Posts tagged with "FDA"

NasalGuard®

A Topical Gel that Reduces Inhalation of Harmful Airborne Contaminants Makes National Debut

Perfect for Flu and Cough Cold Season, Indoor Pollutants, Pet Allergies and More

Trutek Corp. announces the launch of NasalGuard®Airborne Particle Blocker®. NasalGuard is an electrostatic topical nasal gel that prevents airborne particles from entering the nose. The product is drug-free and safe for pregnant or nursing women, children, and those concerned about potential drug interactions with other medications. It is a perfect solution to guard you against the Flu/Cough/Cold and all indoor pollutants this winter season.

NasalGuard protects against virtually all types of contaminants in any location. Users can count on it to work in their homes, offices, and other environments where airborne particles may present a health hazard. The product works immediately upon application and lasts up to six hours. NasalGuard gel uses a cationic (positively-charged) polymer that creates a safe electrostatic field around the nasal passages that traps oppositely charged particles and repels similarly charged particles to reduce inhalation of most harmful airborne particles before they enter your body. NasalGuard gel can be purchased online, Amazon or by calling 855-627-2545 in a 3 gram tube for $11.85.

Every day, people are exposed to millions of airborne particles in crowded, confined spaces such as airports, airplanes, transportation centers and subways, homes and offices, hospitals, doctor’s offices and movie theaters. Using NasalGuard gel regularly will help protect against the immediate and long-term risk of breathing harmful contaminated air.

There has been a growing public health concern globally regarding the adverse health effects caused by the inhalation of microscopic airborne particles. Asthma, diabetes, lung cancer and cardiovascular disease are all proven to be linked to air contamination. In response to this widespread problem, Trutek has successfully advanced their technology which was originally focused on blocking allergens from entering the nose for preventing allergy symptoms. This breakthrough provides a greater electrostatic blocking effect that is effective against a much wider spectrum of microscopic indoor and outdoor contaminants including mold, pollen, pet dander, pollution, and virus-sized particles.

NasalGuard technology was invented by Ashok Wahi, the founder and CEO of Trutek Corp., an R&D Product Development Company. An engineer by training, Ashok was inspired to create this technology to aid his own daughter, Aikta, who suffered from severe allergies. “I developed this product because of the vital need to have some kind of personal air filter that was drug free and easy to use,” says Ashok Wahi.

About Trutek Corp.

Trutek Corp. has been marketing patented NasalGuard technology all over the world since 1995. Over 12 million tubes have been sold with no reports of adverse effects.

Follow us on Facebook @nasalguard

New AI app reduces back pain by 40%

Boston based digital therapy startup Kaia Health launches a new app that uses AI and patent pending motion tracking technologyto personalize treatment programs tomanage and treat chronic low back pain(LBP) which has been shown in clinical studies to reduce chronic back pain by 40% and could save the US economy billions each year.

Created by Kaia Health the motion tracking technology requires no additional hardware.The app has been registered as a Class 1 medical device with the FDA which allowsusers to self-manage their back pain through physical exercise, behavioural exercise (e.g. relaxation and meditation) and education.

Earlier this year the digital therapy startup launched the Perfect Squat Challenge App, the world’s first Artificial Intelligence-powered motion tracking fitness app that turns a smartphone into a personal trainer. In Q4 2018 the company intends to roll out20 more motion tracking exercises for the app.

According to the World Health Organization (WHO) LBP is the single leading cause of disability worldwide. In fact, according to the American Chiropractic Association(ACA) 31 million Americans experience LBP,and one half of all working Americans admit to having back pain symptoms each year.

The epidemic of prescription opioid overuse and abuse has also led many health groupsincluding the ACA, the American College of Physicians (ACP) and the American Association of Pain Management (AAPM) to reconsider the value of a non-pharmalogicalapproach to common conditions such asLBP.

