Integer Supports Respicardia’s Commercialization in Central Sleep Apnea Market Through New Agreements

Integer, a leading medical device outsource manufacturer, has entered into a new development agreement and a new supply agreement with Respicardia Inc. Under the agreements, Integer will be Respicardia’s development partner and majority supplier of the remedē implantable pulse generator (IPG) and related products for 7 years, the first 5 ½ years as an exclusive supplier.

“We’re honored to continue supporting Respicardia in bringing their therapy to market,” says Tony Gonzalez, president of Integer’s Cardiac Rhythm Management and Neuromodulation product line, in a release. “We supported their initial system development as they worked through their clinical studies, so it’s exciting to see their transition to commercialization. These agreements highlight Integer’s breadth of capabilities to support customers with design, development, and manufacturing of custom IPG systems. Our end-to-end expertise will help Respicardia ensure the utmost quality and reliability of their products.”

Peter Sommerness, president and CEO of Respicardia, says, “In product innovation, quality, and uncompromising clinical performance, Integer-manufactured devices are second-to-none. Integer is recognized as an innovative company that shares our vision to improve patient quality of life and overall health. Respicardia sought a partner with the ability to scale the production to meet the market needs of our unique therapies.”

Respicardia’s remedē System is a transvenous neurostimulation device that treats moderate to severe central sleep apnea in adult patients. CSA results from the brain’s failure to send appropriate signals to the respiratory muscles to stimulate breathing.

from Sleep Review http://www.sleepreviewmag.com/2019/01/integer-respicardia-commercialization-central-sleep-apnea-market-new-agreements/…

Blue Cross of Idaho Issues Positive Coverage Policy of Inspire Therapy

Blue Cross of Idaho has issued a positive coverage policy of Inspire Medical Systems Inc’s Inspire upper airway stimulation therapy for obstructive sleep apnea. This is the first coverage policy issued following BCBS Evidence Street’s January 7, 2019 report, which stated there is sufficient evidence to determine that Inspire therapy results in a meaningful improvement in net health outcomes for patients meeting specified criteria.

Blue Cross of Idaho is a not-for-profit mutual insurance company covering approximately 500,000 members. Blue Cross of Idaho is an independent licensee of the Blue Cross and Blue Shield Association (BCBSA). The Blue Cross of Idaho policy is effective March 20, 2019. This policy has a few changes from the Evidence Street summary including a BMI of less than 32. This Blue Cross of Idaho is the first policy to include coverage for adolescents who have Down’s syndrome. It is important to note that this indication is not yet approved by the FDA.

In addition to Blue Cross of Idaho, an additional positive coverage policy became effective January 1, 2019 with Ascension Smart Health. These positive coverage decisions are a result of the large and growing body of clinical evidence supporting the use of Inspire therapy for the treatment of moderate to severe obstructive sleep apnea.

Ascension Smart Health is the self-funded medical plan offered to associates of select Ascension entities and their eligible dependents. Ascension is the largest non-profit health system in the United

Blue Cross of Idaho Issues Positive Coverage Policy of Inspire Therapy

Blue Cross of Idaho has issued a positive coverage policy of Inspire Medical Systems Inc’s Inspire upper airway stimulation therapy for obstructive sleep apnea. This is the first coverage policy issued following BCBS Evidence Street’s January 7, 2019 report, which stated there is sufficient evidence to determine that Inspire therapy results in a meaningful improvement in net health outcomes for patients meeting specified criteria.

Blue Cross of Idaho is a not-for-profit mutual insurance company covering approximately 500,000 members. Blue Cross of Idaho is an independent licensee of the Blue Cross and Blue Shield Association (BCBSA). The Blue Cross of Idaho policy is effective March 20, 2019. This policy has a few changes from the Evidence Street summary including a BMI of less than 32. This Blue Cross of Idaho is the first policy to include coverage for adolescents who have Down’s syndrome. It is important to note that this indication is not yet approved by the FDA.

In addition to Blue Cross of Idaho, an additional positive coverage policy became effective January 1, 2019 with Ascension Smart Health. These positive coverage decisions are a result of the large and growing body of clinical evidence supporting the use of Inspire therapy for the treatment of moderate to severe obstructive sleep apnea.

