Xtent Inc., developer of a drug-eluting stent delivery system that for the first time permits interventional cardiologists to customise stent length to match patient lesions, disclosed preliminary results from its groundbreaking first-in- man trial.

Professor Eberhard Grube, of the Heart Center Siegburg, Germany, presented the data to the Cardiovascular Research Foundation's (CRF) Seventeenth Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington D.C. Professor Grube is principal investigator for the multi-center Custom I trial, in which 30 patients with arterial lesions were treated in June 2005.

Preliminary results from the cohort with four-month follow-up demonstrated excellent clinical and angiographic outcomes. Earlier in the week, Professor Grube performed a diagnostic follow-up from the trial in Siegburg and transmitted the case live to an assembled TCT audience, states a company release.

"The performance of the Xtent DES System during the Custom I trial exceeded all of our expectations. The device was straightforward to use, highly deliverable and allowed for very accurate treatment of complex coronary lesions. The Xtent device has been an exciting addition to our armamentarium," said Professor Grube.

The release further informs that the Xtent system allows the cardiologist to first deliver the stent to the artery, then determine in situ what length would best span the target lesion between healthy segments of normal vessel. The cardiologist then detaches the correct length stent and with the integrated balloon expands the stent to open up the artery lumen for treatment. The Xtent System used in the FIM trials enabled custom placement of up to 36 mm of stent length. Xtent has also designed an expanded version that can deliver up to 60mm of customisable stent. This system is designed to allow the clinician to customise the treatment of multiple lesions or long lesions with a single catheter. The Xtent 60mm version is intended for today's typical patient population of more diffuse and complex multi-lesion disease.

"The Xtent system has been designed to take the guesswork out of stent placement and reduce procedure time and cost.This represents a major advance. Studies presented at TCT last year and this show that current drug eluting stent delivery systems can lead to misplacement greater than 40%, a problem Xtent's system will virtually eliminate. In addition, the Xtent system allows cardiologists to treat longer, more diffuse lesions without having to resort to overlapping multiple stents which have been shown to be a predictor of adverse events," said Greg Casiaro, president and CEO, Xtent.

Xtent is a privately held developer of drug-eluting stent systems for the treatment of complex, multi-vessel, multi-lesion coronary and peripheral vascular disease.