Intravascular firms dance a do-si-do

Shifting alliances in intravascular ultrasound compose a dancechoreographed by companies with an eye on a market that just mightbe something--someday. Catheter firm Boston Scientific partedwith ultrasound vendor Diasonics in July to jump on the back ofHewlett-Packard's large echocardiography installed base.

Diasonics will continue to market its IVUS intravascular ultrasoundsystem in areas outside of cardiology. Within cardiology, thevendor will now focus on technology supplied by CardiovascularImaging Systems (CVIS). CVIS intravascular catheters have beenmated to a cardiovascular ultrasound system manufactured by VingmedSound, the Norwegian subsidiary of Sonotron. Sonotron is Diasonics'European subsidiary.

CVIS may not gain access to a cardiology base the size of HP's,but the firm expects Sonotron's marketing strength to boost salesof its catheters in Europe. Vingmed also has a U.S. office nearOEC Diasonics in Salt Lake City, although its U.S. market positionis not as strong as in Europe.

The agreement puts CVIS back on track in its effort to buildsales by offering its Insight intravascular ultrasound catheterfor use on general-purpose scanners. An earlier such supply arrangementwith Siemens broke down at the end of last year (SCAN 6/17/92).

While the Vingmed relationship expands opportunities for CVISin Europe, the Sunnyvale, CA, firm boosted its technical baseand clinical connections last month with the acquisition of intravascularcompetitor Intertherapy of Santa Ana, CA, said Richard M. Ferrari,CVIS president. CVIS and Intertherapy had been in court over countervailingpatent infringement claims.

Both HP/Boston Scientific and Vingmed/CVIS showed their intravascularultrasound products at the European Congress of Cardiology meetingin Barcelona last month. The fact that these intravascular systemsdebuted in Europe does not signal any greater market opportunitythere than in the U.S., however.

REIMBURSEMENT, OR THE LACK THEREOF, is as big a problem in Europeas it is in the American market, Ferrari acknowledged. The Vingmedintravascular offering is a general-purpose device, with CVIScatheters running on the Vingmed 800 color-flow Doppler scanner.It will sit nicely with cost-sensitive European users, he predicted.

"This product will sell well in the European market wheredollars are tighter and the role of interventionalists and echocardiographersis not as distinct as here in the U.S.," Ferrari told SCAN.

Lack of reimbursement for imaging-only intravascular catheters,while important, is not the prime factor holding back widespreaduse of this ultrasound technology, countered Robert M. Arcangeli,corporate manager of ultrasound marketing for Boston Scientific.

"It is more of a clinical issue. If we prove clinicalutility, reimbursement will follow," he said. "We haveseen many cases where the quality of the (intravascular) imagehas made a difference in clinical treatment of a patient. It justhas to be proven. The cases have to be taken together and putinto a convincing argument."

The HP/Boston Scientific product, labeled HP Sonos, is an independentintravascular system running on HP's Sonos 100 mechanical scannerplatform revamped for use with Boston Scientific catheters, saidKevin M. King, program manager for Hewlett-Packard Medical Productsin Andover, MA. The unit will list for $95,500 in the U.S. Shipmentsare expected to begin this month.

HP's joint sales and marketing relationship with Boston Scientificin intravascular ultrasound is exclusive for cardiovascular applications,including peripheral vascular work, King said.

Sales of the Diasonics/Boston Scientific intravascular systemwere split about evenly between U.S. and international markets,Arcangeli said. He was not sure if that would be the case withHP.

"We are very proud of what we did with Diasonics,"he told SCAN. "During the years we were associated with them,we placed over 100 units and were doing well competitively."

Boston Scientific will continue to provide catheters to Diasonicssystems that require them, but will not actively sell productswith the vendor, Arcangeli said.

The CVIS contract with Vingmed/Diasonics will allow that intravascularfirm to develop an upgrade package for the current installed baseof IVUS systems, Ferrari said.

"We will be exploring that opportunity to provide ourcatheters on the Diasonics system," he said.

IVUS users would have to chose one or the other catheter option.The system would not be able to operate with both, he said.

Boston Scientific searched for a new ultrasound scanner platformlargely for performance reasons, Arcangeli said.

"Over the last year, we were unable to take that nextstep to higher frequencies with Diasonics on a timely basis. HPwill definitely bring us more in terms of technology," hesaid.

HIGH-FREQUENCY IMAGING IS A REQUIREMENT for viewing optimal detailin small arteries, Arcangeli said. As in standard ultrasound imaging,higher frequencies provide greater detail and resolution but lesspenetration.

"When you are looking at very small arteries like the coronaryarteries, you want to be operating at as high frequencies as possible--30MHz or even higher," he said.

