European Clearance Includes Unstable Angina and Acute Heart Attack
BARCELONA—-Medtronic, Inc., today announced that its Endeavor drug-eluting stent (DES) is the first and only coronary stent to have received CE (Conformité Européene) Mark approval for treating patients with acute coronary syndrome (ACS), which includes unstable angina and acute myocardial infarction (AMI), commonly known as heart attack.
Medtronic is launching the unique ACS indication for the Endeavor DES today at PCR, a large and prestigious international meeting of interventional cardiologists. At this meeting today, Prof. Martin Rothman of the London Chest Hospital in the U.K. released positive new 12-month data from the international real-world registry E-Five study (n=8,314) that show comparable outcomes for Endeavor DES patients with and without ACS .
“Considering the distinctive safety record of the Endeavor stent, this indication for ACS makes perfect sense,” said Prof. Rothman. “Results from the E-Five study support the use of the Endeavor stent in real-world clinical practice, including ACS patients.”
Clinical research shows that ACS patients are at higher risk of stent thrombosis and mortality than non-ACS patients. ACS is a complex disease state for which drug-eluting stents are sometimes avoided due to concerns over long-term safety and patient compliance with antiplatelet medication.
“Of critical importance for safety, the biocompatibility of the Endeavor stent allows rapid and complete healing of the vessel wall,” explained Sean Salmon, vice president and general manager of Medtronic CardioVascular’s Coronary and Peripheral business. “We believe that this healthy healing is the key to long-term safety and efficacy.”
The E-Five study demonstrated no statistically significant difference on the primary endpoint – the rate of major adverse cardiac events (MACE) at one year – between ACS patients (7.8 percent, n=3,973) and non-ACS patients (7.2 percent, n=4,341). Rates of death, MI and late stent thrombosis (LST) at one year were similarly low and comparable between the two groups.
- All-cause mortality – 2.7% ACS, 2.2%, non-ACS
- Cardiac death – 2.0% ACS, 1.5% non-ACS
- MI – 1.8% ACS, 1.5% non-ACS
- Cardiac death + MI – 3.4% ACS, 2.7% non-ACS
- LST (ARC def/prob) – 0.5% ACS, 0.3% non-ACS
Low and similar rates of standard efficacy measures were also observed, including target lesion revascularization (TLR), target vessel revascularization (TVR) and target vessel failure (TVF). On all these measures, there were no statistically significant differences between the ACS and non-ACS groups.
Medtronic’s Endeavor stent originally received the CE mark in August 2005 as a treatment for coronary artery disease. This latest approval enables Medtronic to market the Endeavor DES specifically for ACS patients in the European Union, and all other countries that recognize the CE Mark. These countries do not include the United States or Japan, where the Endeavor DES is also commercially available but is not indicated for ACS patients.
Source: Medtronic
published: May 19, 2009 in: Companies, Medtronic, Products, Regulatory, Specialty