, today announced that it will offer Propofol as the first product within its KinetiX™ platform of RTA syringe products at the Annual National Pharmacy Purchasing Association Conference (booth # 603-605).

“Following the recent 503B registration and licensing of our facility in North Carolina, Genixus is excited to deliver an RTA format of Propofol, one of the most commonly used medications within the OR setting” said Seth Coombs, Co-Founder & Chief Commercial Officer of Genixus. “Our KinetiX platform is designed to deliver clinical tools that seamlessly integrate into the operations of the acute and critical care setting, allowing clinicians to focus on their ultimate goal: the quality of care and patient outcomes.”

The new Propofol Syringe is the first product to be available within the KinetiX RTA platform, which is designed to simplify workflow and support effective care delivery. To support error resistance and clinical efficiency, KinetiX Propofol features several key attributes:

• Long-term shelf stability
• ISMP™-driven label
• Color-coded plunger rod
• Auto-dispensing cabinet (ADC) ready
• RFID-enabled
• 10mL and 20mL formats

“The new KinetiX RTA platform will support error resistance for our patients by addressing the risk of vial and syringe swap medication errors as well as the risk of contamination when drawing medication out of a vial,” said Jason Erlich, MD, anesthesiologist in Boston, Massachusetts, and advisor to Genixus.

Interferon treatment may reduce severity of COVID-19 in people with certain genetic factors

Building on previous studies that have already begun exploring the link between genetic variants affecting OAS antiviral proteins and the SARS-CoV-2 virus, researchers at the National Cancer Institute (NCI) have found that people of European and African ancestries, who were hospitalized after contracting COVID-19, were found to be more likely to carry a particular combination of genetic variants in a gene known as OAS1 than patients with mild disease who were not hospitalized. People with this combination of genetic variants also remain positive for SARS-CoV-2 infection longer. However, interferon treatment may reduce the severity of COVID-19 in people with these genetic factors. Interferons are a type of protein that can help the body’s immune system fight infection and other diseases such as cancer.

The NCI researchers and their collaborators found that treatment of cells with an interferon decreased the viral load of COVID-19. Along with this finding, the researchers also analyzed data from a clinical trial in which patients with COVID-19 who were not hospitalized were treated with the recombinant interferon pegIFN-λ1 and found that treatment improved viral clearance in all patients. However, those with the OAS1 risk variants benefitted the most. The results suggest that interferon treatment may improve COVID-19 outcomes – but specifically, this treatment option is extraordinarily beneficial in patients with certain OAS1 genetic variants who have an impaired ability to clear infection.

FDA releases action plan for rare neurodegenerative diseases, including ALS

Recently, the FDA released its five-year Action Plan for Rare Neurodegenerative Diseases, including amyotrophic lateral sclerosis (ALS) (asamonitor.pub/3CbAth4), a strategy for improving and extending the lives of people living with rare neurodegenerative diseases. The FDA hopes to achieve this goal by advancing the development of safe and effective medical products and facilitating patient access to novel treatments. The FDA’s new plan will focus on bolstering scientific advancement and promoting innovation for rare neurodegenerative diseases by engaging in targeted activities, such as establishing the FDA Rare Neurodegenerative Diseases Task Force (FY 2022), establishing the public-private partnership for rare neurodegenerative diseases (FY 22), developing disease-specific science strategies (FY 22-FY 26), and leveraging ongoing FDA regulatory science efforts.

Another element of this plan is the ALS Science Strategy, which will focus specifically on ALS by providing a forward-leaning framework for FDA activities to assess key regulatory science priorities. This will include improving characterization of disease pathogenesis and natural history, facilitating patient access to new drugs whenever possible and promoting greater participation in clinical trials, and enhancing clinical trial infrastructure and agility. Successful implementation of this crucial strategy will require patient engagement, public workshops, research projects, coordination across FDA centers and offices, and collaboration with the National Institutes of Health.

Technology

Abbott has announced that the FDA has granted a Breakthrough Device designation to investigate the use of its deep brain stimulation (DBS) system in treatment-resistant depression (TRD), a form of major depressive disorder. Breakthrough Device designations are awarded to medical devices believed to have the potential to provide more effective treatments or diagnosis for life-threatening and/or irreversibly debilitating diseases. Abbott’s deep brain stimulation therapy involves the implantation of thin wires – or leads – into targeted areas of the brain. Then, a pulse generator is implanted under the skin of the chest. Connected to the leads in the brain, it produces electrical impulses that can modulate abnormal brain activity. The device was traditionally used to help control symptoms of movement disorders such as Parkinson’s disease and essential tremor. However, evidence suggests that implanting electrodes in the part of the brain that regulates mood could help reduce symptoms of treatment-resistant depression. Currently, Abbott is working on developing a plan with the FDA to evaluate the device’s safety and effectiveness for this purpose.

Late-breaking data reinforce broad range of patient benefit from Abbott’s mitral and tricuspid heart valve devices

Late-breaking data related to Abbott’s MitraClip™ and TriClip™ was announced in early June 2022. The MitraClip™ being the world’s first transcatheter edge-to-edge repair (TEER) device, while the TriClip™ is a first-of-its kind minimally invasive tricuspid heart valve repair device. The data – found during the MitraClip EXPAND, TRILUMINATE and bRIGHT TriClip studies – has reinforced the capabilities of Abbott’s structural heart solutions for both mitral and tricuspid regurgitation (MR and TR) across a broad range of patient groups battling leaky heart valves. After one year, data collected across all patient groups participating in the global MitraClip EXPAND Study has shown significant MR reduction to ≤1+ MR (81.3%-97.2%), improvements in New York Heart Association (NYHA) class (a classification of functional limitations resulting from cardiac disease) and quality of life from baseline, and comparable all-cause mortality and heart failure hospitalization rates. The 30-day results of the TriClip and TriClip G4 TEER systems studies found that, in patients with TR and a pacemaker lead across the tricuspid valve, there was a high rate of implant (98%) and acute procedural (91%) success, at least a two-grade TR reduction in 64% of patients, and life-changing clinical improvements, including 69% of patients achieving NYHA Functional Class I/II.

Cook Medical launches MINC+™ Benchtop Incubator for IVF clinics in the US and Canada

In May 2022, Cook Medical launched MINC+™, the newest generation of the MINC^® Mini Incubator, a benchtop incubator that has been a standard component in IVF clinics for more than 20 years. The DishTrace platform, which combines functionality through the incubator touchscreen and a PC software program to provide a wide range of dish-data management tools, is also incorporated into this new incubation system. This platform will allow users to access and log information via the touchscreen, track culture dishes as they are checked in and out of the incubator, monitor up to 50 MINC+ incubators, and generate and view graphical histories and reports of MINC+ activity.