The ACP, the largest medical specialty society in the world, updated its LBPtreatment guidelines in 2017 to support a conservative approach to care. Published in the Annals of Internal Medicine, and based on a review of randomized controlled trials and observational studies, the ACPguidelines cite heat therapy, massage, acupuncture and spinal manipulation (a centerpiece of chiropractic care) as possible options for non-invasive, non-drug therapies for LBP. The guidelines state that only when such treatments provide little or no relief should patients move on to medicines such as ibuprofen or muscle relaxants, which research indicates have limited pain relief effects. According to the ACP, prescription opioids should be a last resort for those suffering from LBP, as the risk of addiction and overdose may outweigh the benefits.

The Kaia app has been developed by aleading digital therapy company Kaia Health in conjunction with physiotherapists, pain management physicians and clinical psychologists.

The app uses a multidisciplinary digital approach which offers users online video-based learning programmes that covereducation, physiotherapy (includingexercises for the lower back and lateral muscles) and psychological strategies(including mindfulness and muscle relaxation).

The AI tailors treatment programs for each user from over 120 exercises, and motion tracking technology ensures that the exercises are performed correctly using a smartphone, tablet or iPad without the need for additional hardware.

Each session lasts for 15 minutes and can be accessed anywhere 24 hours a day. The app also features a chat function whichconnects users to a physiotherapist or sport scientist for motivation and exercise related questions.

Two clinical trials into the Kaia app show a significant reduction in LBP by 40%, well above the clinical threshold of pain improvement. The second study shows a40% long-term retention of users for aminimum of 6 months.

The Kaia app was developed in Germanywhere it has been downloaded over 100,000 times in its first year. The Kaia app is now being reimbursed for over 20 million patients globally.

Kaia Health is member of the Digital Therapeutics Alliance (DTA), an association of international manufacturers for digital therapeutic products that are evidence-based.

Konstantin Mehl, CEO of Kaia Health says:Opioid addiction and overdose is a huge issue in the US, and is, according to the ACP, a last resort for those suffering from LBP. Their 2017 LBP treatment guidelines support a non-pharmalogical approach to care using non-invasive, non-drug therapies. A holistic, multidisciplinary treatment of LBPhas always been a resource-intense, costlyundertaking which makes it hard forpatients to get access to the therapy.However, with the Kaia app we’re digitising therapy which offers as many patients as possible access to effective treatment ofLBP. This empowers and motivatesindividuals to take control, and self-manage their condition with evidenced-based, non-pharmacological, cost-effective alternatives and this could save the US economy billions each year. The Kaia app, and advances in technology, demonstrates why we need to rethink how we treat diseaseconditions such as LBP, and make digitalself-management a more realistic part of treatment.

The Kaia app is available on iOS and Android, and can be downloaded via GooglePlay and AppStore. The first 7 days of the program are free. To unlock the full functionality the costs are: 3 months: $23.99, 6 months: $64.99 and 12 months: $94.99.

About Kaia Health www.kaia-health.com
Founded in 2016, Kaia Health is a leading digital therapy company that creates evidence-based treatments for a range of disorders including back pain, Parkinson’s disease, osteoarthritis and chronic obstructive pulmonary disease. Kaia Health uses innovative technology including artificial intelligence and apps, and works with experts in each medical field to create an interdisciplinary digital approach. This empowers and motivates individuals to take control and self-manage their condition with effective, non-pharmacological, digital alternatives at low costs.

Cosmetic Surgery

In 2009, then Governor of California Arnold Schwarzenegger signed the Donda West Plastic Surgery Law, requiring health checks be conducted prior to all major plastic surgery procedures in the state. This was following the death of rapper Kanye West’s mother. It was later determined that her heart attack was spawned by a combination of numerous postoperative complications and pre-existing coronary artery disease. Today, women especially peruse Instagram and covet a perfect pout, perky derriere and firm breasts seen on Insta models. Just because you may desire cosmetic surgery does not mean you are physically or mentally fit for it NOW. Dr. Stanley Poulos is a board certified San Francisco area plastic surgeon who takes steps to ensure the health and safety of his patients during surgery and post- operatively. Here are some indicators Dr. Poulos looks for to assess patients for surgery.

Dr. Poulos stresses that it is essential for a surgeon to take a good medical history and exam of the patient. Current and past illnesses, especially cardiac or pulmonary problems, surgeries, and medications should all be discussed. Lab tests may be required on a case by case basis depending on patient history and planned procedures.

