FDA panel recommends approvalof ATL's breast ultrasound PMA

Ultrasound competitors await ATL's next step

A Food and Drug Administration advisory panel unanimously recommendedon Dec. 11 that the agency approve a premarket approval (PMA)application filed by ATL for using its HDI technology to helpphysicians differentiate malignant from benign solid breast lesions.ATL's actions are being watched with interest by other ultrasoundvendors, several of whom believe that a PMA should not be requiredfor ultrasound of solid breast lesions.

ATL hopes the technique will become an alternative to surgicalbiopsy for women with suspicious breast masses. The Bothell, WA,vendor filed the application in 1994, using research conductedin a two-year multicenter study of over 1000 women who were examinedwith its Ultramark 9 HDI scanner (SCAN 1/19/94).

The panel recommended that ATL's PMA be approved with the followingconditions: that the labeling be specific to detection of lesionsof 1 cm or larger, unless follow-up analysis finds statisticalsignificance in smaller lesions, and that the company providetraining for clinical users in the application. The main sectionof the proposed labeling is as follows, according to Dick Tabbutt,director of outcomes research at ATL.

"The HDI system is indicated to provide a high level ofconfidence in differentiating benign from malignant or suspiciouslesions that have been detected by mammography and/or physicalexamination for which the diagnosis is indeterminate," Tabbuttsaid. "Using the HDI system to evaluate solid mass characteristicscan reduce the number of biopsies performed."

ATL, the FDA and other vendors are careful to point out thatif the PMA is approved, it will not affect the practice of clinicians,over whom the FDA has no authority. However, it will give ATLthe ability to both market and educate physicians about the breastultrasound capabilities of HDI that are covered by the PMA, accordingto Dr. Susan Alpert, director of the FDA's Office of Device Evaluation.

"We're not regulating the clinicians. Clinicians willcontinue to manage their patients to the best of their ability,"Alpert said. "We regulate the company, their manufacturingand their claims."

If the PMA is approved, ATL will focus its initial effortson educating clinicians in the use of HDI technology for helpingdifferentiate malignant from benign lesions, Tabbutt said. Thevendor will make on-site visits and develop course materials forthe application -- actions that would not be possible withoutthe agency's imprimatur.

"We would not be able to develop any kind of clinicalmaterials or have education courses specifically in this areasponsored by ATL without the FDA's clearance," Tabbutt said."(If approved), this gives us the ability to begin to developthis use of high-definition ultrasound directly, and that's ourfirst goal."

ATL's marketing plans for the application are still under development,according to spokesperson Anne Bugge.

Vendors respond. Many of ATL's competitors are concerned aboutthe PMA for several reasons. If it is approved by the agency,it will give the vendor a powerful advantage in an applicationthat is experiencing rising interest and usage. The advisory committee'saction received widespread coverage in the consumer media, andanecdotal reports indicate that women with indeterminate mammogramsare asking their physicians to conduct the procedure before theygo to biopsy.

Acoustic Imaging of Phoenix has made breast ultrasound imaginga focus of its efforts. Steven Kaska, director of worldwide strategicmarketing for AI, believes that ATL's PMA recommendation couldbe a double-edged sword.

"We really welcome the attention that's being given tobreast imaging ultrasound," Kaska said. "However, wedon't feel we need to file for a PMA. Our technology has beenclinically documented to assist the assessment of malignant frombenign tumors. We have a concern about the implication that onlyone technology can be used (in this application)."

Several companies are also concerned that ATL's move sets anunwelcome precedent by increasing federal regulation of ultrasound,according to Samuel Maslak, chairman and CEO of Acuson of MountainView, CA.

"Because ultrasound has a perfect safety record, and becausethe 510(k) process already permits this type of application ofultrasound, we really should be moving in the direction of lessregulation, not more," Maslak said. "PMAs are very expensive,and these costs ultimately are paid for by the medical communityin any of several ways. It could be in higher equipment prices,it could be in delays in introducing new equipment."

Acuson filed a citizen's petition last summer with the FDAasking the agency to develop criteria for determining when a 510(k)is appropriate for ultrasound and when a PMA is required. Thepetition also asks the agency to expand ultrasound's current 510(k)small-parts breast indications to include morphological differentiationof solid breast lesions. The vendor had not heard back from theFDA at the time of the advisory committee meeting, Maslak said.

If ultrasound vendors find they must duplicate ATL's move forcompetitive reasons, will they have to file a PMA or will theybe able to piggyback on ATL's PMA with a less rigorous filing?The FDA's Alpert says the law requires them to go with an originalPMA. Once four PMAs have been approved on an application, however,the FDA can reduce the amount of data required by subsequent PMAs,Alpert said.

Acuson said it is not planning to file for a PMA similar tothat of ATL, but might be forced to do so if ATL promotes breastimaging applications heavily.

"If the consequence of heavy promotion is such that wealso need to engage in that kind of promotion, then we would reconsiderfiling for PMAs, but that would be an unfortunate outcome foreverybody," Maslak said.

For its part, ATL plans to try to expand the PMA if it is approved.The company intends to file a supplemental PMA to allow it topromote the applications on its new HDI 3000 platform. It alsowill work with the FDA to have the PMA extended to lesions largerthan 0.5 cm, Tabbutt said.