Study demonstrates high success rates, ease of use, and economic value in the treatment of GI defects
AUSTIN, TX / ACCESSWIRE / November 1, 2021 / Apollo Endosurgery, Inc. ("Apollo") (NASDAQ:APEN), a global leader in minimally invasive medical devices for gastrointestinal and bariatric procedures, announced the publication of a multi-center study of the X-Tack®System in closing challenging gastrointestinal defects.
Removal of gastrointestinal lesions is one of the most common procedures in endoscopy and may result in defects which can lead to perforation or bleeding if not closed properly. Prevailing devices such as through-the-scope (TTS) clips or over-the-scope (OTS) clips often cannot effectively close large, wide, irregular, and difficult to reach defects. This study aimed to assess the feasibility and safety performance of the X-Tack System to address these limitations.
The multicenter study included ninety-three subjects who were treated at eight centers in the United States, including the Mayo Clinic, Johns Hopkins Hospital, Brigham and Women's Hospital, and New York University, among others. The study focused on large, challenging defects in both the upper and lower GI tract, specifically those that would be difficult or impossible to close with alternative devices. The primary outcomes were feasibility (defined by technical success of the procedure) and safety.
- Mean defect size was 37mm ± 20mm
- Technical success was achieved in 89.2% of patients.
- 68% of defects were closed with a single X-Tack device. 18% of defects were closed with two and 12% were closed with three or four X-Tack devices.
- In 25% of cases X-Tack was used in combination with another closure device. All of these cases were done at just one of the eight centers.
- The investigators indicated that 24.7% of patients had defects that could not have been successfully closed using through-the-scope clips or over-the-scope clips.
- No serious adverse events occurred
Dr. Andrew Storm, co-director of the Mayo Clinic Developmental Endoscopy Unit and an investigator in the study commented, "The outcomes of this study support our ongoing, daily use of X-Tack. It allows us to close challenging resection sites, and it may cut down on costs associated with performing these highest quality, safest possible, polyp removal procedures."
"We believe X-Tack has the potential to be play a significant role in improving GI defect closure. The findings from this multicenter study demonstrate X-Tack's capability to reach and close GI defects, underscoring the device's strong clinical and economic value," said Chas McKhann, President and CEO of Apollo Endosurgery.
About Apollo Endosurgery, Inc.
Apollo Endosurgery, Inc. is a medical technology company focused on development of next-generation, less invasive devices to advance therapeutic endoscopy designed to treat a variety of gastrointestinal conditions including closure of gastrointestinal defects, managing gastrointestinal complications and the treatment of obesity. Apollo's device-based therapies are an alternative to invasive surgical procedures, thus lowering complication rates and reducing total healthcare costs. Apollo's products are offered in over 75 countries today and include the X-Tack™ Endoscopic HeliX Tacking System, the OverStitch™ Endoscopic Suturing System, the OverStitch Sx™ Endoscopic Suturing System, and the ORBERA® Intragastric Balloon.
Apollo's common stock is traded on NASDAQ Global Market under the symbol "APEN". For more information regarding Apollo Endosurgery, go to: www.apolloendo.com.
Cautionary Note on Forward-Looking Statements
Certain statements in this press release are forward-looking statements that are subject to risks and uncertainties that could cause results to be materially different than expectations. In addition, there is uncertainty about the continued spread of the COVID-19 virus and the impact it may have on the Company's operations, the demand for the Company's products, the Company's liquidity position, global supply chains and economic activity in general. Important factors that could cause actual results to differ materially include: reports of adverse events related to our products, outcomes of clinical studies, developments in medical technology, regulatory approvals and extensive regulatory oversight by the FDA or other regulatory bodies, unfavorable media coverage related to our products or related procedures, coverage and reimbursement decisions by private or government payors, physician adoption and recommendations of procedures utilizing our products as well as other factors detailed in Apollo's periodic reports filed with the Securities and Exchange Commission, or SEC, including its Form 10-K for the year ended December 31, 2020 and its Form 10-Q for the period ending June 30, 2021. Copies of reports filed with the SEC are posted on Apollo's website and are available from Apollo without charge. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Apollo disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.
Darrow Associates Investor Relations
Matt Kreps, 214-597-8200
SOURCE: Apollo Endosurgery, Inc.
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