Connect with us

Technology

Spatz Medical Marks Milestone: Spatz3 Adjustable Gastric Balloon Launches in the U.S. in March 2024

Published

on

FORT LAUDERDALE, Fla., Feb. 29, 2024 /PRNewswire/ — Spatz Medical, a global leader in gastrointestinal weight loss solutions, is delighted to announce the commencement of commercialization of the Spatz3 Adjustable Gastric Balloon. With over 150,000 patients benefiting from the Spatz3 across more than sixty markets globally, the company is now poised to launch this revolutionary technology in the United States.

 

Spatz3 – Transforming Weight Loss with Adjustability

The Spatz3 Adjustable Gastric Balloon, renowned as the first and only adjustable gastric balloon, has earned widespread acclaim for its outstanding weight loss results and an impressive 84% success rate, as demonstrated in the FDA Pivotal trials and real-world applications. Developed by Dr. Jeffrey Brooks, CEO of Spatz Medical, the Spatz3 introduces a unique adjustability feature, allowing physicians to customize the balloon volume during the treatment period, addressing key challenges faced by traditional gastric balloon systems.

Clinical Trial Results from Pivotal Study:

The Spatz3’s efficacy and safety profile, as reported in the FDA Pivotal Study and published in The Lancet, established a new threshold for Intragastric Balloon results. Noteworthy outcomes include:

Fivefold Greater Weight Loss: Spatz3 Balloon patients achieved a remarkable 15% reduction in initial weight, in contrast to the control group’s 3% weight loss.Successful Weight Maintenance: 74.3% of patients maintained clinically significant weight loss for six months after balloon removal.Customized Adjustments: The adjustability feature played a crucial role, with down adjustments alleviating intolerance in 82% of cases and up adjustments at 18 weeks resulting in an additional 15.2% excess weight loss.Extended Treatment Time: the Spatz3 is approved for an 8-month treatment period, leading to more successful patient outcomes when compared to a standard, non-adjustable 6-month balloon.

Dr. Jeffrey Brooks on the Milestone Achievement

Dr. Jeffrey Brooks expressed his enthusiasm for this milestone, stating, “The completion of the FDA Post Approval Study enrollment and the affirmation of our clinical trial results mark a pivotal moment for Spatz Medical. For the first time in gastric balloon history, an adjustable gastric balloon affords patients a decision making role in their weight loss therapy, customized to their needs. That is reflected in the outstanding 15% weight loss and 84% success rate, not previously achieved by gastric balloons in FDA trials. With a substantial global presence and over 150,000 patients benefiting from Spatz3, we are thrilled to bring this proven solution to individuals across the United States.”

Comments from Professor Barham Abu Dayyeh MD, Internationally Renowned Innovator and Investigator of Bariatric Endoscopic procedures in the US.

Professor Abu Dayyeh, Principal Investigator of the Spatz3 FDA Pivotal Trial and Post Approval Study stated,

“The Spatz3 brings a new dimension in endoscopic bariatrics with its proprietary adjustability technology. The ability to change balloon volume during the course of treatment yielded an impressive 15% total body weight loss and 84% response rate in FDA clinical trials. Spatz will be an important and welcome addition to the endoscopic bariatric options in the US.”

Continued Commitment to Innovation

Spatz Medical remains committed to advancing the field of bariatric endoscopy through continued innovation. The Spatz3’s adjustability feature is a paradigm shift for intragastric balloons. It offers new possibilities for patients, including alleviating symptoms of balloon intolerance, preventing early intolerance with gradual filling of the balloon, and a rejuvenation option for those experiencing weight loss plateaus.

The Spatz3 is approved for use in adults with obesity and provides a customizable approach to weight loss for individuals who have not achieved desired results through supervised weight control programs, or who have failed with standard non-adjustable balloons.

For more information about Spatz Medical and the Spatz3 Adjustable Gastric Balloon, please visit www.SpatzMedical.com.

Media contact:
Mickey Nave
mickey@spatzmedical.com

Logo – https://mma.prnewswire.com/media/1730863/3302275/Spatz_Logo.jpg

View original content:https://www.prnewswire.com/news-releases/spatz-medical-marks-milestone-spatz3-adjustable-gastric-balloon-launches-in-the-us-in-march-2024-302075949.html

SOURCE Spatz Medical

Continue Reading
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

Technology

Dana-Farber Cancer Institute Partners with Clinical.ly to Enhance Regulatory Operations with eReg Solutions

Published

on

By

NEW YORK, Sept. 19, 2024 /PRNewswire/ — The Dana-Farber Cancer Institute, a world leader in cancer treatment and research, chose Clinical.ly’s (www.clinical.ly) Research Suite™ to streamline regulatory operations, marking a significant step toward more efficient and compliant clinical trial management. Dana-Farber joins a growing number of research organizations that leverage Clinical.ly’s innovative solutions to streamline clinical trial processes. Clinical.ly’s eReg platform offers a comprehensive, paperless solution that centralizes regulatory workflows, ensuring compliance and transparency across clinical trials.

“We are thrilled to support Dana-Farber’s clinical research operations,” said Henry Kravchenko, Clinical.ly’s CEO.

This partnership continues Clinical.ly’s success in providing best-in-class enterprise tools for conducting clinical research. “We are thrilled to support Dana-Farber’s clinical research operations,” said Henry Kravchenko, Clinical.ly’s CEO. “Our eReg platform and wider set of features in Clinical.ly Research Suite™ will empower that renowned organization, and we all look forward to supporting their teams.”

