FDA Grants Market Clearance for Erchonia's Zerona Laser
Posted by on Sunday, 21st November 2010
FDA Grants Market Clearance for Erchonia’s Zerona Laser
Proven safe and effective for circumference reduction of the waist, hips and thighs
McKinney, TX August 30, 2010 – Erchonia Corporation, the world’s leading manufacturer in low-level
laser technology, has been granted market clearance by the U.S. Food and Drug Administration for the
non-invasive body contouring device, the Zerona. The Zerona is the first non-invasive aesthetic device to
receive FDA market clearance in the U.S. for circumferential reduction of the waist, hips, and thighs.
The FDA granted market clearance following the completion of a placebo-controlled, randomized, doubleblind,
multi-site clinical investigation evaluating sixty-seven study participants. The results obtained from
that study demonstrated an average inch loss reduction of 3.65 inches across patient’s waist, hips, and
thighs in as little as two weeks. The clinical trial, absent of diet restrictions, exercise requirements, or any
other adjunctive components properly illustrated the clinical utility of the Zerona and set the precedent on
how aesthetic devices should be evaluated.
FDA clearance for body contouring is just the latest clearance in a long line for Erchonia’s low-level laser
devices having already earned FDA market clearances for breast augmentation (2008), acne (2005),
liposuction (2004), and chronic pain (2001).
The Zerona emits a low-level, or cold, output energy that generates no thermal effect on the body’s tissue
eliminating any risk to the patient. Zerona has been clinically proven to target fat cells causing their
immediate collapse thereby significantly reducing body volume. Through a natural process of fat removal,
the laser-released fat is safely removed and broken down, providing patients with a truly non-invasive
procedure without side effects or downtime.
“Zerona is scientifically-proven to be both safe and effective, and this most recent FDA clearance simply
validates the research supporting this application,” says Charlie Shanks, vice president of Erchonia.
“Zerona’s FDA clearance makes it even more unique in the marketplace and we are excited to continue
the momentum with a new, integrated marketing campaign.”
Having no predicate devices to base FDA clearance on, the Zerona had to undergo a review process
called de novo, which is completed by the FDA in an average of 750 days. Erchonia submitted clinical
data in August 2008 and was granted approval for safety and effectiveness nearly two years later.
www.erchonia.asia
+91-22-65151222
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Rights for Zerona Non Invasive Laser Liposuction and Weight Loss Program Secured by AVI Pharma in Southeast Asia
Posted by on Sunday, 21st November 2010
Zerona Low level non invasive laser liposuction (http://erchonia.asia/index.htm) , used for body slimming also emerges as an innovative weight loss program (http://erchonia.asia/index.htm) and ideal way to balance appetite hormones. AVI Pharma recently gained the rights for the program in Southeast Asia, including India, Malaysia, Thailand, Indonesia, Pakistan and Sri Lanka. The procedure is US FDA approved.
(PRWEB) October 16, 2010
Zerona is a low-level non invasive laser liposuction for body slimming that also emerges as an innovative weight loss program. Together with or independent of very low calorie VLCD Diet, HCG injections or other weight loss programs. It rotates around the waist, hips and thighs, forcing the fat cells to empty in a matter of weeks. There are no incisions, no downtime and no need for anesthesia. The fat is reabsorbed by the body through natural detoxification channel via liver and lymphatic system. But there is no substitute of eating right and healthy life style. This liposuction laser mechanism has to work hand in hand with lifestyle modification.
Good news is that Food and Drug Administration just cleared Zerona for "body slimming" in doctors' offices to reveal a thinner body with no incisions or needles. The Zerona is the first non-invasive aesthetic device to receive FDA market clearance for circumferential reduction of the waist, hips, and thighs.
The obesity epidemic continues unabated with no cure in sight. This is adversely affecting social harmony and economic productivity in developing as well as developed countries. Since obesity is mainly dependent on the size of the fat cell not just the number of fat cells .It is important to see the good side of the adipocytes too. Usually thought to be a poisonous inflammatory reservoir of fat and toxins the good side of adipocytes is missed or misinformed not only to the population but also the medical fraternity. Destroying the fat cells can be dangerous.
For long we have been trying to reveal the real mystery around adipocytes. Now fat cells are not just considered as inactive storage form for excess calories. We can consider adipose tissue as one of the largest endocrine gland in the body responsible for release of multiple hormones and sending signals to target tissues all over the body to regulate fatty acid metabolism, growth, puberty, healing, temperature control, disease-fighting ,aging and hunger mechanism. More than 20 hormones, both orexigenic and anorexigenic, have been identified. After crossing the blood-brain barrier, they reach their main site of action located in several hypothalamic areas and interact to balance satiety and hunger. One of the most significant advances in this matter has been the discovery of Leptin. This hormone plays fundamental roles in the control of appetite and in regulating energy expenditure.
