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ENDOSONICS VISIONS F/X DIAGNOSTIC CATHETER U.S. INTRODUCTION

This article was originally published in The Gray Sheet

Executive Summary

ENDOSONICS VISIONS F/X DIAGNOSTIC CATHETER U.S. INTRODUCTION is scheduled for "late in the second quarter" of 1993, CEO Michael Henson declared Feb. 4 at the Piper, Jaffray cardiovascular conference in New York City. Endosonics plans to introduce the Visions F/X to international markets in the third quarter, Henson said. The company received FDA approval to market the ultrasound catheter on Feb. 1. The Visions F/X is a "monorail" version of the firm's Visions diagnostic imaging catheter. The design enables the device "to traverse the arterial anatomy of the heart over a conventional coronary guidewire in a monorail procedure rather than the traditional 'over-the-wire' procedure," according to a Feb. 2 press release announcing FDA approval of the product. The Visions F/X catheter "provides Endosonics an opportunity to expand the application of our technology to a broader patient population," Henson said in the release. "The advanced catheter materials and engineering used in the Visions F/X form a new technical foundation for Endosonics to design future...catheter products." In April 1993, Endosonics expects to introduce a second product, the AIM 1 advanced image management system, Henson indicated at the conference. The system "improves our image quality by about 50%," he stated. The device is in beta site testing at five locations, with approximately 50 patients treated to date. Clinical data on Endosonics' Oracle and Oracle-Micro ultrasound catheters, which combine imaging and angioplasty capabilities, also were discussed by Henson. The company has submitted data for a premarket approval application for the Oracle-Micro and submitted additional data on a PMA for the Oracle in November 1992. FDA requested the Oracle data in August ("The Gray Sheet" August 24, 1992, In Brief); the PMA was filed in March 1992. According to Henson, FDA required Endosonics to demonstrate "the clinical value of intravascular ultrasound" by answering three questions: can the Oracle and Oracle-Micro "perform angioplasty as well as" other angioplasty products on the market; does the post-procedure Oracle image change physicians' "impression of the results of the angioplasty"; and do physicians "do something different" in surgery based on the Oracle image. The Oracle and Oracle-Micro data submitted to FDA "show that...the device can do balloon angioplasty the same...as any product on the market," Henson stated. Discussing the other two FDA questions, Henson said that 23% of the physicians using the Oracle catheter said their impression of angioplasty results changed "based on this [Oracle] image." The angioplasty procedure was altered in 12% of the patients as a result of scanning with the Oracle. The Oracle-Micro data are "much more compelling," Henson stated. In 50% of the patients studied, physicians said their impression of angioplasty results had changed, while the surgical procedure was altered in 29% of the patients. On Jan. 27, Endosonics announced a product development pact with Philips Medical Systems. The companies agreed to "develop the hardware and software programs required to integrate the display of Endosonics catheter-based [ultrasound] imaging technology with the x-ray angiographic images provided by Philips medical imaging equipment," according to an Endosonics release. When completed, the integrated imaging system will be capable of displaying Endosonics ultrasound images and Philips angiographic images via the same video monitoring system, Endosonics says. The product integration "will provide cardiologists greater access to the intravascular ultrasound images provided by Endosonics products," according to the company. The two companies expect that the "technical evaluation and development" necessary to begin integrating the products will take approximately 18 months.
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