Urinalysis

When it comes to preparation for a plastic or cosmetic surgery procedure, a urinalysis can inform the doctor if you have certain types of infections, like a urinary tract (UTI), bladder, or kidney infection. Urine tests are also effective in detecting high blood pressure and diabetes.

Blood Count Test

Also known as a complete blood count (CBC), this blood test literally counts your blood. It takes note of the number of red blood cells, white blood cells, and platelets. This tells physicians if you’re anemic (red blood cell deficiency) or have a blood clotting disorder like hemophilia. CBC tests also detect infectious bloodborne diseases like HIV or hepatitis.

Heart function

Electrocardiogram (ECG or EKG)

Essentially, the ECG is a medical test that tells if your heart is in good condition through detecting any heart abnormalities by measuring the electrical activity of the heart when it contracts. Cosmetic surgery basically causes tremendous stress on the body, with the heart being one of the most important organs when it comes to stress response. That is why it is crucial for the doctor to assess whether your heart can endure the trauma during the operation.

Chest X-Ray

The Chest X-Ray is also one of the tests that may be required for your procedure. This is usually carried out to check the condition of your lungs and see whether you have breathing difficulties when you are put in anesthesia. This test is especially requested if you are a smoker or have a history of smoking. Signs of pneumonia or any breathing disorder may result to the postponement or cancellation of your surgery.

Smoking Use and History

Mixing nicotine with plastic surgery can result in problems:

Loss of cheek skin, nipples or tummy skin after a facelift, breast lift, breast reduction, or tummy tuck surgery

  • Infections
  • Death of fat cells (fat necrosis), causing hard lumps
  • Delayed wound healing
  • Thick, wide scars
  • Blood clots, which can be fatal
  • Increased pain
  • Permanent small vessel damage adding risk even if you quit
  • Loss of breast implants
  • Life-threatening complications like stroke, heart attack, blood clots, and pneumonia.

Mammogram

The mammogram is typically required for women who want to get breast augmentation or breast lift done. This is to help detect signs of breast cancer.

Psychological Screening

Although there is no formal psych test to assess a patient’s readiness and motives for cosmetic surgery, Dr. Poulos takes time with his patients to learn their reasons for desiring cosmetic change. Immediate red flags include, having surgery to try to keep a wayward spouse, an exaggerated concern over a minor problem, someone who seems addicted to cosmetic surgery, or a patient with body dysmorphic disorder. This syndrome is most appropriately treated by psychological treatment not surgical intervention.

Alcohol Habits

It is important not to drink alcohol before undergoing plastic surgery – or any type of surgery for that matter – as it can cause unforeseen complications and seriously impact final results and the way you heal. Alcohol, especially when consumed to excess, can dry out your skin, which can then result in cracks appearing. If you’re having a plastic surgery procedure where skin is stretched (facelift, breast augmentation or abdominoplasty for example) then dry, cracked skin will make it harder for the surgeon to staple or stich the skin together, resulting in a less than optimum result and possibly scar.

Body Weight

Sometimes patients will enter a plastic surgeon’s office excited about a decision to finally move forward with breast or body contouring surgery, but then afterwards emerge having found out they are not currently a candidate because of excess body fat. This scenario is not only disappointing, but it can be an emotionally deflating and potentially embarrassing experience for patients. Dr. Poulos sympathizes with the emotional pain that such patients feel, and he wants to help them realize their goals. However, there are several specific reasons that your plastic surgeon might recommend weight loss prior to undergoing a procedure. In addition, the results that you can achieve are likely to be much better if your weight is in a better range. Consider an overweight woman who wants breast reduction surgery. Even when the breasts become smaller and more uplifted, it is extremely difficult for us to deal with the fullness lateral to the breasts (the “bra roll”), which significantly compromises the aesthetic result. In addition, it is much harder to get a beautiful transition between the breast and the abdomen due to the excess weight. On the other hand, let’s consider the patient that is overweight and wants a tummy tuck or liposuction. In this instance, the surgeon will not be able to remove all the excess fat in these areas, as it is technically challenging and can look odd as it is out of proportion to the surrounding fatty deposits. Even large volume liposuction cannot fully solve this problem. Body contouring surgery is great for shaping your body, but it is not a method or substitute for weight loss or weight control. At Dr. Poulos’ clinic there is a full-time wellness/weight loss coordinator who helps patients achieve a healthy body composition ( body fat percentage and lean muscle mass balance) prior to undergoing body contour procedures.

