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Attune Medical Major Milestones: Including ensoETM in Cardiac Ablation Procedures Published Study and $4 Mil Convertible Note Closing

Dr. Mark Gallagher (St. George’s University Hospital, London UK) evaluated the use of the ensoETM in cardiac ablation procedures to ascertain whether using the esophageal space for temperature management could have the potential to decrease collateral thermal injury related to radio-frequency (RF) ablation for the treatment of atrial fibrillation.

Signia Introduces World’s First ‘Face Mask Mode’ for Hearing Devices: Improves Audibility for Those Communicating with Someone Wearing a Face Covering & No More Lip Reading

“The hearing challenges presented by face masks became obvious pretty quickly into the pandemic, so Signia developed the first-of-its-kind Face Mask Mode to help those with hearing loss better communicate in this new reality,” said Tish Ramirez, Au.D. of Signia. “When this setting is activated, the hearing aids optimally capture the sound of the speech signals, enabling the words to sound clearer and reducing any background noise to help the wearer understand what is being said.” 

Modulim Announces CE Mark of Clarifi Imaging System for Microvascular Assessment

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Genius AI Detection Receives FDA Clearance

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New Landmark Study Published Online in Annals of Internal Medicine Show Bariatric Surgery Reduces or Eliminates Need for BP Medication in Obesity Patients in a 3 Year RCT

Patients with mild to moderate obesity who underwent bariatric surgery kept their blood pressure under control and required fewer or no medications compared to patients on standard medical therapy, according to a new landmark study published online in Annals of Internal Medicine.

GATEWAY*, a three-year study funded by a grant from Ethicon**, part of Johnson & Johnson Medical Devices Companies***, is the first randomized clinical trial to compare the effectiveness of these two interventions for the treatment of hypertension. Early results from the GATEWAY study, first published in 2018 in the medical journal Circulation,[i] showed similar results.

In the new three-year study, nearly three-quarters (73%) of gastric bypass patients were able to stop taking 30% or more of their antihypertensive medications and still maintain a blood pressure of less than 140/90 mm Hg, the study’s primary endpoint. Only 11% of those on standard medical therapy alone were able to do the same over the three-year follow-up period.

Notably, while 35% of bariatric surgery patients achieved remission of their hypertension without the need for continued medication, only 2% of patients on medical therapy ever did. No patients in the medical therapy group achieved a blood pressure lower than 130/80 mm Hg, a target achieved by 31% of gastric bypass patients. In addition, patients on drug therapy experienced a modest weight gain compared to surgical patients who on average lost 27.8% of their total body weight.

“The latest GATEWAY results showed that early improvements and even remission of high blood pressure in bariatric surgery patients are sustainable over a longer period of time while those on conventional medical treatment continue to face difficulties with both hypertension and obesity,” said lead study investigator Carlos Aurelio Schiavon, MD,^ a bariatric surgeon at Hospital do Coracão (HCor) in Brazil, the center where the trial was conducted. “This new high-level evidence should be factored into the treatment recommendations of cardiologists and primary care doctors who care for patients with obesity and hypertension.”

The single center randomized study included 100 patients all of whom had obesity (BMI between 30.0 and 39.9 kg/m2) and were taking at least two blood pressure medications at maximum doses or more than two medications at moderate doses.

Nearly half the adults in the United States (108 million, or 45%) have hypertension[ii] and 42.4% have obesity,[iii] which are independent risk factors for heart disease and stroke, leading causes of death.[iv] When a patient has both conditions, the risk of cardiovascular mortality may nearly double.[v] The Centers for Disease Control and Prevention (CDC) reports that only about 1 in 4 adults (24%) with high blood pressure have it under control.3

“Bariatric surgery is the most effective and durable treatment for the disease of obesity and GATEWAY adds to the mounting body of high-level evidence that shows its benefits extend far beyond weight loss,” said Raymond Fryrear, MD, VP & Integrated Leader, Pre-Clinical, Clinical and Medical Affairs, Ethicon, Inc. “Randomized clinical trials remain the cornerstone of evidence-based medicine and Ethicon continues to invest in these studies in support of the global medical community and patients who could benefit from this surgical option.”

Three landmark randomized clinical trials – MOMS[vi], STAMPEDE[vii] and most recently GATEWAY – all sponsored by Ethicon in the last few years – have helped to further establish bariatric and metabolic surgery as a highly effective treatment option for type 2 diabetes, early chronic kidney disease and hypertension in patients with obesity. While previous studies have resulted in similar findings, none were randomized clinical trials, considered the “gold standard” for research because they produce the highest level of evidence in assessing the effectiveness of treatment.


References

[i] Schiavon CA, Bersch-Ferreira AC, Santucci EV, et al. Effects of bariatric surgery in obese patients with hypertension: the GATEWAY randomized trial (Gastric bypass to treat obese patients with steady hypertension). Circulation. 2018;137:1132-1142. [PMID: 29133606] doi:10.1161/CIRCULATIONAHA.117.032130

[ii] https://www.cdc.gov/bloodpressure/facts.htm

[iii] https://www.cdc.gov/nchs/products/databriefs/db360.htm#ref1

[iv] Mozaffarian D, et. al. on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics— 2015 update: a report from the American Heart Association [published online ahead of print December 17,

2014]. Circulation. doi: 10.1161/CIR.0000000000000152. Accessed from http://circ.ahajournals.org/content/131/4/e29

[v]  Landsberg et al. Obesity Related Hypertension. The Journal of Clinical Hypertension. Figure 2. http://onlinelibrary.wiley.com/doi/10.1111/jch.12049/epdf

[vi] https://jamanetwork.com/journals/jamasurgery/article-abstract/2766660

[vii] http://www.nejm.org/doi/full/10.1056/NEJMoa1600869

 

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