When the frequency exceeds a certain level, however, the intravascularultrasound device will start picking up blood cells in the field-of-view,he said. Lower frequencies of 8 to 12 MHz are preferable for imaginglarger vessels.

The HP Sonos intravascular system operates on three frequencies:12.5, 20 and 30 MHz. Diasonics' IVUS operated only at 12.5 and20 MHz, Arcangeli said.

High-frequency limitations are not a problem with the Vingmed/CVISsystem, however, Ferrari noted.

"We pioneered higher frequencies (in intravascular ultrasound),"he said. "We were the only company to offer 30 MHz beforeHP came on the market with it."

The CVIS imaging system was easily adapted to Vingmed's scannersince CVIS had built its intravascular product using hardwareoriginally licensed from Vingmed, Ferrari said.

"There is a lot of history between CVIS and Vingmed. Thatis why the adaption of our motor drive and imaging catheters tothe Vingmed platform is fairly straightforward," he said.

Diasonics looks to the Vingmed/CVIS system to help it gainbetter share in cardiology applications of intraluminal ultrasound.The ultrasound vendor will continue to promote IVUS for peripheralvascular and endoscopic (nonvascular) applications, said RoderickYoung. Young is president of Diasonics' new division being setup to develop and commercialize an ultrasound tissue ablationproduct.

Diasonics introduced an endoscopic catheter for IVUS at theRadiological Society of North America meeting last year. The catheteris manufactured by Boston Scientific.

"The whole (intravascular ultrasound) business is stillpretty slow," Young said. "IVUS was targeted at peripheralvascular, not cardiology (applications). As we progressed, wedid some cardiology work, but it proved not to be an ideal cardiologyproduct. Vingmed will have a better system in that area."

HP's current ultrasound installed base involves the same groupof doctors who use intravascular systems, which should help HPand Boston Scientific start up their joint effort, HP's King noted.

"Strategically, we have always targeted cardiovascularapplications at HP. Cardiovascular applications (of ultrasound)are performed by interventional cardiologists, interventionalradiologists, and to some degree, vascular surgeons. Those are all markets we address," he said.

But the intravascular ultrasound market is small compared toHP's current echocardiography business, he said. That is one reasonit makes sense to use technology developed by a catheter specialist.

"Interventional products are their (Boston Scientific's)business. Ours is selling imaging systems. It is a good matchof skills," King said.

INADEQUACIES INHERENT IN ANGIOGRAPHY are a prime reason why themarket for intravascular ultrasound should pick up eventually,King said. Angiography provides only a projection image of vessels,he said.

"Angiography is not providing information about the wallwhere the disease process occurs and is very insensitive in thepostprocedure stage," King said. "Cardiologists maybe slow to change because they have a tool they have used formany years. Angiography is a good tool, but it has some shortcomings.Ultrasound looks like it can fill some of those holes."

Intravascular ultrasound provides the ability to image vesselsprior to, during and following therapy. Endoscopy can also dothis but does not work in the coronary arteries, he said.

Clinical demand for intravascular ultrasound may also growas an alternative technique to transesophageal imaging, Ferrarisaid.

"It is another way to image the valve and cardiac performance.We (at CVIS) believe it may be better than transesophageal, especiallyin certain patient groups," he said. "Placing a catheterinto the heart is the only way you can evaluate (cardiac) performancefor critical care patients who cannot swallow the TEE probe. Itwill be a nice market over time."

CVIS' ACQUISITION OF INTERTHERAPY kills many birds with one stoneand provides the firm access to a number of luminary sites inintravascular ultrasound, Ferrari said.

A definitive agreement for the acquisition was signed lastmonth with Intertherapy following a letter of intent in August,he said. The purchase is indication that CVIS had a strong patentposition in its legal battle with this competitor.

CVIS has purchased all the assets of Intertherapy, includingpatents and other technology. The firm will explore applicationof this technology to new products, he said.

"The sheaf design in their catheter was a nice feature.Some aspects of the system, such as their PC platform, were alsoattractive to us," Ferrari said.

Perhaps most important, however, CVIS has picked up what amountedto 15% of the installed base in intravascular ultrasound at theend of last year, he said. The firm also absorbed a potentiallystrong future competitor, he said.

"They had some very influential users. Certainly, we areselling catheters to those users. Those customers will becomeCVIS customers. This gives us greater strength overall in themarketplace," Ferrari said.

One stellar user CVIS gained access to from Intertherapy isDr. Martin B. Leon, a noted interventional cardiologist and directorof the experimental angioplasty program at Washington HospitalCenter in Washington, DC.