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AngioLight Completes Animal Study at Fu Wai Hospital; Begins Preparing for China Food and Drug Administration (CFDA) Regulatory Testing

2013年06月06日 PM08:25
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MEDFORD, Mass.

AngioLight, an early stage, pre-clinical interventional cardiovascular medical device company, has successfully completed an initial animal study of the AngioLight System at Fu Wai Hospital, a leading cardiovascular center located in Beijing. The study paves the way for AngioLight to go forward in China with full-scale animal and clinical testing of the system, which will begin following the anticipated completion of study protocols, hospital review and required China Food and Drug Administration (CFDA) approvals.

The AngioLight System is a novel light-based diagnostic catheter designed to provide interventional cardiologists and radiologists with vessel diameter and area measurements that will help improve proper stent sizing and placement, which studies have shown can improve outcomes for patients. The device has been designed with the goal of delivering diagnostic data beyond the capability of fluoroscopy and at a fraction of the cost of vascular imaging modalities such as intravascular ultrasound (IVUS) and optical coherence tomography (OCT).

“The initial studies have shown that the AngioLight System can quickly and easily provide advanced diagnostic information to physicians that may enable better patient outcomes,” said Ge Bai, managing director of Medical Technologies Innovation Asia (MTIA), Hong Kong, AngioLight’s strategic partner responsible for completing safety, animal and clinical studies of the AngioLight System in China. “We believe this technology has widespread application in China and beyond in vascular stenting and other interventional procedures.”

The market for AngioLight’s technology is significant. Within the interventional cardiology market alone, stenting and angioplasty represent $12 billion worldwide. All indications point to continued growth, particularly in China, where interventional cardiology procedures are rising rapidly and the adoption of IVUS and OCT has been limited.

“The results of the Fu Wai study have demonstrated significant additional validation for the AngioLight System and have provided us with a clear path forward,” said Gary Saxton, AngioLight president. “We are eager to proceed with MTIA through the regulatory process and into commercialization, first in China and then into other worldwide markets.”

About Medical Technologies Innovation Asia

Medical Technologies Innovation Asia (MTIA) is a fully integrated medical device company focused on delivering game-changing technologies that improve existing standards of care. Headquartered in Hong Kong, the company has manufacturing and sales facilities throughout mainland China. MTIA has established sales channels in more than 1,000 hospitals across China’s provinces, including national, top-tier regional and military institutions.

About AngioLight Inc.

Based in Medford, Mass., AngioLight is an interventional cardiology medical device company founded to address unmet clinical needs in coronary and peripheral stenting. The company has developed a novel light-based diagnostic catheter to improve proper stent sizing and placement, and ultimately, patient outcomes. For more information, visit www.angiolight.com.

CONTACT

Nobles Global Communications
Laura Nobles, 310-795-0497
laura@noblesgc.com

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