A BB&T

In a move that Cook (Bloomington, Indiana) said further expands its global reach, the company’s Zenith Endograft, which it said is the world's top-selling device for endovascular repair of abdominal aortic aneurysms (AAA), has been approved for sale in Japan. The decision makes the Zenith endovascular graft system the first and only device available for endovascular repair of AAA in that country, one of the world’s largest medical markets.

“Cook’s success in being first to market in Japan with this life-saving medical device technology is the direct result of a collaborative effort involving [our] worldwide endovascular team and our Japanese distributor, Medico’s Hirata,” said Barry Thomas, global leader of Cook’s Endovascular Therapies division.

Cook’s Shonin filing was approved in mid-July. The Zenith endograft is approved as a new medical device and that status will be reexamined three years after the approval date. Cook also will provide detailed clinical training to Japanese physicians to ensure safe and effective use of the device. The approval was granted on the basis of the Zenith U.S. pivotal trial results, as well as on the basis of a limited confirmation trial that was performed in Japan.

The device has a nine-year history of successful use in Europe and a seven-year history in the U.S.

“As a physician who has treated numerous AAA patients, I welcome the introduction of Cook’s Zenith endograft technology in Japan,” said Kimihiko Kichi-kawa, professor of radiology at Nara Medical University. “Minimally invasive treatment of aortic aneurysms can greatly reduce patient suffering and recovery times compared to open surgical repair – important qualities considering that AAAs most commonly occur in older patients who may not be able to withstand the rigors of surgery.”

Professor Takao Ohki, MD, of Jikei University School of Medicine’s department of vascular surgery, said, “There are many patients in Japan waiting for an endograft to become available. The OR time for this procedure can be as little as 80 minutes when performed under local anesthesia. An aortic abdominal aneurysm treated with Cook’s Zenith endograft can have a patient discharged home on the second day.”

He added, “We are very excited to see this technology become available in Japan and look forward to successfully treating many patients in Japan, as has been the experience elsewhere in the world.”

Prior to the development of endovascular treatment, patients diagnosed with a large, swelling abdom-inal aortic aneurysm that could rupture faced extensive open surgery requiring days of recovery time in the hospital and weeks of post-procedural recovery time before they could resume normal activities.

During endovascular repair, the physician makes two small incisions in the groin to insert catheters that are guided under fluoroscopy to the site of the aneurysm. Once in place, the catheters deploy a self-expanding endograft constructed of polyester surgical graft material supported by stainless steel Z-stent bodies.

Genzyne eyes adding ankle, shoulder to label

Genzyme (Cambridge, Massachusetts) said it has filed with European authorities to expand the CE mark for Synvisc (hylan G-F 20) to include treatment of pain due to osteoarthritis (OA) of the ankle and shoulder. Approval of a new label will provide opportunity to broaden the use of Synvisc beyond its current European-approved use in the knee and hip to the two additional joints.

“Our filing in Europe for approval of Synvisc in the ankle and shoulder reaffirms our commitment to the field of osteoarthritis and to pursuing new medical indications to help patients manage pain from OA,” said Ann Merrifield, president of Genzyme Biosurgery, the business unit of Genzyme that manufactures Synvisc. “With approval in the ankle and shoulder, Synvisc will be one of the few viscosupplements available in Europe for treating OA pain in four major joints that is supported by strong clinical data.”

The filing for label expansion of Synvisc contains data from two clinical trials in the ankle and shoulder. The prospective, multi-center studies that took place in several countries throughout Europe found treatment with Synvisc to be well-tolerated. Data show that Synvisc significantly decreases pain due to OA in the ankle and shoulder, and that the decreased pain effect is maintained for up to six months.

Data from the ankle study have been accepted for presentation at the American College of Rheumatology meeting this fall in Washington. Genzyme said it expects the European regulatory review of the Synvisc label expansion request to be complete by year-end. Synvisc is marketed in more than 60 countries and has been used to treat more than 3 million people.

Study backs use of BSD-2000

BSD Medical (Salt Lake City) said a newly published study conducted in Berlin involving 137 patients with advanced rectal cancer has shown that the addition of cancer treatments with the company's BSD-2000 system to radiation and chemotherapy treatments did not result in any statistically significant adverse effect on patient quality of life compared to patients who received radiation and chemo-therapy without the added treatment. The company said it was “highly pleased” with the findings, “especially in light of the substantial reduction of patient quality of life that can accompany other cancer therapies.” BSD develops cancer treatment technology designed to make cancer treatment more effective without adversely impacting the quality of life for patients during treatments.

The study was conducted using the Gastrointestinal Quality-of-Life Index (GIQLI), an instrument validated and tested for its reproducibility and sensitivity in measuring quality of life for patients suffering from malignant and benign diseases of the gastrointestinal tract. The GIQLI contains 19 questions pertaining to symptoms of disease, five questions relating to emotional well-being, seven questions regarding physical function, four questions that assess social function and six questions that measure the perception of the medical treatment.

Of the 137 patients in the Berlin study, 68 (49.6%) received treatments with radiation, chemotherapy and the BSD-2000 and 69 (50.4%) were treated with radiation and chemotherapy alone.

BSC said the global GIQLI scores showed no significant differences at any time pertaining to quality of life for the two groups.

Chasing next-generation stents

Axordia (Sheffield, UK) reported plans for the clinical application of one of its proprietary stem cell lines in a next-generation stent that will prevent restenosis without the increased risk of late-stage thrombosis that can occur with existing drug-eluting stent (DES) devices. The company will collaborate with Lombard Medical Technologies (Oxford, UK) in the development of the so-called “regenerative” stent. The project will involve combining Axordia’s stem cell-derived endovascular cells with Lombard’s polymer coating, which can be programmed for the timed release of the active ingredient.

The current generation of DES devices is design-ed to restrict local vascular repair following angioplasty. That prevents restenosis, an inflammatory thickening of the artery. However, recent evidence suggests that in higher rates of thrombosis, a clot forms at the end of the stent. It is believed clot formation is linked to the delayed healing of the blood vessel. Axordia said the endovascular cell line will promote healing at the site where the stent is implanted while at the same time reducing inflammation and creating a localized immune-privileged site to prevent the body from rejecting the stent.

Alistair Taylor, Lombard’s chairman, said there is “significant potential” for a regenerative stent that will reduce restenosis without prompting late-stage thrombosis. “A system that engenders normal healing of the tissues may reduce these late complications.”

It would be the first clinical application of Axordia’s stem cell technology.