Bolton Medical reports first U.S. trial of its Relay Plus System for endovascular stent-graft procedures

Bolton Medical announced today the first use of its new Relay Plus System in the U.S. Relay Clinical Trial. The case took place at the University of Pennsylvania Medical Center in Philadelphia, PA.

Dr. Nimesh D. Desai noted that the surgery was successful and the Relay Plus System allowed for easier access to the difficult-to-reach thoracic aorta. He further commented that "the hydrophilic dual-sheath design in the Relay Plus makes this device highly versatile in terms of tight access vessels, and the additional sheath length provides better stability during graft deployment."

"The Relay Plus System has a spiral support bar which allows the graft to take the lesser curve without kinking and eliminates the notion of 'bird-beaking' gaps and 'no-man's land'. The system also has smaller caliber devices (22 mm) which allows for repair of patients with smaller diameter aortas," said Dr. Grace J. Wang.

Thoracic Stent-Grafts are an option to traditional open surgery for patients requiring treatment for main thoracic pathologies. The endovascular stent-graft procedure generally results in a reduced hospital stay and a shorter recovery time for the patient.

The Relay Plus System offers new delivery system features to optimize navigation and is designed for use with the Relay Thoracic Stent-Graft. It was developed with feedback from participating physicians and offers the following attributes:

-- Hydrophilic coating on the outer sheath and tip for easier introduction and advancement through the aorta -- Longer 60 cm braided outer sheath with enhanced radiopacity and reinforced pushrod to facilitate pushability and visibility in challenging aortic anatomies -- New nitinol inner catheter to aid in the alignment of the dual sheath system -- Streamlined tip-sheath transition

Study Investigator Dr. Wilson Szeto stated, "I've had fantastic results from the Relay trial. Here at UPENN, we've had no mortalities, no stroke rate, and no vascular complications during the 2.5 years we've participated in the trial. Bolton Medical has really fine-tuned the lessons learned from other TAA products and incorporated them into a great product."

The two University of Pennsylvania surgeons who performed the procedure were Dr. Nimesh D. Desai of the Division of Cardiovascular Surgery, and Dr. Grace J. Wang of the Division of Vascular and Endovascular Surgery. The Study Investigator at UPENN for the Relay Clinical Trial is Dr. Wilson Szeto of the Division of Cardiovascular Surgery.

The Relay Plus System was CE marked in March of 2009 and is available in Europe as well as countries worldwide that recognize the CE mark. It will be marketed along with the original Relay Thoracic Stent-Graft System which was launched in Europe in 2005 and is well underway in clinical trials in the U.S.

Relay and Relay NBS Thoracic Stent-Grafts are indicated for the treatment of main thoracic aortic pathologies such as aneurysms, penetrating ulcers, pseudoaneurysms, and intramural hematomas in adult patients. It is expected that by the end of 2009 more than 3500 Relay and Relay NBS Stent-Grafts will have been implanted worldwide.