MENLO PARK, Calif., Jan. 5 /PRNewswire/ -- Xtent, Inc., developer of next generation drug-eluting stent systems, announced today that, for the first time in the history of coronary stenting, a single catheter has been used to treat multiple lesions in multiple coronary arteries in a human patient. The company further announced that physicians have treated a second patient with the longest coronary stent of any kind ever delivered with a single catheter. Both breakthroughs represent important milestones in Xtent's CUSTOM II clinical trial, and promise interventional cardiologists greater ability to treat complex coronary disease.
These groundbreaking procedures were performed by Prof. Eberhard Grube, M.D., Chief of Cardiology, Siegburg Heart Center in Siegburg, Germany, and principal investigator for Xtent's CUSTOM II clinical trial. This trial, which began in December 2005, has been designed to evaluate the use of Xtent's drug-eluting stent system for the treatment of long-lesion, multi-lesion and multi-vessel disease -- one of the fastest growing sectors in interventional cardiology.
In one patient with multi-vessel disease, Prof. Grube treated two separate lesions in different arteries during a single insertion of the Xtent system, customizing the length of each stent in situ to match the length of each lesion. First, a stent 28 mm in length was placed in a circumflex obtuse marginal branch artery. Then, without removing the device from the patient, the device was repositioned to deploy a second 32 mm stent in the left anterior descending artery.
In another patient, Prof. Grube delivered a single 52-mm stent, the longest stent ever placed in the coronary arteries from a single catheter.
"The flexibility and trackability of the Xtent device was very impressive. Stent delivery was smooth and precise. Both cases were excellent examples of how one device can easily replace 2 or 3 standard drug eluting stents," said Prof. Grube.
Greg Casciaro, president and CEO of Xtent, added, "These achievements demonstrate a new breadth of application for Xtent's customizable stent delivery technology that will allow cardiologists to treat much more complex disease more quickly and easily, with reduced cost and potentially fewer complications." According to Casciaro, patients with complex disease, who today might receive multiple standard stents delivered separately or who would be referred to bypass surgery, now may be treatable with a single Xtent device.
About The Xtent System
Today, using standard stent technology, cardiologists make pre-procedure estimates of lesion length, and then pick a predetermined stent length for insertion (limited with current technology to lengths of 33 mm or less). This process, recent studies have shown, is prone to error. Moreover, the current approach also necessitates the overlapping of stents to treat long lesions, which also has been shown to increase patient morbidity. Further, since standard approaches require interventionists to exit the patient's cardiovascular system each time they place a stent, multiple stent procedures are lengthy, costly to hospitals and more difficult for the interventionist to perform.
By allowing cardiologists to customize length in situ, however, the Xtent system permits cardiologists, first, to fit the stent to lesion length on the spot and then move on to a second lesion to deliver a second custom-length stent. Similarly, for longer lesions, Xtent stent customization allows cardiologists to exactly meet the patient's requirements, escaping the fixed length limitations of current stents. The flexibility of Xtent's modular stent design also permits the stent to conform to the natural vessel shape as the heart beats and makes it particularly well suited to long lesion treatment.
In all, Xtent's ability to deliver customizable stents will allow cardiologists to deliver multiple customized, drug-eluting stents of highly varying length to several treatment sites with a single catheter. That ability, in turn, has the potential to reduce time, cost, and morbidity compared to current practice.
"In today's era of drug-eluting stents, we are seeing an increased percentage of patients with more complex disease. Such patients have more diffuse disease and often blockages in more than one coronary artery. Since standard drug-eluting stent systems are optimized for single focal lesions, the Xtent DES System is a welcome tool for addressing this large and growing population," said Prof. Grube.
The Custom II clinical trial will eventually enroll 80 patients at up to seven different European centers. Prof. Grube and Xtent completed enrollment of a 30-patient CUSTOM I trial in June 2005 to demonstrate the Xtent system's capability to customize stent length in situ during single lesion procedures. Four-month follow-up results from that trial will be presented at the American College of Cardiology in March 2006. In both trials, the stent is coated with the anti-restenosis drug Biolimus A9(TM) and a bioerodable polymer, which Xtent licensed from Biosensors International Group.
"We are extremely pleased to see our system perform so well in these real- world clinical situations," said Greg Casciaro, Xtent President and CEO. "In the CUSTOM I trial we demonstrated the capability to customize stent length in situ, which had never been done before. Now we build on that achievement with new milestones in multiple lesion and long lesion treatment. Our goal is to provide physicians with devices designed to treat the real patients they see everyday, those with diffuse disease, long lesions, and multiple lesions. These milestones bring us one step closer to achieving that goal."
About Xtent
Xtent is a privately held developer of next generation drug-eluting stent systems designed for the treatment of real-world patients, those with complex, multi-vessel, and multi-lesion coronary and peripheral vascular disease. Based in Menlo Park, California, the company is funded by leading venture capital firms including Advanced Technology Ventures, Latterell Venture Partners, Morgenthaler Ventures, and Split Rock Partners.
Xtent, Inc.CONTACT: Brian Walsh, VP of Sales and Marketing of Xtent, Inc.,+1-650-475-9430, or bwalsh@xtentinc.com; or Tom Gibson of The GibsonNetwork, +1-216-881-9376, or tgibson1@ameritech.net, for Xtent, Inc.
