Tools clear up ultrasound in intervention guidance

Pressure to cut health-care costs has led physicians to use ultrasoundin place of more expensive modalities such as CT and MRI. Butwhile ultrasound has proved a worthy alternative for many diagnosticapplications, its utility in guiding therapy has been limitedby visualization problems.

Clearing up ultrasound visualization is the goal of EchoCath,a Princeton, NJ-based company with a pipeline of novel ultrasoundperipheral products.

EchoCath's products are intended to serve as "electroniccontrast agents" that can solve visualization problems andincrease the number of interventional procedures that can be performed,according to EchoCath president Frank DeBernardis.

"The goal of our business is to use ultrasound to do morediagnostic and therapeutic procedures," DeBernardis said."Ultrasound to date has been used exclusively for diagnosticwork. Because of frustrations in not being able to see devices,it hasn't been used to its fullest potential when it comes toguiding therapy."

EchoCath was founded in 1990. The firm is currently developingthree products designed to improve ultrasound visualization. Theseare:

• EchoMark, a piezoelectric crystal sensor mounted on a catheter that enables an ultrasound scanner to better plot the catheter's location;
• EchoEye, a forward-looking catheter-mounted intraluminal ultrasound transducer; and
• ColorMark, a device that improves needle visualization during ultrasound-guided needle biopsy.

ColorMark is closest to market of the three. EchoCath has filedfor Food and Drug Administration 510(k) clearance for the deviceand expects to begin marketing ColorMark in September. EchoCathdisplayed the product at the American Institute of Ultrasoundin Medicine meeting in Hawaii in March.

ColorMark consists of a driver box wired to a clip that attachesto a biopsy needle. The driver box creates a signal that causesa piezoelectric crystal in the clip to vibrate the needle at afrequency of 3 MHz. The needle moves a total distance of 30 micronswhen vibrating.

The needle creates a phase shift that is detected by the color-flowimaging section of a color Doppler scanner. The needle shows upas a multihued stripe of color on the scanner screen.

"Because the needle is going back and forth, instead ofin a unidirectional way, you get mixed colors on the screen, whichmakes it easy to distinguish the needle from things like bloodvessels," said David Vilkomerson, senior executive officer.

The company estimates that each year 1 million to 1.5 millionneedle biopsies are performed in which needle visualization iscritical enough to warrant the use of some type of aid.

The ColorMark clip, which is disposable, can be used with aconventional needle of any size normally used for biopsy. Thedriver box will sell for about $5000 while the clips will cost$50 each, according to the company.

EchoCath intends to market ColorMark directly but will alsoconsider OEM contracts with hardware suppliers, according to thecompany.