Spectranetics Enrolls First Patients in TAAMI Trial

Spectranetics Corporation (Nasdaq:SPNC) announced today enrollment of the first patients into the TAAMI trial. The TAAMI trial (ThromboAblation in Acute Myocardial Infarction) is a planned 200-patient randomized trial involving major medical centers in Poland. Starting last quarter, TAAMI enrolled its first six patients and recently initiated the fifth participating hospital. The trial comprises two treatment groups and enrolls the most complex AMI patients – those with a large thrombus burden presenting with ST wave elevation myocardial infarction (STEMI). The study group receives excimer laser treatment plus direct stenting. The control group receives balloon angioplasty and stenting. The primary endpoint is a combination of ST resolution, which is resolution of the EKG ST wave elevation injury pattern and the amount of distal embolization as measured by myocardial blush scores. "The TAAMI trial represents an important new opportunity for Spectranetics to evaluate the performance of the excimer laser in these AMI patients,” said John G. Schulte, Spectranetics’ President and Chief Executive Officer. The principal investigator of the TAAMI trial, and a leading cardiologist at the Jagiellonian University Medical Center of Krakow, Dariusz Dudek, MD, PhD stated, "This trial will help to assess the effectiveness of laser treatment in conjunction with stenting, and in comparison with a common current combination treatment. I believe this is an important step forward in improving the treatment of patients with AMI.” A similar trial conducted in Italy by V. Ambrosini and associates was recently published February 15, 2008 online as an Article in Press of the International Journal of Cardiology. This study describes favorable results seen using the Company’s excimer laser to treat 66 patients presenting with AMI complicated by persistent thrombotic occlusion. The article titled "Excimer laser in acute myocardial infarction: Single centre experience on 66 patients,” concludes that "Laser angioplasty is feasible, safe and effective for the challenging treatment of patients with AMI and thrombus-laden lesions. The acute effects on coronary epicardial and myocardial reperfusion are excellent.” The trial enrolled patients between May 2003 and October 2006. The primary acute angiographic endpoint was corrected TIMI frame count; the secondary echocardiographic endpoint was left ventricular remodeling defined as an increase in end-diastolic volume = 20% 6 months after infarction; and the tertiary endpoint was event-free survival at the 6 month follow-up. According to the article, laser treatment is associated with excellent acute angiographic coronary and myocardial reperfusion as assessed by blush score and corrected TIMI frame count. The article’s authors also observed a relatively high rate of ST segment resolution at 90 minutes after procedure and a low incidence of long-term ventricular remodeling. Finally, the article noted there was 95% event-free survival at the 6 month follow-up. However, the authors do point out that further randomized, multicenter controlled trials are warranted in order to assess the benefits of laser angioplasty versus conventional treatment in AMI. "We are very encouraged by the results described in the International Journal of Cardiology,” said Schulte. "The endpoints documented in the article are consistent with the clinical goals of the TAAMI trial, and the reported results support our decision to move forward with our own randomized trial.” About Spectranetics Founded in 1984, Spectranetics manufactures and sells the only excimer laser approved in the United States, Europe and Japan for use in minimally invasive cardiovascular procedures. This technology treats complex cardiovascular conditions by photo-ablating multiple lesion types into tiny particles that are easily absorbed into the blood stream. The Company’s disposable catheters use high-energy "cool” ultraviolet light to vaporize arterial blockages in the legs and heart, as well as scar tissue encapsulating pacing and defibrillation leads. For more information visit www.spectranetics.com.