--------------------------------------------------------------------------------
Related Quotes
Sym. Price Chg.
GIVN Trade
News 16.72 0.33
Given Imaging Announces Results of Patency System Multi-Center Study
November 06, 2003 07:39:46 (ET)
YOQNEAM, Israel, Nov 06, 2003 /PRNewswire-FirstCall via Comtex/ -- Given Imaging (Nasdaq: GIVN) today announced preliminary results from a multi-center European study presented at the 11th United European Gastrointestinal Week (UEGW) Conference that took place in Madrid, November 1 - 5. A simple prep-less, ingestible procedure, the M2A Patency System is designed to address the need of physicians to verify the presence of obstructing strictures and adhesions in the GI tract.
The study aimed to test the safety and efficacy of an ingestible, biodegradable capsule to verify GI patency. Data presented from the Italian site of the multi-center trial included twenty-two patients with small bowel strictures. Of the twenty-two patients, nineteen had been previously diagnosed with Crohn's disease, while the remainder were diagnosed with adhesion-related strictures and ischemic enteritis. Seven of the twenty-two patients previously underwent a small bowel resection procedure.
Of the twenty-two patients examined, thirteen excreted the M2A(R) Patency Capsule intact, while the M2A(R) Patency Capsule disintegrated in the GI tract of the nine remaining patients. The study also evidences the success of the M2A(R) Patency Capsule in indicating the likelihood of natural passage of the M2A(R) Capsule. When the M2A(R) Patency Capsule indicated patency, the M2A(R) Capsule passed naturally in six out of six cases.
"From the preliminary results of clinical trials that we performed, our conclusion is that the M2A(R) Patency Capsule gives direct indication of functional patency even in cases where SBFT suggests the presence of a stricture. We also found in several cases that when the M2A Patency Capsule is excreted intact, the M2A video capsule can pass uneventfully," said Professor Guido Costamagna of the Digestive Endoscopy Unit, Catholic University, Rome, Italy. "We can conclude that the M2A Patency Capsule is a simple, safe, radiation-free minimally-invasive diagnostic tool."
The Patency System consists of [1] an ingestible, dissolvable capsule that is the same size as the M2A Capsule Endoscope (26 mm long, 11 mm diameter) with a tiny Radio Frequency ID (RFID) tag and [2] a hand-held scanner used to determine a signal from the RFID tag. Additionally, the capsule contains barium, so that in those instances where the capsule is not excreted after ingestion, the physician may detect the presence of the Patency Capsule within the body with the hand-held scanner, and then, also determine the exact location of the obstruction under fluoroscopy. If obstructed, the Patency Capsule is designed to dissolve after two to three days and pass naturally.
Given Imaging's patency system has received the CE-Mark which allows it to be marketed throughout the European Union.
About Given Imaging
Given Imaging develops, produces and markets the Given(R) Diagnostic System featuring the M2A(R) Capsule Endoscope, the only non-invasive method for direct visualization of the entire small intestine. The system uses a disposable miniature video camera contained in a capsule, which is ingested by the patient. The M2A capsule passes naturally through the digestive tract, transmitting high quality color images, without interfering with the patient's normal activities. The system received clearance from the FDA in August 2001 and received permission to affix the CE mark in May 2001. Distribution channels for the system have been established in more than 50 countries worldwide. More than 50,000 capsules have been used in clinical practice. Thousands of patients around the world have benefited from the M2A which has been used to diagnose a range of diseases of the small intestine including Crohn's Disease, Celiac disease and other malabsorption disorders, benign and malignant tumors of the small intestine, vascular disorders, medication related small bowel injury, as well as a range of pediatric small bowel disorders. For more information, visit givenimaging.com.
This press release contains forward-looking statements about Given Imaging, including projections about our business, our future revenues, and our future profitability, within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, statements in the future tense, words such as "anticipates," "estimates," "expects," "intends," "plans," "believes," and words and terms of similar substance used in connection with any discussion of future operating or financial performance identify such forward-looking statements. Those forward-looking statements are not guarantees of future performance and actual results could differ materially from our current expectations as a result of numerous factors, including but not limited to the following: changes in regulatory environment, our success in implementing our sales, marketing and manufacturing plan, protection and validity of patents and other intellectual property rights, the impact of currency exchange rates, the effect of competition by other companies, the outcome of future litigation, the reimbursement policies for our product from healthcare payors, quarterly variations in operating results, the possibility of armed conflict or civil or military unrest in Israel and other risks disclosed in our filings with the U.S. Securities Exchange Commission.
SOURCE Given Imaging |
