Design: Single arm registry, Pharmacokinetics

Primary endpoint: BA9™ concentration at 30 days and 6 months.

Design: Randomized, Multicenter clinical trial - BioMatrix™ vs. Gazelle™* (2:1)

Primary endpoint: In-stent Late Loss at 6 months.

Results: 0.09 vs 0.48 mm (p < 0.01)

Design: Multicenter Single Arm Registry

Primary endpoint: TVR at 6 months.

Results: 2.1%

Design: Randomized, Multicenter All-Comers Clinical Trial.

BioMatrix Flex™ vs. Cypher© Select™

Primary endpoint: CV death, MI, clinically-indicated, TVR at 9 months

Results: 9.2% vs 10.5% (P non-inferiority = 0.003)

Sub-group of the LEADERS trial - OCT (Optical Coherence Tomography)

Design: Multicenter Single Arm Post Market Registry

MACE defined as Cardiac Death, Ischemic Driven MI

(Q-wave and NQ-wave) and Ischemic Driven TLR (PTCA and CABG)

Primary endpoint: MACE at 12 months

Follow-up of 30 days, 90 days, 6, 12 months, 2-5 years

Enrollment completed in December 2008.

Design: Multicenter Single Arm Post Market Registry

PMS: n =1122 - 100% monitoring

PMR: n =4000 - 100% monitoring of adverse events

MACE defined as Cardiac Death, MI (Q-wave and NQ-wave), or justified TVR

Primary endpoint: MACE at 12 months.

Follow-up of 30 days, 12 months and 2-5 years

Design: Multicenter Single Arm Post Market Registry

PMD: n=1100 - 100% monitoring

PMR: n=4000 - 100% monitoring of adverse events

MACE defined as Cardiac Death, MI (Q-wave and NQ-wave), or justified TVR

Primary endpoint: MACE at 12 months

Follow-up of 30 days, 12 months and 2-5 years

Design: Randomized 3-arm safety and effectiveness study with a follow-up of 30 days, 4 months, 12 months and 2-5 years.
Primary endpoint: In-stent late loss at 12 months.