Initial Results of PROGRESS–AMS Study Confirm
Safety and Feasibility
of Absorbable Metal Stent Technology in Human Coronary Vessels
Buelach, Switzerland, March 10, 2006 -- Four months after the implantation of BIOTRONIK’s Absorbable
Metal Stent (AMS) in 63 patients to treat single de novo lesions in a native coronary artery, the
PROGRESS-AMS study has demonstrated the safety and feasibility of the AMS technology. Future
trials will be required to validate efficacy of the AMS technology in coronary arteries.
This first worldwide coronary study was a prospective, multicenter, consecutive, non-randomized
investigation in 8 international clinical sites. This study was designed to evaluate the safety,
feasibility, and efficacy of the AMS system. After 4 months, the study results demonstrate the
feasibility of delivering the AMS to coronary arteries and the safety of the technology, which showed
no cardiac deaths, no nonfatal myocardial infarctions, and no cases of stent thrombosis. The trial
revealed minimal neointimal growth. The study confirmed the complete degradation of the stent
through intravascular ultrasound ( IVUS ) follow-up. In addition, one of the main advantages of the
technology - that it is completely MRI compatible - was confirmed during the course of the trial,
making the AMS the first technology to provide physicians with the opportunity for non-invasive
follow-ups throughout the course of treatment to their patients. The trial did reveal a rate of
restenosis that is not yet in line with clinical standards, a point which is being addressed by finetuning
the AMS technology. Results from those efforts will be confirmed in future coronary efficacy
trials.
“The AMS is not just another stent. It represents a revolutionary leap forward in vascular
intervention treatment. The AMS provides the necessary short term scaffolding needed to support
the vessel during the healing process and is then absorbed, avoiding the long-term mechanical
stress of current permanent stent technologies,” said Professor Raimund Erbel, Principal
Investigator of the PROGRESS-AMS trial. “The PROGRESS-AMS study demonstrates the viability
of the AMS technology in coronary arteries and the need for continued “fine tuning” of this
revolutionary technology to meet the demands of the coronary environment. It is important to keep
in mind that the AMS technology is a new frontier in treatment and the AMS clinical trial process is
designed to help us determine optimum degradation times for the various uses of the AMS. There is
strong evidence to suggest that the increased demands of a moving heart and cyclic load found in
the more muscular coronary arteries require a different stent degradation rate than that of
peripheral arteries. By fine-tuning the AMS degradation rate to optimize mechanical performance
over time, the AMS should achieve coronary results similar to the very positive results the system
achieved in earlier animal and human peripheral studies. Eventually, this will lead to an entire new
field of absorbable treatments that will establish a new standard in patient care.”
“The PROGRESS-AMS trial provides continued proof of concept of the AMS system. We are
pleased with the safety profile of the Mg stent in the first human clinical trials and recognize the
potential of this revolutionary technology which signifies a quantum leap forward in vascular
intervention treatment,” commented Claus Martini, CEO of BIOTRONIK Vascular Intervention.
“ We are also encouraged by the long term results of our first peripheral application for the Mg
bioabsorbable stent which demonstrated not only safety but also efficacy. Biotronik Vascular is
committed to continued R&D efforts to perfect the absorbable Mg stent and bring it to clinical
practice both for peripheral and coronary applications.”
About BIOTRONIK GmbH & CO.
BIOTRONIK GmbH & CO. is a leading European manufacturer of medical technology
with a worldwide market presence. The company offers a complete line of products
for diagnosis,
treatment and advanced therapy support in the areas of cardiac rhythm management,
electrophysiology and vascular intervention. The vascular intervention portfolio
comprises of guide wires, balloon catheters and stent systems for coronary and
peripheral applications. The company
just launched its first Drug Eluting Stent device, CoStar™, through
its distribution agreement with Conor Medsystems and is successfully continuing
the clinical investigation of its AMS technology in
both coronary and peripheral indications.
For more information please visit, www.biotronik.com/vi, or contact:
Marlou Janssen
Vice President, Sales & Marketing
Vascular Intervention
Biotronik AG
Ackerstrasse 6
CH - 8180 Buelach / Switzerland
Phone +41 (0)1 864 51 94
Fax +41 (0)1 864 51 30
Source: Biotronik AG |
