A Medical Device Daily

Boston Scientific (Natick, Massachusetts) reported the international launch and initial implantation of the Promus everolimus-eluting stent, making it the only company to offer two distinct drug-eluting stent (DES) platforms.

Dr. Willibald Maier performed the procedure on Dec. 21 at University Hospital (Zurich, Switzerland).

Promus is a private-labeled Xience V coronary stent system manufactured by Abbott (Abbott Park, Illinois) and distributed by Boston Scientific. The stent was designed and is manufactured by Abbott and supplied to Boston Scientific as part of a distribution agreement between the two companies announced last year.

The Promus system received CE-mark approval last October, allowing Boston Sci to distribute the stent in select countries of the European Economic Area.

It also will be available in selected countries in Asia, Latin America and Eastern Europe, and a U.S. launch is anticipated for 2008.

Abbott launched the Xience V system in Europe in October, and it is currently available in most major European and Asia-Pacific markets.

“The addition of the Promus stent gives [us] the ability to offer clinicians two highly deliverable options — our market-leading Taxus paclitaxel-eluting stent and Promus, our high-potential everolimus-eluting stent,” said Paul LaViolette, chief operating officer of Boston Sci. “The Promus tent complements our broad DES portfolio and further reinforces [our] leadership in the DES market.”

John Capek, PhD, president of Abbott Vascular (Redwood City, California), said the product roll-out “allows more patients to have access to the advanced, next-generation drug-eluting stent technology that underlies the Xience V system.”

The Xience V system is based on the Multi-Link Vision stent, sold to Abbott as part of the mammoth deal last year (Medical Device Daily, April 24, 2006) in which Boston Scientific acquired Guidant (Indianapolis).

Positive results for the Xience V stent were reported from the SPIRIT II clinical trial at the World Congress of Cardiology in Barcelona, demonstrating that the stent met its primary endpoint of non-inferiority to the Boston Scientific’s Taxus stent as measured by late loss at six months.

Abbott said it would present results from the randomized portion of the SPIRIT III pivotal trial in the first half of this year. SPIRIT III is a large-scale pivotal trial comparing the Xience V stent system to the Taxus system.

Some 3 million Taxus stents have been implanted in patients worldwide and clinical follow-up has been conducted on more than 4,000 patients out to four years.

Portugal added to Misonix markets

Misonix (Farmingdale, New York), which develops ultrasonic medical device technology for the treatment of cancer and other chronic health conditions, has expanded its European business of visually directed, high-intensity focused ultrasound (HIFU) using the Sonablate 500 with entry into Portugal.

The company reported signing an agreement with Sociedade Avan o (Lisbon, Portugal), a medical device distributor in business for more than 40 years.

The Sonablate 500 (SB 500) was developed by Focus Surgery (Indianapolis) and is manufactured by Misonix, which also has the exclusive European distribution rights for the product.

Misonix is an investor in privately held Focus Surgery, which it said is a global leader in HIFU development.

Europe’s Comprehensive Cancer Monitoring Program says there are more than 200,000 new cases of prostate cancer on the continent annually, the approximate equivalent of that in the U.S., although there presently is no HIFU treatment approved for use in the U.S.

HIFU treatment using the SB500 is an approved procedure in most European countries. Prior to the entry into Portugal, the procedure has been available in 10 European countries, and to date more than 4,000 SB500 treatments have been completed worldwide, Misonix said.

UK questions Biopure on Hemopure

Biopure (Cambridge, Massachusetts) said that, as expected, it has received a provisional opinion letter from the UK Commission on Human Medicines containing comments and questions based on its review of the company’s marketing authorization application (MAA) for its oxygen therapeutic, Hemopure [hemoglobin glutamer - 250 (bovine)], for the treatment of acutely anemic adult orthopedic surgery patients under 80 years of age.

Hemopure is an intravenously administered pharmaceutical consisting of stabilized bovine hemoglobin formulated in a balanced salt solution. These chemically cross-linked hemoglobin molecules circulate in the plasma when infused and are smaller, less viscous and more readily release oxygen to tissues than do red blood cells.

The company said the letter provides it the opportunity to respond to the issues before the commission gives its final advice to the Medicines and Healthcare products Regulatory Agency (MHRA), the licensing authority in the UK.

The letter identifies as “major” certain issues relating to toxicology, quality, clinical efficacy and safety, including Hemopure’s benefit-risk balance in the proposed indication when blood is readily available. It captions as “other” several dozen issues primarily relating to chemistry, manufacturing and controls.

Biopure noted that unless these issues are satisfactorily addressed, the commission may be unable to recommend marketing authorization.

“Based on our initial review of the letter, we believe the issues are addressable,” said Zafiris Zafirelis, CEO and chairman of Biopure. “During the next several weeks, we expect to continue evaluating the issues and the time and resources required to fully respond to the commission’s questions.”

Biopure submitted its application to the MHRA last July, and the agency accepted it for review in September. The issuance of a provisional opinion letter with questions from the Commission on Human Medicines, an advisory body to the MHRA, is a standard, interim step in the review process. The company has up to six months to respond to the commission’s questions, and can request an extension.

Hemopure is compatible with all blood types and stable for three years without refrigeration. Other than red blood cell transfusion, Biopure said there is no approved therapeutic for human use in Europe or the U.S. that can transport oxygen to tissues.