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Medical Grade Vacuum Device

Red stamp with text FDA Approved

 

Medical grade vacuum erection devices for erectile dysfunction also known as penis pumps are regulated by the Food and Drug Administration (FDA).  They are classified as a Class II Medical Device. Buyers beware! There are currently hundreds upon hundreds of different ED pumps for sale. Price’s and design very quite a bit among the many available options. Despite numerous ED pump choices, there are currently only seven manufacturers who are registered as medical grade device manufacturers with the FDA. This fact might prove valuable when deciding which product to purchase. Click on the following link, Medical Grade Vacuum Erection Device to determine which manufacturers produce medical grade products. If the creator of the product you are considering to purchase is not registered on this website, the product is being marketed illegally to the public.

 

Does it matter if the ED pump you purchase is Medical Grade and legally marketed?

 

  1. An FDA registered manufacturer of a vacuum erection device must follow (GMP) Good Manufacturing Practices.
  2. As a manufacturer following Good Manufacturing Practices, Quality Assurance Programs and Quality Testing determine how these ED Pumps are produced and ensure high quality standards and safety for the men and women who use these products.
  3. The FDA routinely inspects these manufacturers to ensure compliance to the regulations, and to guarantee that adequate labeling and high safety standards are met.

 

Why are so may ED Pumps marketed illegally?

 

The FDA is responsible for oversight and regulation of medical devices and drugs.  Many Class II medical devices do not require Premarket Notification and fall under an existing 510(k) for a product. Manufacturers of vacuum erection devices, or their devices, can not be FDA approved but are deemed substantially equivalent to the original 510(k) issued in 1982. However, each manufacturer must by law register with the FDA and comply with their guidelines.  Class II medical devices are not considered as dangerous to the public as many implantable devices or prescription drugs.  The FDA’s first priority are products that potentially have deadly side effects or present major health threats. This does not mean that ED Pumps do not have safety issues, because they can and do. Class II devices are generally thought to be less risky.  However, if you are considering an illegally marketed vacuum erection device it does not mean these products are safe or that the FDA will not shut down the manufacturer. It may mean the FDA has not yet audited the manufacturer. The MegaVac System is an example of an illegally marketed and manufactured product in which the FDA took action.

Medical Grade Vacuum Device

 

Medical Grade Vacuum Device

 

Augusta Medical Systems is a United States manufacturer of medical grade vacuum erection devices.  Soma Therapy ED has a success rate over 90%.  All of our devices are designed, manufactured, and shipped directly from Augusta Georgia.  Please take an opportunity to learn about Soma Therapy-ED and view all of our medical grade vacuum therapy devices.  If you have questions and would like to speak with a customer support specialist you can call 1-800-827-8382.

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Medicare and the Vacuum Erection Device

During the 2014 winter session of congress legislatures enacted a bill titled the ABLE Act. The bill passed the United States Senate as a bipartisan law to create tax free savings accounts for individuals with disabilities.  To offset the legislation’s cost Medicare eliminated, among other spending cuts, reimbursement for vacuum erection devices as a covered treatment for erectile dysfunction.

While Medicare will officially discontinue coverage for the VED on July 1, 2015, and as a double-negative for Medicare beneficiaries who “would” have qualified for reimbursement, coverage was practically eliminated for most Medicare beneficiaries in August of 2014.  Many men who would have qualified for coverage in July of 2014 were unlikely to qualify for Medicare coverage by September of 2014.

Medicare and Medicaid Services (CMS) adopted a new Local Coverage Determination (LCD) policy in August of 2014 that effectively reduced the number of men who seek and qualify for Medicare coverage by potentially as much as 60%.

The August 2014 Local Coverage Determination (LCD) created requirements that mandate extensive medical documentation of prior treatment courses for ED, ask doctors to rule out hypogonadism as a cause of ED, require a genital examination and digital rectal exam, and impose upon physicians to create detailed written notes.  This requirement goes beyond simple medical necessity statements and the more traditional use of diagnosis coding.  The August 2014 LCD for vacuum erection device coverage created a new standard for treatment described by many physicians as extreme.

For those select male Medicare beneficiaries who meet the very specific requirements of the August 2014 LCD, Medicare coverage for a vacuum erection device is available but the clock is ticking………. .

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Nocturnal Erections and Penile Health

Nocturnal Erections and Penile Health

Night time

 

Nocturnal erections

 

Nocturnal penile tumescence (NPT) is a spontaneous erection of the penis during sleep or when waking up. Several less formal and well-known expressions might be morning hard on, morning wood or descriptions like morning glory all used to describe this natural anatomical process.  Have you ever wondered what causes the phenomenon?

 

What causes nocturnal erections?

 

man getting into bedSeveral theories are popular, none entirely proven. One is that spontaneous night time erections may be caused by a full bladder, which is known to cause mild stimulation of a region of the spinal cord containing nerves that control a man’s ability to have so called “reflex” erections.

Some clinical studies suggest testosterone is thought to be at its highest levels in the morning at that this may provide an explanation.  The connection between testosterone levels and nocturnal erections is not very conclusive.

There is evidence that spontaneous erections begin early in the life of males.  Fetal penile erections have been recorded in ultrasound scans so it is difficult to imagine that these types of erections are related in any way to acts of sex, so what physiological role do they play?