About Clinical.ly Research Suite™ 

Clinical.ly Research Suite™ is a comprehensive solution that eliminates traditional, paper-based processes. By automating and centralizing essential workflows in the Clinical.ly Research Suite™, organizations achieve huge efficiency improvements, greater trial oversight, document management, and regulatory compliance. The Clinical.ly Research Suite™ includes:

eReg: A best-in-class electronic regulatory bindereSource: An intuitive & feature-rich, paperless data capture solution that streamlines data collection from trial participantseConsent: A fully digital solution for capturing informed consent, improving participant engagement and site complianceClinicallySign: 21 CFR Part 11 compliant eSignature functionalityClinicallyPay: A secure and instantaneous participant stipend payment and reimbursement solution

About Dana-Farber Cancer Institute

Founded in 1947, Dana-Farber Cancer Institute is committed to providing adults and children with the best treatment available today while developing tomorrow’s cures through cutting-edge research. Based in Boston, Dana-Farber is a teaching affiliate of Harvard Medical School and ranks consistently as one of the top cancer hospitals in the world.

About Clinical.ly

Clinical.ly provides differentiated, cloud-native technology solutions to the clinical research industry, enabling research organizations to conduct studies with greater efficiency and ease. Clinical.ly is dedicated to developing technology that eliminates tedious manual labor, allowing clinical research professionals to focus on patient care.

View original content to download multimedia:https://www.prnewswire.com/news-releases/dana-farber-cancer-institute-partners-with-clinically-to-enhance-regulatory-operations-with-ereg-solutions-302253690.html

SOURCE Clinical.ly

Continue Reading

Technology

Fall Into Creativity with the Monport Laser Fall Sale

Published

on

By

NEW YORK, Sept. 19, 2024 /PRNewswire/ — Experience laser innovation this Fall with Monport Laser, an industry frontrunner in laser engraving and cutting technology, with an exclusive Fall Sale offering incredible discounts and free accessories on a wide range of high-performance laser engraving machines. From September 19th to September 30th, customers can take advantage of this limited-time opportunity to elevate their laser engraving businesses with cutting-edge laser innovation at unbeatable prices.

Monport Laser has been dedicated to providing innovative and reliable laser machines that empower businesses and individuals to achieve their goals. With a focus on quality, precision, and customer satisfaction, Monport Laser has established itself as a trusted leader in the industry. Their commitment to excellence is evident in every laser they produce, ensuring exceptional performance, reliability, and value.

Embrace the Power of CO2 Laser Technology with Exclusive Offers

Monport Laser will offer two free accessories with selected CO2 laser machines during the Monport Fall sale. These versatile lasers are ideal for various applications, including engraving, cutting, and marking wood, acrylic, leather, and more. By taking advantage of this Fall sale, laser engraving businesses can enhance their productivity and expand their creative possibilities.

Experience Unmatched Value with Fiber Laser Discounts

Monport Laser offers substantial discounts of up to $4200 and 3 free accessories on selected models for those seeking the precision and speed of fiber laser technology. Fiber lasers are renowned for their ability to process metals with exceptional efficiency and accuracy, making them indispensable for metal fabrication, manufacturing, and jewelry production. Additionally, customers purchasing fiber lasers during the Fall sale will receive three free accessories, further sweetening the deal.

Elevate Your Desktop Laser Experience with a Free Water Chiller

Monport Laser is committed to providing comprehensive solutions for businesses of all sizes. As part of the Fall sale, customers who purchase the 40W Desktop laser will receive a Free Water Chiller Cw3000. This essential accessory ensures optimal cooling and performance, prolonging the lifespan of the laser and guaranteeing consistent results.

Discover Additional Savings on a Wide Range of Accessories

Monport Laser offers an additional 20% discount on selected accessories to complete your laser setup. From lenses and nozzles to rotary tables and smoke extraction systems, customers can find everything they need to maximize the potential of their laser machines.

Unleash Your Creativity and Productivity

Monport Laser’s Fall sale is the perfect opportunity to invest in laser technology that empowers your business or fuels your creative passions. With exceptional discounts and free accessories, you can acquire the ideal laser solution to meet your needs and budget.

Whether you’re an entrepreneur, artist, or manufacturer, Monport Laser’s advanced laser machines offer unparalleled precision, versatility, and reliability. Take advantage of this limited-time Fall sale and unlock your projects’ full potential for laser innovation.

About Monport Laser

Monport Laser is a global leader in designing, manufacturing, and distributing high-quality laser machines and accessories. With a commitment to innovation and customer satisfaction, Monport Laser provides cutting-edge solutions for various industries, including manufacturing, engraving, marking, and more.

For more information, visit monportlaser.com and follow them on social media for the latest updates.

Website: https://www.monportlaser.com/

 

 

 

View original content:https://www.prnewswire.com/news-releases/fall-into-creativity-with-the-monport-laser-fall-sale-302253699.html

SOURCE Monport Laser

Continue Reading

Technology

MEDIA ADVISORY – Minister Wilkinson to Make a Critical Minerals Infrastructure Announcement

Published

on

By

VANCOUVER, BC, Sept. 19, 2024 /CNW/ – The Honourable Jonathan Wilkinson, Minister of Energy and Natural Resources, and Ranj Pillai, the Premier of Yukon, will make a funding announcement in support of critical minerals infrastructure projects. A media availability will follow.

Date: September 20, 2024

Time: 10:30 a.m. PT

All accredited media are asked to pre-register by emailing media@nrcan-rncan.gc.ca. A dial-in line is available for media and will be provided upon registration.

Follow us on LinkedIn

SOURCE Natural Resources Canada

Continue Reading

Trending