What is an option for those who need to lose weight to be a better candidate for cosmetic surgery?

There is an FDA approved “Gastric Balloon” procedure that Dr. Poulos performs. It is appropriate for patients with a BMI of 30 to 40 that have not had previous weight loss surgery. Patients diagnosed with bulimia, binge eating, compulsive overeating, high liquid calorie intake habits or similar eating related psychological disorders are not good candidates. Dr. Poulos has now treated numerous patients who have successfully lost up to 20% of their body weight with the balloon procedures and have gone on to aesthetic body contouring with much improved results.

How does the balloon method work?

This non-surgical outpatient procedure begins with a diagnostic endoscopy to ensure that there are no contraindications and that it is safe to perform. Once the patient is mildly sedated and comfortable, the procedure can begin. The deflated gastric balloon is inserted through the esophagus and into the stomach. A syringe is then used to fill the balloon with a sterile saline solution. Once the weight loss balloon has been filled with saline, it expands to approximately the size of a grapefruit. The entire procedure takes about 20 minutes. Patients can usually return home after the placement or removal procedures within 30 minutes. Over the last 20 years this procedure has helped over 277,000 people. The gastric balloon encourages portion control while patients make healthy changes to diet and lifestyle.

How long does the balloon stay in place?

The balloon remains in the stomach for the first six months after the procedure. With the stomach balloon and Dr. Poulos’ support team, patients usually see the most drastic results in the first six months. It is very important to use this time to develop healthy habits that will continue for not only the 12-month weight loss program, but for the rest of one’s life.

What to expect after the balloon placement

Over the first 14 days after placement, patients may experience nausea or vomiting. Dr. Poulos recommends a liquid diet for his patients during the first week to help manage these symptoms. Also prescribed are effective anti-nausea drugs to help the patient through the initial stage.

How is the balloon removed?

Once the stomach balloon has been in place for six months the balloon is removed. The simple and non-surgical procedure is very similar to the placement process. Once the gastric balloon has been removed, it is very important to continue working closely with Dr. Poulos’ team and coaches to follow the personal diet and exercise plan provided. This will help to keep you in a positive and healthy mindset while achieving your weight loss goals.

About Dr. Stanley Poulos

Dr. Poulos specializes in cosmetic breast surgery and body contouring procedures. He helped pioneer the quick lift facial rejuvenation surgery in California and is recognized as one of the leading plastic surgeons in Marin County and the entire San Francisco Bay area. Dr. Poulos and Plastic Surgery Specialists have extensive experience in body contour procedures. A graduate of the University of Texas Medical School, Dr. Poulos completed his internship and residency at UC San Francisco. He completed a plastic surgery fellowship at St. Francis Hospital in San Francisco and is certified by the American Board of Plastic Surgery. www.psspecialists.com

NON-SURGICAL BALLOON WEIGHT LOSS METHOD

Americans spend almost 60 billion dollars annually in pursuit of weight loss with gastric bypass surgery being the most common type of weight-loss surgery; an option that isn’t for everyone. Like any major procedure, gastric bypass has significant health risks and side effects. In addition, to be a candidate for the procedure, one must have a BMI (body mass index) of 40 or higher. The fact is, a huge percentage of the population are only between 15 to 50 pounds overweight without any other options besides diet and exercise.  Dr. Stanley Poulos, a San Francisco board certified plastic surgeon is an early adaptor of the non -surgical balloon weight loss method approved by the FDA in 2016. Following the two-part program, patients lost an average 3.1x the weight compared with diet & exercise alone.

Dr. Poulos stresses that, “there is a direct correlation between those patients who stay connected to their program and their weight loss success.” Dr. Poulos is highly experienced in body contour plastic surgery which is sometimes required after major weight loss. Sometimes, due to skin laxity after weight loss, procedures such as thigh lift, breast lift, liposuction or “tummy tuck” are desired by patients.

