A CDU

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 designed to restrict local vascular repair following angioplasty. That prevents restenosis, an inflammatory thickening of the artery. However, recent evidence suggests that it results in higher rates of thrombosis, where 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, chairman of Lombard, 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 well reduce these late complications.”

It would be the first clinical application of Axordia’s stem cell technology. The company, which spun out of Sheffield University, has concentrated on developing cell lines for use in drug discovery and in refining and developing GMP-grade manufacturing processes for stem cells.

Paul Gerskowitch, CEO of Axordia, said the collaboration is evidence that the company is in a leading position in delivering safe clinical applications for stem cells. Another UK stem cell company, NovaThera, is taking a similar approach to commercializing clinical applications of stem cells, by working with manufacturers of artificial lung and heart machines.

Axordia and Lombard agreed to collaborate on the project over the next 2 1/2 years, but did not reveal the terms of the agreement. The current global market for DES devices is estimated at $6 billion.

Zenith endograft okayed in Japan

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 Cook’s 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 Inc.,” 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, the largest-selling AAA endograft in the world, 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 Kichikawa, 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 abdominal 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.

According to third-party market research data, the Zenith AAA Endovascular Graft is the largest-selling device of its kind in the world.

HemoCue rolls out white blood cell system

HemoCue (Angelholm, Sweden) has unveiled an entirely new single-analyte point-of-care (POC) testing system for determination of total white blood cell count.

The new system was on display at July’s American Association of Clinical Chemistry (Washington) annual meeting in Chicago. The company said the test is so simple that it can be performed in any physician’s office within minutes and will be, it added, “a valuable tool in the diagnosis of bacterial infections.”

The HemoCue WBC testing system for total white blood cell (WBC) count will be used to rapidly diagnose infections and will substantially improve quality in primary care, the company said. Instead of sending blood samples to a reference lab, the system will provide immediate and reliable results with the same precision and accuracy as a lab test, onsite and within minutes, HemoCue said.

Since an increased total WBC count is typically seen in patients with bacterial infections, HemoCue WBC will assist physicians in the decision on whether to prescribe antibiotics or not. The company said over-prescription of antibiotics is a major concern resulting in an increasing number of bacterial strains being resistant to antibiotics.

“Our new point-of-care system for measuring total WBC will help physicians prescribe antibiotics to patients in need of it without unnecessary delay and to avoid prescribing it to patients where it has no effect,” says Stellan Lindberg, director of R&D at HemoCue. “So far we have presented HemoCue WBC to a small number of experts at large central hospital laboratories and to physicians in primary care settings. They have been very impressed by the simplicity and accuracy of our system.”

The WBC system is based on HemoCue’s proven cuvette technology and is specifically designed for receiving a waived categorization under the U.S. government’s Clinical Laboratory Improvements Amendments program. The system will be tested on a large scale in the beginning of next year by a number of clinics in Sweden and the U.S., with anticipated commercialization in 2Q07.

HemoCue is owned by EQT, a leading Northern Europe private equity group.

UK trial set for Vascular Wrap/Lifespan

Angiotech Pharmaceuticals (Vancouver, British Columbia) said it would begin enrollment in a clinical trial in the UK to assess the effectiveness and safety of the Vascular Wrap paclitaxel-eluting mesh and Lifespan graft technology platform in hemodialysis patients. The company received a “letter of no objection” from the Medicine and Healthcare Products Regulatory Agency, a unit of the UK Department of Health.

The trial seeks to determine that hemodialysis patients who receive the Vascular Wrap paclitaxel-eluting mesh/Lifespan graft combination product experience fewer graft failures than those patients that receive the Lifespan graft alone. As a combination product, the graft serves as an access port for hemodialysis and the intent of the drug-eluting mesh is to prevent the scar formation that often leads to graft failure.

Angiotech said it expects to enroll the first patient in the trial in the next eight weeks. The company also intends to conduct a similar trial in the U.S. Both studies are expected to be about 24 months in duration, with enrollment taking about one year.

The goal of the studies is to provide Angiotech with sufficient data to submit to regulatory authorities for the approval to market the products in the U.S. and Europe.

A substantial portion of the patients who undergo hemodialysis require vascular access, often achieved by surgically implanting a vascular graft to enable treatment. Angiotech said about 50% of grafts fail within one year and about 75% within two years as a result of scar formation.