The metabolism of adipocytes and gastric epithelial cells is closely linked to food intake and energy storage. The coordinated secretion of adipose and gastric leptins ensures proper management of food processing and energy storage. Leptin also regulates the activities of enzymes involved in lipid metabolism, e.g., AMP-activated protein kinase and stearoyl-CoA desaturase-1, and also interacts with insulin signaling in the brain. Low levels of leptin indicating food deprivation and depleted fat stores have been identified as the strongest signals to induce adaptive biological actions such as increased energy intake and reduced energy expenditure. The fall in leptin during fasting mediates hyperphagia and suppresses thermogenesis, thyroid and reproductive hormones, and immune system. On the other hand, rising leptin levels in the fed state stimulate fatty acid oxidation, decrease appetite, and limit weight gain. Because of this LEPTIN, is often known as the fat switch.
Similar changes can be observed when the adipocytes are damaged or destroyed by various invasive and non invasive slimming techniques. Most protocols for slimming and aesthetics involves destruction or removal of the adipocytes. This destruction of fat cells without diet control or exercise can stimulate the adipocytes elsewhere in body to get bigger and store more fat and ultimately non aesthetic results. Another danger is that losing fat cells may lower leptin levels and increase leptin resistance, signaling to the brain to eat more. In concert with other signals from the gut and metabolically active tissues, low leptin levels trigger powerful activation of multiple peripheral and brain systems to restore energy balance. It is not just neurons in the arcuate nucleus, but many other brain systems involved in finding potential food sources, smelling and tasting food, and learning to maximize rewarding effects of foods, that are affected by low leptin. Food restriction and fat depletion thus lead to a "hungry" brain, preoccupied with food.
Among multiple hormones that fat cells secrete another example is ADIPONECTIN, which helps manage metabolism. It enhances fatty acid oxidation and insulin sensitivity, in part by stimulating AMP-activated protein kinase phosphorylation and activity in liver and muscle. Moreover, Adiponectin decreases body fat by increasing energy expenditure and lipid catabolism. It is also known that Adiponectin release decreases when the fat cells are oversize. On the other hand oversize fat cells also become resistant to Leptin itself explaining why very obese individuals may have high leptin but are resistant to it,very similar to insulin resistance.
Ideally the best slimming & weight loss program to get maximum advantage from the endocrine fat cells is to shrink the fat cells without damaging them. This not only will increase leptin sensitivity but will also increase production of Adiponectin. This goal can be achieved by a non invasive protocol using low level laser liposuction which deflates/shrinks the fat cells without damaging the adipocytes and maintaining the endocrine function.
www.erchonia.in
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See your impact on the life of others.Change dreams into reality
Posted by on Sunday, 21st November 2010
Dear Physician Friends, As the Founder of www.WorldAntiagingNetwork.com,and Age Management and Research AMAR-India , I would like to inform you that we are starting programs supporting healthcare at grass root level. We are looking forward to help physicians who are involved in charity and have and impact on changing the lives of those who need help. Feel free to visit www.antiagingindia.com and add your story as a blog on WAAN. Lets join hands and make India a Healthy Nation. Regards Dr Anoop Chaturvedi feel free to contact me
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Age Management Medicine and Research, an Official Sponsor of the Microsoft Alumni Foundation, Supports SeeYourImpact.org
Posted by on Sunday, 21st November 2010
– Thu Nov 18, 12:30 am ET
AMAR India is proud to be an Integral Sponsor of the Microsoft Alumni Foundation 2010 Celebration, supporting non-profit organization SeeYourImpact.org’s innovative approach to charity, by showing donors the direct impact of their donations on people’s lives.
Seattle, WA (PRWEB) November 17, 2010
Age Management Medicine and Research (AMAR India) is proud to be an Integral Sponsor of the Microsoft Alumni Foundation 2010 Celebration, supporting non-profit organization SeeYourImpact.org’s (http://SeeYourImpact.org) innovative approach to charity, by showing donors the direct impact of their donations on people’s lives.