Who is an ideal candidate for the balloon weight loss method?

It is appropriate for patients with a BMI of 30 to 40 that have not had previous weight loss surgery. Patients diagnosed with bulimia, binge eating, compulsive overeating, high liquid calorie intake habits or similar eating related psychological disorders are not good candidates.

How does the balloon method work?

This non-surgical outpatient procedure begins with a diagnostic endoscopy to ensure that there are no contraindications and that it is safe to perform. Once the patient is mildly sedated and comfortable, the procedure can begin. The deflated gastric balloon is inserted through the esophagus and into the stomach. A syringe is then used to fill the balloon with a sterile saline solution. Once the weight loss balloon has been filled with saline, it expands to approximately the size of a grapefruit. The entire procedure takes about 20 minutes. Patients can usually return home after the placement or removal procedures within 30 minutes. Over the last 20 years this procedure has helped over 277,000 people. The gastric balloon encourages portion control while patients make healthy changes to diet and lifestyle.

How long does the balloon stay in place?

The balloon remains in the stomach for the first six months after the procedure. With the stomach balloon and Dr. Poulos’ support team, patients usually see the most drastic results in the first six months. It is very important to use this time to develop healthy habits that will continue for not only the 12-month weight loss program, but for the rest of one’s life.

What to expect after the balloon placement.

Over the first 14 days after placement, patients may experience nausea or vomiting. Dr. Poulos recommends a liquid diet for his patients during the first week to help manage these symptoms.  Also prescribed are effective anti-nausea drugs to help the patient through the initial stage.

How is the balloon removed?

Once the stomach balloon has been in place for six months the balloon is removed. The simple and non-surgical procedure is very similar to the placement process. Once the gastric balloon has been removed, it is very important to continue working closely with Dr. Poulos’ team and coaches to follow the personal diet and exercise plan provided. This will help to keep you in a positive and healthy mindset while achieving your weight loss goals.

Additional benefits of the balloon weight loss method.

-It’s been shown that the average person loses 3x more weight with this procedure than with diet and exercise alone. Here are some of the reasons why:

-Diets can leave you feeling hungry or dissatisfied. This procedure helps by taking up room in the stomach and encouraging portion control.

-When you’re overweight, exercise can be challenging and uncomfortable. With The Balloon Weight Loss Method aiding your weight loss, physical activity can be more comfortable.

-There are no incisions, stitches, or scars.

-Unlike gastric bypass surgery, this procedure is not solely for the morbidly obese.

-The procedure takes 20 minutes and most patients return home the same day.

-The balloon is only placed temporarily.

-The procedure is intended to work with a fitness and nutrition regimen for optimal results.

Cost: The general cost for the procedure is $8,000 to $10,000 nationwide and can be used with patients 22 and older who fit all of the medical criteria.

About Dr. Stanley Poulos

Dr. Poulos specializes in cosmetic breast surgery and body contouring procedures. He helped pioneer the quick lift facial rejuvenation surgery in California and is recognized as one of the leading plastic surgeons in Marin County and the entire San Francisco Bay area.  Dr. Poulos and Plastic Surgery Specialists have extensive experience in body contour procedures. A graduate of the University of Texas Medical School, Dr. Poulos completed his internship and residency at UC San Francisco. He completed a plastic surgery fellowship at St. Francis Hospital in San Francisco and is certified by the American Board of Plastic Surgery. www.psspecialists.com

Heartland Institute Experts React to FDA

The advisory panel to the Food and Drug Administration voted 5-to-4 to reject a claim from Philip Morris International Inc. that “Switching completely to IQOS presents less risk of harm than continuing to smoke cigarettes.” Phillip Morris claims that using their IQOS device, which heats tobacco rather than burn it, could reduce the risk of tobacco related health issues compared to cigarettes.

“How many more smokers will have to die on the FDA’s watch until they catch up to the rest of the world when it comes to supporting harm reduction technologies?” Director of Government Relations John Nothdurft said. “The rest of  the world is far ahead of the United States in terms of supporting policies that help smokers quit or at a minimum move to less harmful alternatives such as heat-not-burn products, e-cigarettes, and snus.”