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Health: US FDA Gives Nod to Singapore-made Device for Peripheral Arterial Disease

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by Jared Heng

Dr Eitan Konstantino, President and CEO of TriReme Medical

A new medical device, the first of its kind produced in Singapore to be recently approved by the US Food and Drug Administration (FDA), seeks to treat peripheral arterial disease (PAD) with much greater efficacy than conventional solutions.

Called the Chocolate PTA Balloon Catheter, the device was developed by Quattro Vascular in collaboration with its US-based parent company TriReme Medical.

PAD afflicts some 40 million patients worldwide, many of whom are in Asia, Dr Eitan Konstantino, TriReme Medical’s president and CEO, said in an interview with Biz Daily.

The disease is one in which plaque builds up and restricts blood flow in the arteries in peripheral parts of the body, excluding the heart or brain.

Dr Konstantino noted that the global market for the treatment of blocked leg arteries is worth some US$2 billion. In Singapore alone, as many as up to 4,000 patients are estimated to suffer from the disease.

“PAD sufferers include some who are smokers, overweight, or have other conditions that result in pain while walking. As the disease progresses, they may even experience pain while resting and develop ulcers next to the ankles and legs that cannot be healed,” Dr Konstantino said.

He added that if left untreated, this would lead to gangrene and amputations, which are not uncommon and mainly the result of poor blood supply to the legs due to the blockages.

According to Dr Konstantino, opening blockages in the artery with a conventional balloon catheter carries a significant 40-per cent failure rate.

“When you inflate the conventional balloon in the artery, it tears the artery and disturbs the arterial flow, or when you try to open the artery, it does not open or only opens halfway,” he said, regarding the failed procedures.

He added that even if the procedure was successful, only about 20 per cent of the treated leg arteries would stay open after one year.

If conventional balloon catheters fail, stents may be used as a last resort. However, stents are also permanent implants with other kinds of potential complications.

“Stents work very well in the heart, but not very well in the legs. Ideally, you do not want to leave an implant in the legs because legs are always moving, which could deform the stent,” Dr Konstantino said.

Designed for one-time use, the Chocolate PTA Balloon Catheter forms small modules called pillows when the device is inserted in the leg. The device allows for inflation and deflation to open blockages in the leg, while lowering the strain and trauma induced on the vessel wall, according to TriReme Medical.

Dr Konstantino said Chocolate can achieve a “stent-like” result without using a stent, and seeks to reduce the failure rates.

Shortly before the FDA approval, a human trial study of Chocolate was done on 25 patients in Germany and New Zealand for one year. This achieved a zero-per cent failure rate and subsequent follow ups showed no complications, according to Dr Konstantino.

Currently available on the US and German markets, Chocolate is awaiting approval from the Health Sciences Authority of Singapore to be launched in the country.

Dr Konstantino said Chocolate will also be launched in China and Japan once the respective regulatory approvals in those countries have been obtained, adding that these nations, together with Singapore, are “very important” markets.

When asked why Singapore was made the manufacturing base for Chocolate, Dr Konstantino said it was an ideal location for a new medical device company amid rapidly growing Asian markets.

“The FDA approval proves that Singapore is an ideal location for producing high quality medical products. We have in Singapore all the right components to create what I would like to call the Silicon Valley of the East,” he added.

Regarding industry competition, Dr Konstantino said that while the cardiology and peripheral intervention markets are generally highly competitive, there are no other good solutions today for opening blockages in the lower extremities, mainly the legs.

“Here at Quattro, we are striving to bring this (Chocolate) technology to change the way peripheral interventions are being done to provide safer and more effective solutions for patients suffering from blockages in the legs,” he said.