A Medical Device Daily
Boston Scientific 's (Natick, Massachusetts) TAXUS PETAL I trial, marking the first human use of the company's Taxus Petal Bifurcation paclitaxel-eluting stent system, has begun with implantation of the new system in a patient in New Zealand. The procedure was performed by John Ormiston, MD, at Auckland City Hospital .
The trial is designed to evaluate the safety of a dedicated bifurcation paclitaxel-eluting stent platform for the treatment of coronary artery disease (CAD). Boston Sci said that a significant percentage of coronary artery disease — as much as 30% — occurs at a bifurcation, where one artery branches into two smaller arteries. "Bifurcations present a common location for the build-up of plaque and are particularly difficult to treat with currently available stents," the company said.
The Taxus Petal Stent is designed to treat both the main branch and the side branch of a y-shaped bifurcation.
"The Taxus Petal Stent enabled us to successfully treat a patient with a difficult bifurcation stenosis," said Ormiston, the principal investigator for the TAXUS PETAL I trial. "Bifurcations are a major challenge in interventional cardiology, and the development of a dedicated drug-eluting bifurcation stent is an important advancement."
He said the design of the stent provides "consistent mechanical support and drug application not only to the main branch but also to the side-branch ostium, where re-narrowing is common with other techniques used today."
The trial is a non-randomized study with an initial assessment of acute performance and safety (death, myocardial infarction, target vessel revascularization) at 30 days and six months, as well as continued annual follow-up for five years.
TAXUS PETAL I will enroll a total of 45 patients in New Zealand, France and Germany. Boston Scientific said that upon successful completion of the study, it intends to begin a pivotal trial to gain U.S. and international approval for the stent.
The Taxus Petal Stent consists of a traditional drug-eluting stent with a side structure — the Petal Strut — in the middle of the stent that opens into the side branch. The new stent is coated with the proven combination of the paclitaxel drug and Translute polymer.
Angiotech Pharmaceuticals (Vancouver, British Columbia) provides the paclitaxel drug for Boston Sci's stents.
Hill-Rom, Japanese firm in distribution accord
Hillenbrand Industries said that its medical technology subsidiary, Hill-Rom (both Batesville, Indiana), has entered into a distribution agreement with Paramount Bed Co. (Tokyo), allowing Paramount Bed to distribute certain Hill-Rom hospital bed systems in Japan.
Hill-Rom described Paramount Bed as "Japan's leading innovator and maker of medical beds and patient support prevention and therapy systems."
In addition to the distribution of Hill-Rom's products in Japan, the company said the new agreement will open the door for global product collaboration between the two companies.
Kenji Kimura, president and representative director of Paramount Bed, said, "As we see globalization in every aspect of our lives, this agreement is making full use of both companies' specialties to strengthen business activity, which we believe will broaden the alliance. I look to the end results with high expectations."
Peter Soderberg, president and CEO of Hillenbrand Industries and Hill-Rom, added, "This alliance both strengthens and accelerates our presence in the international arena and does so with an international leader and company with strong family roots we have long admired. Mr. Kimura and I, and our organizations, believe we have an opportunity to provide further innovation worldwide and across the continuum of care by working more closely together."
It is anticipated that Hill-Rom's products will be available in Japan through Paramount Bed beginning in early September.
Menicon eyes global growth
Menicon 's (Nagoya, Japan) recent acquisition of Flat Pack technology, including all intellectual properties and other related assets, from 1800CONTACTS (Draper, Utah) and its Singapore-based subsidiary, ClearLab International (Medical Device Daily; July 12, 2007), "will play a vital role in truly globalizing the company," said Dr. Hidenari Tanaka, Menicon's president.
Menicon will manufacture the Flat Pack daily disposable lens, Menicon 1day, in Singapore to export to global markets, including Japan.
In December 2004, Menicon entered into a license agreement with 1800CONTACTS, which allowed Menicon to become the exclusive licensee of the technology in Japan, the second-largest contact lens market in the world after the U.S.
With last month's acquisition, Menicon has become the sole owner of the Flat Pack technology on a global basis, which will allow the company to commercialize the technology as flat-pack disposable contact lenses and to license the technology to other manufacturers.
Menicon, which was founded in 1951, was Japan's first and is its largest contact lens manufacturer, and is represented in more than 30 countries.
Scantek, Bin Herz in distribution pact
Scantek Medical (Ledgewood, New Jersey) said it has entered into a distribution agreement with Bin Herz General Trading (Dubai, United Arab Emirates), under which Bin Herz has been granted exclusive distribution rights for Scantek's BreastCare/BreastAlert Differential Temperature Sensor product.
The agreement covers sales in Afghanistan, Algeria, Bahrain, Egypt, Iraq, Jordan, Kuwait, Lebanon, Libya, Malaysia, Morocco, Oman, Pakistan, Qatar, Saudi Arabia, Tunisia, United Arab Emirates and Yemen.
The agreement has a term of five years. Bin Herz has the right to extend the agreement for up to two additional three-year periods.
Scantek also reported that it moved its operations from Cedar Knolls, New Jersey, to a new facility in Ledgewood having about 22,300 square feet. The new facility includes office, manufacturing and warehouse space.
BreastCare is a non-invasive, single-use medical device that detects tissue heat differentials between the breasts. Scantek also is developing medical devices that use its temperature differential technology to screen for other medical conditions, including prostate problems and susceptibility to stroke.
The company has subsidiaries in Hungary and Brazil.