Volcano expects to add Novelis' forward-looking intravascular ultrasound (FLIVUS) to the tools available with its s5i intravascular imaging system by the end of 2009.

The San Diego company announced May 19 that it acquired privately-held Novelis for $12 million in cash plus the promise of a $3 million milestone payment after achievement of an unspecified regulatory goal.

Volcano expects to complete a late-stage prototype of Novelis' PreView FLIVUS catheter and begin first-in-man trials in the Netherlands by the end of 2008. Volcano expects PreView to earn a European CE mark and FDA approval by the end of 2009.

PreView can be used with existing occlusion-crossing guidewires. Volcano expects to sell PreView for $1,000 per single-use catheter; with about 300,000 procedures to treat chronic total occlusions performed annually worldwide, the potential market is $250 million, Volcano says.

Methuen, Mass.-based Novelis has also been developing the Mackinaw FLIVUS catheter with a radiofrequency (RF) ablation tip, which can be steered through an occlusion as the RF creates an open space for the catheter to advance.

Volcano expects to begin first-in-man studies of Mackinaw in mid-2009 and earn U.S. and European regulatory approval for the device in the second half of 2010. The company estimates about 500,000 procedures performed annually are amenable to the FLIVUS-plus-RF approach. At $2,000 per catheter, Mackinaw represents a $1 billion opportunity.

The addition of FLIVUS is a continuation of Volcano's strategy of offering a variety of vascular diagnostic catheter-based tools that can be used with the common s5i computer platform. The s5i system is currently compatible with Volcano's solid-state and rotational IVUS catheters as well as its line of pressure-gradient sensor guidewires.

The firm also expects to add optical coherence tomography (OCT) systems and catheters to the tools available with s5i in the second half of 2009. In December, Volcano announced the acquisition of OCT developer CardioSpectra for $63 million (¹ Also see "Volcano Adds CardioSpectra High-Res Imaging To Intravascular Portfolio" - Medtech Insight, 17 December, 2007., p. 14).

On May 8, the firm announced that the first human procedure with the Volcano OCT catheter had been conducted in Rotterdam.

Novelis Finds Solution To IVUS' Blind Spot

Recognizing the potential value of FLIVUS to a broad range of cath-lab applications, Volcano had been talking to Novelis about a potential partnership for several years, Vincent Burgess, Volcano executive VP for marketing and business development, told "The Gray Sheet."

Interventionalists have long wanted to be able to visualize the area inside of the vessel in front of the IVUS catheter. Forward-looking visualization presented a significant technical challenge because it is very difficult to create an IVUS transducer that will fit on the tiny surface area on the tip of a catheter, Burgess explained.

Current IVUS technology creates an image of the inside of a vessel by emitting and receiving sound waves from the side of a catheter, so it is unhelpful when crossing a wire or catheter through a total occlusion of the vessel. Interventionalists' only method for crossing the occlusion is to push a guidewire through the occlusion "blind," taking several hours and risking perforation of the vessel. Because of this risk, interventionalists often refer patients with total occlusions for invasive bypass surgery.

Novelis' solution to this problem was to design an IVUS catheter tip with an ultrasonic transducer slightly offset from the tip at the front end of the catheter. This creates an ultrasound image of a 30-degree "cone" in front of the catheter tip, showing the operator where the tip of the catheter is going as it is pushed through the vessel, even inside a total occlusion.

In addition to the coronary occlusion indications addressed by PreView and Mackinaw, Novelis has completed prototypes of FLIVUS devices for crossing occlusions and modifying plaque in peripheral vessels.

According to Volcano, FLIVUS may someday be adapted for indications beyond vascular intervention, including repair of structural heart defects, atrial fibrillation ablation, valve repair, breast biopsy, nerve ablation and placement of pedicle screws in small vertebrae.

- Reed Miller (re.miller@elsevier.com)

Volcano Adds ‘Forward-Looking’ IVUS To Interventional Imaging Suite

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