A Digital Publication for the Practicing Medical Specialist, Industry Executive & Investor

Pilot Study Underway to Investigate Use of Attune Medical’s ensoETM for COVID-19 Treatment

A pilot study using Attune Medical’s ensoETM, a thermal regulating device, has begun enrollment in the first study to evaluate the impact of core warming on the length and severity of illness in hospitalized patients with COVID-19. The randomized, single-center pilot study, Core Warming of COVID-19 Patients Undergoing Mechanical Ventilation, is being conducted by physicians at Sharp Memorial Hospital in San Diego, California, and will investigate whether core warming can improve the recovery of patients diagnosed with COVID-19 and decrease their time spent on mechanical ventilation (breathing support).

There is growing evidence that fever, in general, may be beneficial, and that elevated body temperature enhances immune function while impeding the activity of many pathogens, including a wide range of viruses. The SARS-CoV-2 virus that causes COVID-19 may be particularly temperature-sensitive, and elevated body temperatures could negatively impact its ability to enter cells.

In the most critically ill patients with COVID-19, however, fever is often absent. This pilot study will examine whether proactively increasing core temperature in critically ill patients that require breathing support will reduce patients’ viral load, decrease the duration of breathing support needed, and improve lung condition and survival. It will randomize a total of 20 patients diagnosed with COVID-19 on mechanical ventilation, half to standard care (no warming), the other half to treatment with core warming.

The study is led by a pulmonologist and critical care physician David Willms, MD, building off of work on external warming by Drs. Anne Drewry and Richard Hotchkiss at Washington University in St. Louis. It is thought that directly warming the patient’s core, where much of the viral damage occurs in the heart and lungs, may provide further benefits while avoiding the physiologic stress of skin and whole-body warming.

“There have been data suggesting the benefits of fever and of warming patients with infectious conditions for a long time, but to date, just one randomized controlled study has been performed to formally investigate this treatment option. We look forward to further advancing this important area of medicine with new technology, and potentially transforming the way we care for these critically ill patients,” said Dr. Willms.

Attune Medical’s ensoETM is a single-use thermal regulating device that is placed in the esophagus (similar to a standard orogastric tube) and connected to an external heat exchange unit, creating a closed-loop system for heat transfer to increase or decrease patient temperature. Its placement in the esophagus, with proximity to blood flow from the heart and great vessels, allows highly efficient heat transfer. Unlike surface warming devices, ensoETM‘s internal placement doesn’t impede patient access during surgery and allows gastric decompression and administration of fluids and medications.

“We are particularly passionate about research initiatives like this that could help improve patient outcomes,” commented Dr. Erik Kulstad, the inventor of the ensoETM and a practicing Emergency Medicine physician. “We see first-hand the devastating toll this disease is taking, and are grateful to have the chance to help make a difference.”

Attune Medical has developed a novel medical device technology that simplifies access to the patient’s core to efficiently control temperature and is the only device FDA-cleared for use in the esophagus for whole-body temperature management. The ensoETM device is used in critical care units, operating rooms, and emergency departments for the intentional modulation of patient core temperature and can be rapidly placed by most trained healthcare professionals.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

The Evolut ™ FX+ TAVR system leverages market-leading valve performance with addition of larger windows to facilitate coronary access
The study was an analysis of AstraZeneca’s Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF). The patient data from the trial was processed with Brainomix’s e-Lung tool. The tool is uniquely powered by the weighted reticulovascular score (WRVS), a novel biomarker that incorporates reticular opacities and vascular structures of the lung.
“Since the algorithm for matching patients with donors is changing across for all organs, this was a prime time to better understand whether transplant team decisions to accept a donated organ varied by patient race and gender,” she said. “We wanted to understand how the process of receiving a transplant after listing varied by race and gender, and the combination of the two, so that steps can be taken to make that process more equitable," said Khadijah Breathett, MD.
The Mount Sinai study found that primary care physicians’ approach reflects a dearth of evidence-based guidance for lung cancer screening shared decision-making in patients with complex comorbidities
This is the first ever transplantation of a genetically engineered porcine kidney into a living human recipient.

By using this website you agree to accept Medical Device News Magazine Privacy Policy