“We have been very encouraged by both the preliminary results from the European bypass trial and the results of our preclinical data, and believe that we may be able to offer a better treatment option for hemodialysis patients,” said Dr. Rui Avelar, chief medical officer at Angiotech. “We hope to improve the quality of life for these patients, who through the course of their treatments often have to endure multiple surgeries to replace AV grafts that have failed due to blockage caused by scar formation.”

Dr. William Hunter, president and CEO, said, “We believe that hemodialysis is just one indication where the Vascular Wrap paclitaxel-eluting mesh may produce better outcomes for patients, with peripheral bypass surgery being another.”

The Vascular Wrap paclitaxel-eluting mesh/Lifespan graft combination product is designed to be used as a port for hemodialysis access or as a bypass for a blocked artery. The Vascular Wrap component is a biodegradable mesh implant incorporating Angiotech’s paclitaxel technology in a novel biomaterial with the goal of mitigating scar formation caused by graft implantation and thereby potentially enhancing graft patency rates in AV-access patients as well as in peripheral bypass procedures.

FDA okays heart valve work in Sorin plant

Sorin Group (Milan, Italy), a leader in cardiac surgery solutions, has received clearance from the FDA to manufacture mechanical heart valves offered by its CarboMedics (Austin, Texas) unit in the company’s manufacturing facility in Vercelli, Italy, in the Saluggia region.

The inspection performed by FDA representatives on the Sorin Group’s Heart Valves Business represented what it termed “a fundamental step in the industrial integration and consolidation process of the group.”

While the production of mechanical cardiac valves has been consolidated in one manufacturing facility in Saluggia, the company’s facility in Austin will continue to serve as the assembly location of finished products for the North American market.

Sorin said this production shift would enable it to benefit from economies of scale and exploit the technological know-how developed through the work carried out in Saluggia over several decades. “Since 1977, hundreds of thousands of mechanical valves have been manufactured at Saluggia, and have been implanted in more than 70 countries without any structural malfunction,” the company said.

Franco Vallana, president of the Cardiac Surgery Business Unit, said the benefits that this integration effort is expected to include greater operational flexibility in managing brands and product lines, enabling the company to respond to any shifts in market demand; economies of scale and reduction of manufacturing costs; and greater integration between the manufacturing and R&D organizations.

Drago Cerchiari, Sorin’s CEO, said, “This production relocation will result in a strategic reinforcement of the overall cardiac valves area, which will benefit from the world’s greatest concentration of medical technology resources and product-specific know-how.”

Sorin Group has about 4,800 employees working at facilities in more than 80 countries throughout the world.

Principal investigator signed for trial

CardioTech International (Wilmington, Massachusetts) reported signing an agreement with a principal investigator for the European clinical trial of its CardioPass synthetic coronary artery bypass graft.

CardioTech’s newly named CEO, Michael Adams, who also is responsible for regulatory affairs and business development, said the unnamed investigator “has participated in a wide range of cardiovascular clinical trials. This decision, [which] fits within our planned timeline, is an important benchmark in the commencement and completion of the trial.”

CardioTech previously has hired a European-based contract research organization to assist in the organization, execution and completion of the clinical trial in the European Union. As reported earlier, CardioTech is moving forward with its approved protocol to conduct a clinical trial of 10 patients with a post-operative follow-up period of 90 days.

“With the selection of a principal investigator, we can now apply for ethics committee and Ministry of Health approvals, which are needed before import licenses and other administrative paperwork can be completed. Patient enrollment for the trial is expected to begin by year-end,” Adams said.

CardioTech develops products for the treatment of cardiovascular, orthopedic, oncology and other diseases. CardioPass is the company’s synthetic coronary artery bypass graft.

UK fair-trade office eyes U.S. firms

The UK Office of Fair Trading (OFT) has received a complaint about three Minneapolis-area companies allegedly involved in price fixing, but hasn’t started a formal investigation yet, a spokeswoman said last month.

London’s Sunday Times reported the OFT is looking into whether Medtronic (Minneapolis), St. Jude Medical (St. Paul, Minnesota) and Boston Scientific’s Guidant division (also St. Paul) allegedly colluded to boost the prices paid by the UK’s National Health Service for pacemakers. The UK Department of Health recently sought bids for pacemakers, and none of the three companies that control an estimated 90% of the U.S. market submitted “valid’” bids, according to the Sunday Times.

A Boston Scientific spokesman told the newspaper the company’s actions were appropriate and in the best interests of doctors and patients. A Medtronic spokesman said the allegations “are wholly fabricated.”

A spokeswoman for the Department of Health said the agency has asked the Office of Fair Trading to “consider issues relating to the operations of the market,” but declined to comment further.