CathRx pleased by positive catheter trial results

A clinical trial conducted by Sydney medical device company CathRx (ASX:CXD) has shown that its catheters can appropriately diagnose arrythmias when measuring electrical signals generated by the heart.

"100 per cent of the catheters used were able to perform the diagnosis required," said CathRx's chairman Denis Hanley.

The trial studied 15 patients, with 12 patients trialled with CathRx modular diagnostic catheters and three patients using other devices for comparison.

"The clinical procedure for diagnosing these arrhythmias is an established procedure," said Hanley. "We're basically trying to show equivalence to products that are on the market and therefore get marketing registration."

All of the CathRx catheters in the trial showed good quality signals and none needed to be replaced to complete diagnosis. Also, overall handling characteristics were acceptable when compared with the clinician's expectations.

"The secondary data is about what features the doctors liked about [the catheter], from a handling point of view," said Hanley. "There was a reasonable spread but a bias towards the positive."

The data from this stage of the trial will be included in CathRx's submissions for registration of its modular catheter by the Therapeutic Goods Administration (TGA) in Australia and CE Mark approval in the European Union, which will be lodged in the next couple of weeks, said Hanley.

"We'd be expecting the CE Mark mid year," said Hanley, and TGA approval at around the same time.

CathRx is continuing with the second stage of its trial which will involve 30 test patients and 30 comparison patients. "We're going to get a broader spread of doctors, so the numbers will continue to grow, the trial really goes on," said Hanley. "For the next couple of months we'll continue to collect data from various doctors. Really we're trying to understand the breadth of doctors' likes and dislikes."

CathRx's catheters

The catheters used in the trial are CathRx's first product range and are used in the right side of the heart. CathRx has developed a novel electroless deposition process for plating electrodes onto catheters, said Hanley. The company's manufacturing method enables the company to build more electrodes, and electrodes of different sizes, into the catheters' sensing array than is currently possible with other technologies.

CathRx has also built multiple steering choices into each catheter and the company markets the steering apparatus separately to the electrode sheath. "The steering apparatus is not in contact with the patient's blood so it can go through the hospital's steam sterilisation process," said Hanley.

Over time, the company plans to address the more difficult clinical procedures of the left side of the heart such as atrial fibrillation.

"We'd be looking to have some of the second range of products go into initial clinical work this year," said Hanley. "We've got the prototypes and we're doing all of the testing you have to do in terms of the physical attributes of the product."

UK distributor

Meanwhile, CathRx has appointed CardioCare as the exclusive distributors for its modular catheters in the United Kingdom. UK-based CardioCare has been a provider of cardiovascular devices for over 14 years, and was responsible for distributing Ventritex and EP Technogies (Boston Scientific) devices, according to CathRx.

"These distributors are not exactly distributors in the normal sense of a large company, they tend to be closer to commission sales people," said Hanley. "They work in this particular field and they know the clinicians and have a good reputation and basically work with companies such as us that have cutting edge technology but not a major marketing organisation."

Hanley said that CardioCare will also probably be involved in early-stage clinical trialling of CathRx's products while the company files for CE Mark approval.

CathRx is also in negotiations with a "couple of other" distributors, said Hanley. "Obviously with a product like this, you aspire to have a world reputation, not just an Australian reputation," he said.

With an Australian market of only 20 or so locations, CathRx will have its own direct sales force for its catheters in Australia, said Hanley.