On November 18th in Seattle, the Microsoft Alumni Foundation will host its second annual celebration honoring the Microsoft community’s accomplishments in philanthropy. Bill and Melinda Gates will recognize award winners and nominees of the Integral Fellows for their commitment to changing lives through philanthropic service. The winners of the Integral Fellows Award will each receive a $25,000 unrestricted grant for their nonprofit organization, as well as support from their fellow alumni to help continue in their efforts to leverage resources and scale solutions for their initiatives.
The panel of judges includes: Tom Brokaw, journalist and author, Bill Drayton, chair and CEO, Ashoka, William H. Gates Sr., co-Chair, Bill & Melinda Gates Foundation, Pierre Omidyar, Founding partner, Omidyar Network and Founder and Chairman, eBay Inc., Judith Rodin, President, Rockefeller Foundation, Thomas J. Tierney, Chairman and Co-founder, Bridgespan Group.
AMAR India is proud to support the work of the Integral Awards Program, including its chosen charity, SeeYourImpact.org. “We are honored to provide support for the philanthropic accomplishments of the Microsoft Community,” said Dr. Anoop Chaturvedi, Founder, AMAR India.
“We are very happy to announce that Mark Shanks, COO of Erchonia Corporation USA, world leader in low level laser technology, has agreed to donate its latest wound-healing lasers with the support of Scott Oki and Digvijay Chauhan, Co-founders, of SeeYourImpact.org to medical institutes in India. These lasers will greatly aid burn victims, diabetic patients with non-healing wounds, and patients struggling with mobility who are suffering with bed sores in hospitals and retirement homes. This will change the way we look at the healing process from healing wounds to healing life.” said Rowland Hanson, Chairman Erchonia India.
The Microsoft Alumni Foundation brings together Microsoft alumni to positively affect the world's challenges. "We've been fortunate to play a significant part in the information revolution. Now we have a chance to change the world in a different way. Microsoft alumni are making it happen every day in our local communities and around the world," said Jeff Raikes, chairman of the board of the Microsoft Alumni Foundation. "Some very unique individuals were nominated by their peers as Integral Fellows for their work deeply rooted in service and making a difference in people's everyday lives.”
About SeeYourImpact.org: SeeYourImpact.org (http://SeeYourImpact.org) is a revolutionary way to help those in need around the world and next door. Give a small gift. In about two weeks, you’ll receive a photo and story of the person you helped. By showing donors who and how their gift changed someone’s life, SeeYourImpact.org transforms charitable giving into a fun, transparent experience. SeeYourImpact.org offers over 70 charitable innovations in more than 15 countries spanning 3 continents.
About the Foundation: The Microsoft Alumni Foundation was established to catalyze the collective power of the Microsoft alumni family and leverage our resources on innovative, scalable and transformative solutions to our world's challenges. Launched in 2007, the Foundation is a 501(c)(3) public nonprofit organization with its worldwide headquarters based in Bellevue, Washington, USA. Board members include: Jeff Raikes (chair); Chuck Hirsch (president); Scott Oki (co-founder and vice president); Paul Shoemaker (treasurer); Tony Audino (co-founder); Sharon Maghie (co-founder and secretary) and Brad Smith (Microsoft representative).
About AMAR India: The mission of Age Management Medicine and Research India is to introduce the concept of graceful and healthy aging. It helps establish complete businesses for those who have the same goals. It brings the latest science and technology for improvement of the quality of life of patients through age management and anti-aging conferences and courses for physicians. It promotes a unique social platform where like minded physicians dealing with aging and age-related diseases can come together to connect, learn and collaborate with each other. AMAR India together with Erchonia USA and SeeYourImpact.org is dedicated to changing lives at the grassroots-level from suffering to healing. AMAR India is a private company, based in Mumbai India. Learn more at http://www.antiagingindia.net.
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TEXTING WHILE DRIVING will claim more Lives than any deadly disease!
Posted by on Thursday, 10th June 2010
NEJM Perspective: 'It's Time for Us to Ask Patients About Driving and Distraction'
A perspective in the New England Journal of Medicine stresses the necessity of counseling patients about the dangers of texting and talking on cell phones while driving. The author concludes that by not educating patients about the risks, physicians "place in harm's way those we hope to heal."
The author shares her strategy: After asking patients about their habits, she tells them that "driving while distracted is roughly equivalent to driving drunk." She then asks whether they could limit their cell phone use in the car, and offers alternatives, including pulling over to make calls.
She says that "although no direct correlation can be made, we know that counseling patients about dangerous behaviors can have powerful consequences." As evidence, she points to the U.S. Preventive Services Task Force, which says that talking to a patient for just 3 minutes about the dangers of smoking increases the odds that the patient will quit.
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