Press Releases

» Optiphase Wins $1M Biomedical Order

Van Nuys, CA —January 12, 2004— Optiphase, Inc. announced today that it has been awarded a $1,000,000 plus order by the biomedical firm IntraLuminal Therapeutics, Inc. to produce the optical assembly used to power its second generation Safe-Cross® fiber optic guidance and control system allowing cardiologists to cross and recanalize coronary and peripheral artery total occlusions.  FDA clearance was obtained in January 2004 for a U.S. market roll-out.  Shipments by Optiphase are slated to begin 2Q2004.  The system is also currently selectively marketed in Europe and Asia.

Optiphase is a developer and manufacturer of high-performance, cost-effective  fiber optic and electronic instruments, assemblies and components serving a variety of fiber sensor markets and applications.  Intraluminal Therapeutics is a medical device company focused on developing a platform of products for the interventional cardiologist and radiologist to cross and recanalize totally occluded arteries by state-of-the-art navigation and micro-ablation technologies, a new frontier in intravascular medicine.

Optiphase and IntraLuminal Therapeutics, pioneers in the development of safe fiber-optic based interventional vascular systems, partnered in the development of ILT’s first generation Safe-Steer® Total Occlusion system.  ILT accelerated its second generation system, the Safe-Cross® Total Occlusion Cross System based on the successful results of the GRIP and GREAT clinical studies involving 188 patients treated in 35 clinical institutions

“The result of our joint efforts and partnership represent a major step forward in the commercialization and use of white-light interferometry in the safe treatment of minimally invasive procedures of major health conditions for thousands of patients” said Mike Weinstock, Optiphase’s Executive Vice President of the ILT relationship.

Optiphase’s optical assembly is an all-fiber white-light scanning Michelson interferometer based technology.  It is a scanning assembly with the broadband source operating at a wavelength of 1310 nm, envelope detection and modulator drive electronics contained within a small rugged enclosure.  Two external fiber leads are provided for connection to the user developed probe and reference fibers that complete the interferometer.  The unit has also been optimized for the demanding high-reliability requirements, varying temperature ranges and scanning devoid of ghost images. 

“The Optical Coherent Reflectometry [OCR] technology from Optiphase, combined with the proprietary IntraLuminal Radio Frequency and guide wire technology, has led to the development of the only intelligent guide wire system which combining guidance, power and steerability.  This technology will enable the interventional specialist to improve treatment options for this difficult lesion subset.” said Carlo de la Mata, Director of Marketing for ILT.  The OCR system measures the reflectivity of a beam of near infrared light that travels down the center of a crossing guide wire and out the distal portion of the wire. The light is then scanned across the blockage and returned via the same path to be analyzed and shown on an easy-to-use monitor screen. This gives the interventionist an early warning when nearing the arterial wall and assists the physician to safely redirect the crossing wire for safe passage through the blockage. 

The Safe-Cross® system combines the Safe-Steer guidance with a therapeutic radio frequency (RF) energy source for crossing highly calcified total occlusions. Micro-ablation occurs at the tip of the guide wire only. The OCR technology is used for safe navigation of the guide wire and prevents micro-ablation from occurring when the tip of the wire is near the arterial wall.  IntraLuminal has successfully completed both coronary and peripheral trials and received FDA clearance in January 2004. 

Founded in 1990, Optiphase, Inc. is a leading provider of interferometric fiber optic sensor solutions for a wide range of applications including Biomedical, Chemical, Industrial, Geophysical and Security industries.  The company offers a complete line of fiber-optic based Instruments, Test Equipment and Assemblies for the scientific and technical community.  In addition to it’s own line of Instruments, Optiphase offers design services and products for custom OEM applications.

 

» For more information on IntraLuminal Therapeutics:

http://www.intraluminal.com

» For more information, contact:

Jeff Bush
818-782-0997 x110
jbush@optiphase.com

Mike Weinstock
818-782-0997 x122
mweinstock@optiphase.com