Key Developments For Angiotech Pharmaceuticals, Inc.
Angiotech Pharmaceuticals, Inc. (ANPI.O) (Nasdaq)
Angiotech Pharmaceuticals, Inc. Announces Commercial Launch Of Tan Endoglide Endothelium Insertion System
Angiotech Pharmaceuticals, Inc. announced the commercial launch of the Tan EndoGlide Endothelium Insertion System in the United States. Angiotech holds exclusive U.S. distribution rights to market and distribute the Tan EndoGlide Endothelium Insertion System, which it obtained in a supply agreement with privately held Network Medical Products, Ltd.
Angiotech Pharmaceuticals, Inc. Provides Update On Bio-Seal 510(K) Submission
Angiotech Pharmaceuticals, Inc. announced that it has received correspondence from the FDA regarding its 510(k) submission for Bio-Seal, stating that Bio-Seal is a class III device that requires Pre-Market Approval (PMA) for FDA marketing clearance. As a result, Angiotech is reviewing its options with respect to this product candidate, including possibly appealing this FDA decision, and is discussing the possible preparation of a PMA submission with its partner, Biopsy Sciences, LLC.
Angiotech Pharmaceuticals, Inc. Announces TAXUS Liberte Stent Continues To Demonstrate Significant Improvements Over TAXUS Express Stent In Small Vessels And Long Lesions
Angiotech Pharmaceuticals, Inc. announced that its corporate partner, Boston Scientific Corporation has released comprehensive data from the TAXUS ATLAS clinical program, a series of global, prospective, single arm trials evaluating the TAXUS Liberte Paclitaxel Eluting Stent System in a variety of lesions and patient groups. Three year results from the TAXUS ATLAS Small Vessel and Long Lesion Trials continue to show significant advantages for the newer TAXUS Liberte Stent when compared to the first generation TAXUS Express Stent. The data were presented at the 21st annual Cardiovascular Research Foundation's (CRF) annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco. Three year results from the TAXUS ATLAS Small Vessel Trial demonstrated a statistically significant reduction in the rate of Target Lesion Revascularization (TLR) in small vessels treated with the TAXUS Liberte Atom Stent as compared to the TAXUS Express Atom Stent (10.0% vs. 22.1%, p=0.008), representing a 55% relative risk reduction. Additionally, the three year MACE rate for the TAXUS Liberte Atom Stent was 19.5% as compared to 32.4% for the TAXUS Express Atom Stent (p=0.03), a relative reduction of 40%. The composite safety measure of cardiac death or myocardial infarction (MI, commonly referred to as heart attack) remained numerically lower at three years for the TAXUS Liberte Atom Stent as compared to the TAXUS Express Atom Stent (6.5% vs. 7.4%, p=0.79).
Angiotech Pharmaceuticals, Inc.'s Corporate Partner Boston Scientific, Reports 2 Year SYNTAX Data Showing Comparable Safety Outcomes
Angiotech Pharmaceuticals, Inc. announced that its corporate partner, Boston Scientific, has reported two-year data from its SYNTAX clinical trial comparing percutaneous coronary intervention (PCI) using the Taxus Express Paclitaxel-Eluting Coronary Stent System to coronary artery bypass graft (CABG) surgery. The overall results demonstrated no statistically significant difference between PCI and CABG in the composite safety endpoint (all-cause death, stroke and myocardial infarction (MI)). The results showed comparable safety profiles for the two treatment groups at two years, with a combined rate of all-cause death, stroke and MI of 10.8% for PCI and 9.6% for CABG (p=0.44). The rate of stroke was 1.4% for PCI as compared to 2.8% for CABG (p=0.03), while MI was 5.9% for PCI and 3.3% for CABG (p=0.01). The rate of all-cause death was 6.2% for PCI and 4.9% for CABG (p=0.24). Overall MACCE (Major Adverse Cardiovascular or Cerebrovascular Event rate, including all-cause death, stroke, MI and repeat revascularization) was significantly higher for PCI (23.3% as compared to 16.4% for CABG, p=0.0002), driven largely by the anticipated higher rate of revascularization in the PCI group (17.4% as compared to 8.6% for CABG, p(less than)0.0001), with the difference narrowing in the second year of follow-up. Most patients requiring repeat revascularization in the PCI group were successfully treated with another PCI.
Angiotech Pharmaceuticals, Inc. Announces Commercial Launch of Option Inferior Vena Cava Filter In United States
Angiotech Pharmaceuticals, Inc. announced the commercial launch of the Option Inferior Vena Cava (IVC) Filter in the United States, following FDA 510(k) clearance in June and a limited pre-launch in July.