Ascension Smart Health is the self-funded medical plan offered to associates of select Ascension entities and their eligible dependents. Ascension is the largest non-profit health system in the United

Sleeping Less Than 6 Hours May Increase Cardiovascular Risk

People who sleep less than 6 hours a night may be at increased risk of cardiovascular disease compared with those who sleep between 7 and 8 hours, suggests a new study published in the Journal of the American College of Cardiology. Poor quality sleep increases the risk of atherosclerosis—plaque buildup in the arteries throughout the body—according to the study.

“Cardiovascular disease is a major global problem, and we are preventing and treating it using several approaches, including pharmaceuticals, physical activity, and diet. But this study emphasizes we have to include sleep as one of the weapons we use to fight heart disease—a factor we are compromising every day,” says senior study author José M. Ordovás, PhD, researcher at the Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC) in Madrid and director of nutrition and genomics at the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, in a release. “This is the first study to show that objectively measured sleep is independently associated with atherosclerosis throughout the body, not just in the heart.”

Previous studies have shown that lack of sleep raises the risk of cardiovascular disease by increasing heart disease risk factors such as glucose levels, blood pressure, inflammation, and obesity, he says.

The new study included 3,974 bank employees in Spain from the PESA CNIC- Santander Study, led by JACC editor-in-chief Valentin Fuster, MD, PhD, which uses imaging techniques to detect the prevalence and

Sleeping Less Than 6 Hours May Increase Cardiovascular Risk

People who sleep less than 6 hours a night may be at increased risk of cardiovascular disease compared with those who sleep between 7 and 8 hours, suggests a new study published in the Journal of the American College of Cardiology. Poor quality sleep increases the risk of atherosclerosis—plaque buildup in the arteries throughout the body—according to the study.

“Cardiovascular disease is a major global problem, and we are preventing and treating it using several approaches, including pharmaceuticals, physical activity, and diet. But this study emphasizes we have to include sleep as one of the weapons we use to fight heart disease—a factor we are compromising every day,” says senior study author José M. Ordovás, PhD, researcher at the Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC) in Madrid and director of nutrition and genomics at the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, in a release. “This is the first study to show that objectively measured sleep is independently associated with atherosclerosis throughout the body, not just in the heart.”

Previous studies have shown that lack of sleep raises the risk of cardiovascular disease by increasing heart disease risk factors such as glucose levels, blood pressure, inflammation, and obesity, he says.

The new study included 3,974 bank employees in Spain from the PESA CNIC- Santander Study, led by JACC editor-in-chief Valentin Fuster, MD, PhD, which uses imaging techniques to detect the prevalence and

Front-loaded to a Fault?

Obstructive sleep apnea is a chronic condition, yet many clinicians and patients focus on the first 90 days. Some stakeholders envision years-long followup that considers the dynamic nature of the sleep disorder.

The vast majority of obstructive sleep apnea (OSA) cases require a lifetime of management to control—similar to other chronic disorders such as hypertension and diabetes. But the care pathway for many OSA patients more closely resembles that of people with surgical diseases such as appendicitis or cataracts: A flurry of activity until diagnosis, a sense of urgency to implement a therapy, then short-term followup.

Sleep apnea care focuses on the first 90 days. This is a reflection of factors such as payor requirements (notably, Medicare’s CPAP compliance guideline stating it won’t pay for continued therapy without adherence in that time frame), studies showing patients’ initial therapy usage informs later usage, and time constraints on sleep professionals.

But the emphasis on those first 90 days coupled with less focus on optimizing long-term care has its consequences. Some patients are shortchanged of lifelong symptom abatement and comorbidity management, particularly if they lose motivation to continue with therapy, their disorder becomes more severe, or they also have one of the many other disorders linked to sleep apnea.

“It has been well described in the literature that adherence to CPAP slowly wanes over time,” says Sanjay R. Patel, MD, MS, professor of medicine at the University of Pittsburgh and

New UNC Medical School Introduces Future Doctors to Sleep Medicine Early

An observant sleep medicine physician approached the school with a pitch: expose third- and fourth-year students to the sleep subspecialty.

