Navigation Links
The Spatz Adjustable Balloon System® for Weight Loss Becomes the First Intragastric Balloon to Receive Regulatory Approval for 1 Year Implantation Time
Date:11/16/2010

JERICHO, N.Y., Nov. 16, 2010 /PRNewswire/ -- Following results of its 12 month study in Europe, Spatz FGIA, Inc. has received regulatory approval for extension of the implantation period from six months to 12 months. Intragastric balloons for weight loss have been used successfully for the last 17 years outside of the US, however, the risk of balloon deflation with subsequent bowel obstruction has mandated removal of all intragastric balloons at six months. The unique anchoring system of the Spatz device protects a deflated balloon from advancing into the intestines, allowing it to be used safely beyond six months.

"While we welcome this extraordinary news, extending the implantation time alone is not enough to produce greater weight loss. Non-adjustable balloons lose their effect within 2 to 4 months, so additional implantation time is not likely to increase weight loss significantly," said Dr. Jeffrey Brooks, founder and CEO of Spatz.   "Only an adjustable balloon can offer repeated waves of weight loss, after the balloon volume is adjusted upward," he continued.

The European study has reported an additional 8 kg (17.6 lbs) weight loss following adjustments. In addition, intolerant patients have been successfully adjusted downward, with continued weight loss. Adjustments plus extended implantations have resulted in an average weight loss of 35.5 kg (78 lbs) at the end of one year – achieving loss of 67% of their excess weight. "The potent combination of adjustability and one year implantation is unique to the Spatz device, and will open up a new era in endoscopic weight management," continued Brooks.

"Our gastric balloon specialists have requested adjustability and longer implantation time- and we can now deliver this unique combination," said David Hofstadter, Director of Marketing and Business Development. "We have been overwhelmed with requests from every corner of the planet," he continued, "and we intend to make this a worldwide product."

In the future, Spatz intends to pursue two and three year implantation times, potentially becoming a chronic endoscopic weight management tool.  "All devices have been examined in our lab after removal at 12 months, and have remained completely functional," said Eran Hirszowicz, chief engineer. "From an engineering and functional point of view, we see no reason to limit implantation to one year," he continued.

About Spatz FGIA, Inc.

Spatz FGIA, Inc. is a medical device company that has created the next generation gastric balloon for the worldwide obesity epidemic. Now available for commercial use in Europe as well as many countries around the world, the company's flagship product, the Spatz Adjustable Balloon System®, offers a unique non surgical solution for the overweight and obese. The 15 minute out-patient procedure reduces stomach capacity to give patients a feeling of satiety. Patients are discharged home within one hour after insertion. It is not approved by the FDA for use in the United States.

For further information, visit www.spatzmedical.com.


'/>"/>
SOURCE Spatz FGIA, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. IRIDEX Announces Commercial Availability of New Adjustable & Intuitive EndoProbe® Device for Eye Surgery
2. IRIDEX Granted U.S. Patent for Adjustable Laser Probe for Eye Surgery
3. Drug-Coated Balloons Slowly Making Their Mark on the European Interventional Cardiology Market
4. OrbusNeichs Genous™ Bio-engineered R stent™ Shows Favorable Safety Profile and Clinical Outcomes in Combination with Paclitaxel-Coated Balloon for De Novo Coronary Artery Disease
5. Angioslide Commercializes in the U.S. First Device to Combine Balloon Angioplasty and Embolic Capture
6. Endologix Enters Development Agreement and Exclusive License for Balloon Expandable Stent Technology
7. Data Show OrbusNeichs Genous™ Bio-engineered R stent™ is Safe and Effective in Combination with Drug-Eluting Balloon
8. First Coronary Stent on Drug Eluting Balloon Implanted
9. Spiral Enteroscopy is Three Times Faster than Double-Balloon Enteroscopy in Diagnosing the Small Intestine, New Study Finds
10. Osseon Therapeutics Demonstrates to the European Medical Community How to Think Outside The Balloon When Treating Vertebral Compression Fractures
11. Volcano Announces Distribution Agreement With AngioScore for the AngioSculpt(R) PTCA Scoring Balloon Catheter in Japan
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... ANGELES , June 23, 2016 ... CAPR ), a biotechnology company focused ... therapeutics, today announced that patient enrollment in its ... in Duchenne) has exceeded 50% of its 24-patient ... enrollment in the third quarter of 2016, and ...
(Date:6/23/2016)... BOGOTA, Colombia , June 23, 2016  Astellas today announced the establishment of Astellas Farma Colombia (AFC), a ... second affiliate in Latin America . ... ... ... ...
(Date:6/23/2016)... , June 23, 2016  Experian Health, ... and transforming the patient payment and care ... innovative new products and services that will ... revenue cycle offerings. These award-winning solutions will ... workflows, remain compliant in an ever-changing environment ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency ... named Dr. Sesan Ogunleye, as the Medical Director of its new Mesquite-Samuell Farm facility. ... Director of our new Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director ...
(Date:6/25/2016)... ... 2016 , ... Conventional wisdom preaches the benefits of moderation, whether it’s a ... the bar too high can result in disappointment, perhaps even self-loathing. However, those who ... , Research from PsychTests.com reveals that behind the tendency to set ...
(Date:6/24/2016)... ... ... a crisis. Her son James, eight, was out of control. Prone to extreme mood shifts ... upset him, he couldn’t control his emotions,” remembers Marcy. “If there was a knife ... and say he was going to kill them. If we were driving on the ...
(Date:6/24/2016)... CA (PRWEB) , ... June 24, 2016 , ... Comfort ... the American Cancer Society and the Road To Recovery® program to drive cancer patients ... seniors and other adults to ensure the highest quality of life and ongoing independence. ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... proud to recognize Dr. Barry M. Weintraub as a prominent plastic surgeon and ... women in the world, and the most handsome men, look naturally attractive. Plastic ...
Breaking Medicine News(10 mins):