A Medical Device Daily
W. L. Gore & Associates (Flagstaff, Arizona) reported receipt of regulatory clearance from Japan's Pharmaceuticals and Medical Device Agency (PMDA) to market the Gore TAG Thoracic Endoprosthesis in that country.
The Gore TAG device is used to treat aneurysms of the descending thoracic aorta, the largest artery in the body. The Gore TAG device was designated as the highest priority device for expedited PMDA review by the various physician societies in Japan. The device, which was the first approved thoracic stent-graft in the U.S., received its approval from FDA in March 2005.
Patients with a thoracic aortic aneurysm are at risk of death due to internal bleeding resulting from a rupture of their aorta. Traditional treatment of these aneurysms requires open surgery and a large surgical incision to repair the diseased artery with a synthetic graft.
The Gore TAG Device, a flexible ePTFE graft with an outer self-expanding nitinol support structure, internally relines the aorta and isolates the diseased segment from blood circulation. The device is inserted by employing a minimally invasive catheter delivery technique through a small incision in the patient's groin.
The first post-PMDA approval procedure using the Gore TAG Endoprosthesis was conducted by Toru Kuratani, MD, at Osaka University, and was supported by Takao Ohki, MD, who has a significant amount of experience with the device.
"The Gore TAG endoprosthesis offers tremendous potential for patients affected with an aortic aneurysm because it prevents an aneurysm from rupturing and reduces the morbidity and mortality associated with open surgery," said John Sininger, who heads up the Gore Medical Products Division.
Hong Kong sales begin for Arctic Front
CryoCath Technologies (Montreal), a global leader in cryotherapy products to treat cardiac arrhythmias, reported the introduction of the company's Arctic Front device in Hong Kong.
Arctic Front, CryoCath's lead product for the treatment of paroxysmal atrial fibrillation (PAF), is a cryoablation balloon catheter that allows physicians to safely and effectively isolate all four pulmonary veins in the treatment of PAF.
Dr. Ngai-Yin Chan, head of the electrophysiological department at Princess Margaret Hospital (Hong Kong), performed the first procedures on May 28. Chan had previously attended the Arctic Front Masters Program for the cryoballoon system in Bad Neustadt, Germany.
"In Arctic Front, we see the potential for a groundbreaking therapy in the treatment of paroxysmal atrial fibrillation. Our belief in cryoablation with the experience we have has been reinforced by a growing body of clinical evidence in Europe and throughout the world," said Chan. "We are eager to offer Arctic Front as a ... safe and effective treatment to the thousands of patients in Hong Kong suffering from atrial fibrillation."
Jan Keltjens, president/CEO of CryoCath, said, "We are ... proud to see Arctic Front expand into new markets beyond Europe, first in Australia, and now in Hong Kong. With our rapidly growing body of clinical evidence, we are confident that our Arctic Front system will continue to broaden its user base. By strengthening our footprint in Asia, we look forward to delivering the benefits of our breakthrough therapy to a wider patient base, which will in turn accelerate the adoption of the Arctic Front system worldwide."
NeuroLogica's CereTom okayed in S. Korea
NeuroLogica (Danvers, Massachusetts) and its distribution partner, Dong Kang Medical Systems (Seoul, South Korea), said the CereTom scanner has received clearance from the Korean Food and Drug Administration (KFDA) for medical capital device imaging.
The CereTom is a portable, eight-slice CT scanner that acquires 1.25 mm slices per rotation. It is capable of performing NeCT, CT perfusion, Xenon perfusion and CT angiography. The company said it is optimal for use in the emergency room, intensive care unit and operating room because of its portability and ease of use.
"We are [pleased] that the CereTom has cleared Korean FDA," said President/CEO Eric Bailey. "South Korea is one of the most innovative and medically advanced countries in Asia, [and] we are confident that the CereTom will improve the standard of care for critically ill patients with neurological emergencies. Our distribution partner, Dong Kang, has an excellent reputation at the best medical institutions in South Korea; we are pleased that they will be representing the CereTom."
Chinese j-v nears for Denver-based firm
Medical International Technology (MIT; Denver) said that after "many months" of negotiations, it has reached a joint-venture agreement with one of the largest Chinese medical corporations.
An initial $1 million joint investment will permit the formation of an assembly line for MIT's Med-Jet and Agro-Jet product lines, according to President Karim Menassa.
Thereafter, another $10 million will be invested within the next three to five years for full manufacturing to satisfy the Chinese market.
Menassa said the j-v will help the company mass-produce all of its jet-injector models for human and animal applications. The initial target will be the Chinese market, which MIT said would lead to opportunities in many other countries.
Manufacturing OK for China Sky One products
China Sky One Medical (Harbin, China) said five of its products have received production permit approvals from that country's State Food and Drug Administration.
The products include an anti-smoking patch, a scar patch aimed at speeding the healing of trauma/surgical wounds, a migraine patch, an eye patch intended to hel relax the muscles of the retina, and a coronary disease patch that the company said increases circulation in coronary arteries.
Latin American expansion for Pall
Pall (East Hills, New Jersey), a company specializing in filtration, separation and purification systems and technologies, reported a five-year geographical expansion initiative in Latin America, which will encompass Pall's life sciences and industrial businesses in Central and South America, Mexico, and the Caribbean.