Medical school curriculums generally don’t take a deep dive into sleep medicine. Some medical students may not even realize they have the option to subspecialize in sleep. This gap in education may be fueling a shortage of sleep medicine physicians.

Some medical schools are taking steps to change that. The University of North Carolina (UNC) in Ashville, NC, recently appointed Muhammad Sayed, MD, RST, RPSGT, to develop a sleep medicine curriculum in his new role as an assistant professor.

Through this program, third- and fourth-year students will have the opportunity to do rotations at the Charles George VA Medical Center in Asheville, NC, part of the US Department of Veterans Affairs. This is where Sayed will continue to work as chief of sleep medicine while he supervises the UNC program.

Sayed will spend time working one-on-one with students and giving lectures on campus. He hopes that through this initiative more future physicians will be exposed to and become interested in this area of medicine that is so crucial to overall health.

“It’s known here in the US that medical students and even residents, in general, don’t get enough education in sleep medicine, if any. They get this education only when they start doing a fellowship in sleep medicine,” says Sayed. “I think we really need to expand

The Oral Sleep Appliance Patient Treatment Journey

A Diplomate walks those less familiar with the process step-by-step through oral appliance therapy.

Oral appliance therapy (OAT) provides an alternative treatment option for those with upper airway resistance syndrome and obstructive sleep apnea (OSA). The patient’s treatment journey begins with the referring physician, who will have administered a sleep test, and, either due to the patient’s noncompliance with CPAP or the patient’s preference, sends the patient to a dental sleep medicine practitioner for an oral appliance.

The dentist’s job in properly treating a sleep apnea patient with an oral appliance involves a set of processes that are undertaken with the goal of identifying the patient’s specific needs, the condition of their mouth and throat, and their systemic health. Once the patient has been thoroughly evaluated, the appropriate device can be selected and fitted, allowing the patient to begin their treatment and follow-up.

Outlined here is the standard process used in my office to guide the patient from initial consultation to successful treatment. While each dentist runs their office slightly differently, this patient journey is usually followed with the goal of selecting the appropriate appliance and treating the patient’s OSA long-term.

The Initial Appointment

In this appointment, the sleep test is reviewed and interpreted to confirm the patient’s suitability for oral appliance therapy. Disqualifiers for OAT include those with a physical condition that would make it extremely uncomfortable for the patient to wear an

How To Recover Lost Sleep

With everything the world can offer right now, what most people are longing for the most is sleep. Millions are losing sleep each day (or night, rather) because of conditions like sleep apnea or maybe by their own choice. Unhealthy lifestyle, poor diet, lack of exercise, preoccupation with gadgets, etc. are just some of the reasons why a lot of people are wide awake when they should be fast asleep already. But the damage has been done. You are already doing your body a lot of harm by neglecting to sleep so that your body can recuperate and recharge in preparation for activities for the next day.

It is worse if you put snoring in the equation because not only does the snorer suffer from breathlessness or their bodies losing sleep or oxygen but their spouses likewise have to endure this annoying habit that also affects their sleep quite negatively. Sleep deprivations lead to daytime sleepiness and mood swings that can easily take your day down the drain and even make you more prone to accidents as you lose focus and attention from the lack of sleep. The snorers, on the other hand, can experience a thickening of their arteries making blood circulation even more difficult. If this goes on for a long time, your health is compromised and your lifetime shortened too.

So, just like other maladies, the scale and management of the problem are wholly dependant on the

Do You Have The Winter Blues Or Seasonal Affective Disorder?

Many of us experience a change in mood during the cold, dark winter months and it’s not uncommon for people to shout about having the winter blues. Winter blues are very common with people reporting feelings of lethargy and gloomier moods. But winter blues shouldn’t impact your ability to enjoy life. What causes winter blue/seasonal […]

The post Do You Have The Winter Blues Or Seasonal Affective Disorder? appeared first on The Sleep Council.

from The Sleep Council https://sleepcouncil.org.uk/do-you-have-the-winter-blues-or-seasonal-affective-disorder/…