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AngioSculpt Scoring Balloon Catheter Gets PMA For Coronary Artery Disease

This article was originally published in The Gray Sheet

Executive Summary

AngioScore may become an acquisition target for a larger interventional cardiology company following the Jan. 8 FDA approval of its AngioSculpt scoring balloon catheter to treat coronary artery stenosis

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AngioScore in Japan

Firm plans an April launch of its AngioSculpt scoring balloon catheter in Japan for treatment of coronary artery disease, AngioScore announces upon approval in that country Jan. 28. Available in Europe since 2004, AngioSculpt received FDA approval in January 2007 for use in the coronary arteries (1"The Gray Sheet" Jan. 15, 2007, p. 16). According to AngioScore, more than 180,000 interventional procedures are done in Japan each year

AngioScore in Japan

Firm plans an April launch of its AngioSculpt scoring balloon catheter in Japan for treatment of coronary artery disease, AngioScore announces upon approval in that country Jan. 28. Available in Europe since 2004, AngioSculpt received FDA approval in January 2007 for use in the coronary arteries (1"The Gray Sheet" Jan. 15, 2007, p. 16). According to AngioScore, more than 180,000 interventional procedures are done in Japan each year

Financings In Brief

Transoma Medical IPO: Maker of the Sleuth implantable electrocardiogram monitoring system announces Oct. 12 plans for an initial public offering of up to $75 million in common stock. The Sleuth system, which "captures, records, analyzes and wirelessly transmits clinically relevant ECG data," debuted earlier this month following an Oct. 1 510(k) clearance. The system is intended for monitoring patients with clinical syndromes or increased risk of cardiac arrhythmias, as well as patients "who experience transient symptoms that may suggest a cardiac arrhythmia," the firm says (1"The Gray Sheet" Jan. 1, 2007, p. 21). By 2009, Transoma plans to release an enhanced version for diagnosing and monitoring atrial fibrillation. Future generation systems also will enable stratification of patients at risk of sudden cardiac death and long-term monitoring of blood pressure, the firm says. Transoma generated revenue of $37.2 million for the 12 months ended June 30, up 20.5%, based on use of its technology in animal models for biomedical research. Underwriters for the IPO include Piper Jaffray, Thomas Weisel Partners, RBC Capital Markets, Canaccord Adams and BMO Capital Markets

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