LightLab's cardiac OCT progress sets stage for new developments

JANUARY 7, 2009--LightLab Imaging (Westford, MA), producer of optical coherence tomography (OCT) systems for diagnosing and treating heart disease, reports installation of >300 OCT systems in 20 countries, a 45% increase in per-system catheter use, >10,000 imaging procedures performed, and status as "the only reimbursed intravascular OCT imaging product in the world." The company will soon announce a major clinical study in the US.

JANUARY 7, 2009--LightLab Imaging Inc. (Westford, MA) says its 2008 developments are the culmination of the company's sustained clinical and technology investment--and the effect is an enhanced leadership position in intravascular optical coherence tomography (OCT). The company reports that it's installed more than 300 OCT systems in 20 countries, a 45% increase in per-system catheter use, and more than 10,000 imaging procedures performed. LightLab is using its proprietary technology to design, manufacture and sell OCT systems that aid interventional cardiologists in the diagnosis and treatment of coronary artery disease.

As of December 31, 2008, Light Lab has placed more than 300 M2 and M2x systems in 20 countries in Europe, Asia, the Middle East and South America. Per-system catheter utilization increased 45% in 2008 over 2007, and the number of imaging catheters sold in 2008 increased 90% from 2007 levels. The number of clinical OCT procedures using LightLab Imaging OCT systems has now surpassed 10,000, providing LightLab with "unsurpassed 'real-world' experience with OCT," the company reports.

"During 2008, we continued to execute strategies that will further extend our leadership position in the year ahead," said David Kolstad, LightLab Imaging's President and CEO. "Among them, we expect to shortly announce the initiation of patient enrollment in a major clinical study of our intravascular OCT system here in the United States. In addition, in October we became the only reimbursed intravascular OCT imaging product in the world when we received a favorable reimbursement coverage decision from the Japanese Ministry of Health, Labor and Welfare that provided OCT payment at a level above IVUS."

LightLab reports that OCT is rapidly becoming indispensable in the evaluation of coronary stents. In November 2008, OCT was recognized in a special meeting article in the European Heart Journal in which the European Society of Cardiology and the European Association for Percutaneous Cardiovascular Interventions together with European regulatory bodies recommended OCT as a modality for assessing stent coverage and neointima formation in clinical studies designed to support regulatory submissions for new stents in Europe.

During 2008, clinicians deployed LightLab's M2 and M2x OCT imaging systems in critically important clinical studies. For instance, all OCT images acquired in the Horizons AMI OCT data study, presented at the 2008 American Heart Association Congress, were generated using LightLab Imaging OCT systems. At TCT in October, LightLab Imaging OCT systems were used in 30 clinical presentations and 18 abstracts, more than 3 times the number of presentations and abstracts than all other competitors combined. A number of additional important studies are expected in the coming year, further establishing the important role of OCT in interventional cardiology.

"We have exciting plans for 2009, in cardiology and other applications. We continue to build on our proprietary technology platform and leadership position, with increased levels of investment ensuring that our OCT offerings remain the products and services of choice by the world's foremost clinicians," added Kolstad.

More information:
LightLab Imaging Inc.

Posted by Barbara G. Goode, barbarag@pennwell.com.

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