ISG wins FDA clearance for 3-D Viewing Wand

Firm explores real-time imaging applications

Add ISG Technologies to the list of companies celebrating theFood and Drug Administration's spring cleaning of its productreview backlog. The Mississauga, Ontario-based company last monthreceived 510(k) clearance for Viewing Wand, a three-dimensionalintraoperative image guidance system submitted for approval threeyears ago.

Viewing Wand is a mix of hardware and software designed tohelp guide surgeons by correlating a patient's preoperative MRIand CT scans with anatomy encountered during surgery (SCAN 11/7/90).

The system consists of a workstation linked to a position-sensingarticulated arm tipped with a hand-held probe. As the probe ispositioned in and around the patient's skull, it appears on theworkstation as a "virtual probe" that can help neurosurgeonsand ear, nose and throat (ENT) surgeons localize pathology andnavigate around critical structures.

Viewing Wand allows smaller craniotomies to be performed andcan speed surgery by helping clinicians identify vital anatomy,according to the company. ISG also claims that Viewing Wand canreduce the risk of injury to patients by helping surgeons avoidnormal structures.

Viewing Wand has been used in more than 1500 cases at installationsaround the world, and clinicians have reported shorter surgeries,fewer complications and reduced hospitals stays, according tothe company.

ISG plans to coordinate Viewing Wand's intraoperative applicationswith real-time imaging, according to Tom Ekers, vice presidentof product groups and marketing.

"We have a strong desire to bring image-guided surgeryinto real-time imaging environments," Ekers said.

The list price of Viewing Wand is $200,000 (U.S.). ViewingWand can be operated independently or in conjunction with ISG'sAllegro Silhouette second-console workstation.

Viewing Wand is being marketed worldwide except in Japan byElekta of Sweden for neurosurgical applications. Elekta manufacturersthe Gamma Knife radiosurgery system.

Mitsui of Japan handles the product for all applications inJapan, with ISG distributing Viewing Wand worldwide for all ENTapplications outside Japan.

In other ISG news, the company released its financial resultsfor the third quarter of 1994 (end-March). ISG reported revenueof $5.3 million for the quarter, compared to $4.4 million in thesame period a year ago. The company reported a loss for the quarterof $253,000, compared to $326,000 in the third quarter of 1993.

The company expects revenue to increase in the fourth quarterdue to Viewing Wand sales and increased sales of its IAP (ImagingApplications Platform) product.