Medical Device Daily

In Greek mythology Tantalus was a greedy man who disobeyed the orders of the gods by offering them a false sacrifice: a meal — in the form of his own son. As a result of his transgression, whenever Tantalus tried to eat any food or drink any water they would recede from his grasp.

Neophyte med-tech company MetaCure (Orangeburg, New York) is well aware of the troubles of Tantalus and is tapping into the story with the launch of its new gastric stimulator that plays off of this myth.

The device's name -- you guessed it -- Tantalus.

But instead of a story about increasing the appetite, this Tantalus wants to produce stories about decreasing it.

"This is an implantable device under the skin, and it detects whenever someone takes a meal," Naji Abumrad, MD, medical director of MetaCure told Medical Device Daily. "Once a person takes the meal it sends a stimulus to the stomach. The contractions are so strong it makes the stomach feel full. The hope is that it will control glycemic levels in the body."

The system is based on technology called Gastric Contractility Modulation designed to sense naturally occurring electrical activity of the stomach in real time and apply electrical stimulation treatment during meal times.

The company reported yesterday that it is launching an investigational study of this new gastric stimulator technology for patients with Type 2 Diabetes who are overweight.

The trial is slated to have a total of 300 patients.

Tantalus is comprised of a pulse generator, which is the size of a nano-Ipod or a pacemaker, and leads that are implanted through a minimally invasive laparoscopic procedure that can be performed in about an hour, according to Metacure. The leads, through which the electric pulses are delivered, are implanted in the gastric muscle, and the implantable pulse generator is implanted in a subcutaneous pocket in the belly. The entire device weighs about 75 grams.

It also comes with external control and monitoring components for the patient and physician. The device data can be read non-invasively by the physician for further tailoring of the treatment parameters to the patient.

Abumrad and John Sawyers, professor of surgery and chairman of the department of surgery at Vanderbilt University Medical Center (Nashville, Tennessee), said in a joint statement: "We are excited to have this trial underway as a potential alternative treatment for patients where we have been unsuccessful in managing their type 2 diabetes and weight."

To be considered for the trial, patients must meet certain inclusion criteria, including a diagnosis of Type 2 diabetes with a body mass index (BMI) between 28 and 45kg/m2 and be between ages 18 and 70.

Glandular Diseases Center (San Antonio, Texas) is the first trial site to enroll patients. As of Tuesday four patients were enrolled in the trail -- with that number changing daily, according to Abumrad.

Plans call for submission of the device to the FDA for approval at the end of 2009 and U.S. commercial launch in 2010. Tantalus was given CE mark approval in 2006, according to Shai Policker, VP of business and development at MediCure.

Tantalus "is available to patients in Europe for the indication to treat Type 2 diabetes with obesity. It has been clinically evaluated in more than 100 patients worldwide," said Irit Yaniv, COO of Metacure. "We look forward to potentially being able to make it accessible in the future to U.S. patients as well."

The company was founded in 2003 to develop therapies to treat diabetes.

Type 2 diabetes is a metabolic disease primarily characterized by relative insulin deficiency, and hyperglycemia. It is often managed by exercise and diet modification.

Some 90% to 95% of all North American cases of diabetes are Type 2, and about 20% of the population over the age of 65 has Type 2 diabetes.

The fraction of Type 2 diabetics in other parts of the world varies substantially, almost certainly for environmental and lifestyle reasons, though these are not known in detail. Diabetes affects more 150 million people worldwide, and this number is expected to double by 2025.