 

Sleep Cycle

REM sleep is associated with spontaneous erections

 

Most men have 3-5 spontaneous erections during deep sleep.  REM sleep is one of five distinct phases of sleep.  Because sleep cycles repeat, everyone enters REM sleep several times a night.  This is when dreaming is most common.

REM-related erections have been observed in all mammalian species where they were looked for. No-one knows why REM-related erections occur.  So why do men wake up with an erection?

 

Man waking up in the morning

 

 

Why do men wake up with an erection?

 

Scientific explanations as to why men get erections in the morning may vary, and the absolute cause may not be exactly known.   However, the way scientist and medical doctors use the presence of nocturnal erections as a diagnostic tool is very clear.

A study in the Urologic Clinics of North America noted that Nocturnal Penile Tumescence (NPT) monitoring remains the best single non-invasive examination to distinguish between whether erectile dysfunction or impotence has a physical cause or psychological cause.

 

Nocturnal penile tumescence test

 

Nocturnal penile tumescence tests are used to determine if the cause of impotence is physical, psychological, or both.  By determining if men achieve 3-5 erections during rem sleep a physician maybe able to begin the process of understanding how to treat the underlying conditions that have created ED.

 

The stamp test is one of the most common and simple ways to test for nocturnal penile tumescence. Types of erectile dysfunction tests can vary depending on your symptoms and the recommendation of your doctor.

 

The chances are if you do not experience nocturnal erections spontaneously during sleep that there is a physical cause to the impotence or ED you are experiencing.  If this is not diagnosed by your physician it’s time to work with your doctor to determine the cause.

 

Penile Health and exercise

 

Penis Health

 

Routine erections in a 24-hour time period are necessary to keep your penis in shape. Penile rigidity and erections bring oxygen to the penis. Use it or lose it is a common term and applies to penile health.

The penis in its flaccid or non-erect state it does not have adequate blood flow and oxygenation to keep penile tissues healthy. Without blood flow every 24 hours in the form of spontaneous nighttime erections penile atrophy, programmed cell death, and penile shrinkage may occur due to the lack of erections.

In a clinical study published in the Journal of Sexual medicine theories that support penile rehabilitation using a vacuum erection device are presented.

 

Penile rehabilitation

 

Time to heal stopwatch

Many physicians who treat prostate cancer focus on minimizing the side effects of erectile dysfunction resulting from treating cancer.  Erectile function, including nocturnal erections, may be lost if nerves are severed during removal of the prostate.

Penile rehabilitation is the process of preventing penile atrophy, programmed cell death and penile shrinkage by using a medical intervention to create erections that “exercise” the penis.

The goal of penile rehabilitation is to maintain and create penile health through artificially induced erections so a man may return to natural erectile function when severed nerves heal.  The effectiveness of penile rehabilitation for maintaining and creating penile health is widely debated.

Vacuum erection devices are considered first-line therapies of erectile dysfunction and preservation (rehabilitation) of erectile function following treatment for prostate cancer. 

An erectile dysfunction pump is considered the treatment of choice for penile health and rehabilitation because multiple erections (5-8) can be created and released in one therapeutic session (during a 10 minute session). 

This process is thought to mimic the creation of multiple nocturnal erections that would normally occur during REM sleep in a 24-hour period without the use of drugs or needles.  Thus, it is a natural way to bring blood flow and oxygenation to penile tissues to prevent penile shrinkage, atrophy, and programmed cell death.

Much research and debate will be needed in the future. Will the practice of penile rehabilitation translate to all men who do not achieve nocturnal erections?

Will similar penile rehabilitation treatment protocols be used for men who are diabetic, suffer from metabolic syndrome, or take medications that eliminate nocturnal penile tumescence? 

 

Best Penis Pump

 

Soma Therapy ED Penis Pump

 

 

You can purchase a medical grade penis pump, formally available by prescription, without a prescription from Augusta Medical Systems!

 

Learn about Soma Therapy ED

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Penile Rigidity and Penile Health

Erectile dysfunction is defined as the inability to achieve and maintain an erection that is sufficient for sexual intercourse. For many of the right reasons we focus on erectile dysfunction, or absence of penile rigidity, in terms of how it impacts sexual intimacy and the relationships of couples effected by ED.

You might find it interesting to know there is more to erectile function or penile rigidity than its impact on sexual relationships, emotional well being, and self-esteem.  Beyond psychology, healthy erectile function and penile rigidity may also be important on a physiological basis and maybe on a cellular level.

Consider the following …..

Whether you have normal erectile function or not, most of the time the penis is in a non-erect or flaccid state.

When the penis is flaccid or in a non-erect state it does not receive and hold the same amount of blood as a penis that is rigid or erect.  Like all other organs in the body, an adequate amount of oxygen and blood flow is necessary to keep tissues and blood vessels healthy.

When the penis is erect it is believed that as much as six times the blood flow enters the organ compared to when it is non-erect or flaccid.  The presence of oxygen rich blood flow stretches, expands, and enriches the penile tissues.

Erections, thought by many as simply necessary for sexual intercourse, are also believed by many doctors and medical researchers to prevent tissue atrophy, programmed cell death, and penile shrinkage.  This belief is so because blood flow and erections or penile rigidity occur together.

Because erections are a blood filling process that brings oxygen and nutrient rich blood flow into the organ, the absence of erections may be detrimental to penile tissues.

So the relationship between achieving penile rigidity or erections and penile health on a tissue and cellular level may be intricately related.  Without penile rigidity or erections, the health of penile tissues may be put at risk.