A CDU

Rubicon Medical (Salt Lake City) said in mid-April that it had received the CE mark for its Rubicon Filter, an embolic protection system that traps and removes debris that may be dislodged during interventional procedures.

The product, which will be marketed and distributed in Europe by Boston Scientific (Natick, Massachusetts), has been cleared for commercialization in three indications saphenous vein grafts (SVG), native coronary arteries and carotid arteries as well as in three sizes: 4 mm, 5 mm and 6 mm filters.

To treat patients who have blood vessels partially or fully occluded with plaque buildup on the vessel walls, surgeons will often utilize a small wire mesh tube known as a stent to prop open the target vein or artery. When used in conjunction with a stenting procedure, the Rubicon Filter is maneuvered into place and deployed downstream from the blockage prior to the delivery and opening of the stent, with the goal of allowing surgeons to capture and remove dislodged plaque from the blood vessel during and after the stenting procedure. Studies have identified such dislodged plaque (or embolic material) as a potential cause of heart attacks, stroke, kidney failure and death.

Rubicon Medical conducted two parallel clinical trials in Europe the RULE-SVG study RULE-Carotid study in support of its CE mark filing.

"This is a big day for Rubicon Medical. We have been working diligently in preparation for this approval," said Richard Linder, president and CEO. "The Rubicon Filter performed marvelously in both native and SVG procedures, as well as in carotid applications.

Paul LaViolette, chief operating officer of Boston Scientific, called the Rubicon Filter "a potential paradigm-shifting technology due to its low profile and ease of use."

The RULE-SVG study included 54 patients with either saphenous vein graft disease or coronary artery disease in the native coronary arteries, including a number of high-risk stenting procedures. Those procedures were performed at hospitals in Germany and Italy, with many of the studies conducted by Eberhard Grube, MD, chief of interventional cardiology at Heart Center Siegburg (Siegburg, Germany).

In the RULE-Carotid study, the Rubicon Filter was used in 60 procedures with patients suffering from significantly blocked carotid arteries, the main vessels in the neck, which feed blood directly to the brain. The procedures were performed at hospitals in Germany, with Joachim Schofer, MD, co-founder of the Center of Cardiology and Vascular Intervention (Hamburg, Germany), as the principal investigator.

Eucomed lauds EC research proposal

The European medical technology industry association, Eucomed (Brussels, Belgium), said that it "welcomes" a European Commission (EC) proposal for a decision of the European Parliament concerning the 7th Framework Program for Research 2007-2013, published last month. The association said it believes that what it termed "this ambitious project" will contribute to "achieving excellence in scientific and technological research in the medical technology field."

Maurice Wagner, the organization's director general, said, "We are pleased to see that a particular emphasis has been placed on the development and validation of new therapies, diagnostic tools and technologies, as well as on efficient and sustainable healthcare systems. This project will provide our industry with new opportunities to improve patient care."

Eucomed said that in its proposal, the EC "clearly recognizes the need to increase the competitiveness of European health-related industries and businesses through the creation of an environment favorable to the small- to medium-sized, research-based companies that are the main drivers of the medical technology industry.

The association said it also welcomes that special attention given to nanotechnology and emerging technologies, "as this is another area where the medical technology industry is very active today." Eucomed said nanotechnology "offers new hopes for cancer treatment," citing the example of ongoing development of coated nanoparticles that can be injected into cancer-binding and cancer-fighting cells and then be activated by external devices, e.g. magnetically at the cancer site.

Human tissue engineering is "another fascinating medical technology with huge potential for the future," the association said. Tissue-engineered products could soon provide viable treatments for cardiovascular diseases, which cause about 50% of all deaths today.

Eucomed said research is currently under way in the field of heart-tissue regeneration, for example. With donor and mechanical heart valves encountering such problems as limited durability, shortage of supply and the inability to grow (posing a problem for childhood patients), the association said tissue-engineered valves will avoid these problems, being living replacements, capable of growing with the patient.

Research also is being undertaken to develop blood vessels capable of replacing natural vessels or to grow patches of heart muscle tissue to replace damaged tissue, Eucomed said.

PMA submitted in Japan

ThermoGenesis (Rancho Cordova, California) said that its distributor of the CryoSeal Fibrin Sealant System in Japan, Asahi Kasei Medical, has completed its pre-market approval (PMA) submission to the Ministry of Health, Labor and Welfare. The PMA submission followed completion of a clinical trial involving use of the CryoSeal FS system on cardiovascular, orthopedic, neurosurgery and esophageal surgery patients.

The CryoSeal FS System is used to prepare hemostatic and adhesive surgical sealants from patients' own blood in about an hour. The fibrin sealant market in Japan is currently estimated at about $130 million a year, according to ThermoGenesis.

Kevin Simpson, president and chief operating officer, said the PMA filing "is a key milestone in the development of the CryoSeal System as a new, safe, alternative source of surgical sealant for Japan, the world's largest market for conventional fibrin sealants." Noting that conventional fibrin sealants "are prepared from 'pools' of thousands of units of purchased plasma and bovine lung tissue," Simpson said that recent reports in Japanese medical journals "have identified these pooled products as a source of parvovirus B19 when transmitted to patients and is a cause of hemolytic anemia."

ThermoGenesis also said that it has reached agreement with Asahi for distribution of the TPD, a small, hand-held disposable that produces 8 cc of activated thrombin from 10 cc of patient blood plasma in about 30 minutes. Thrombin is a blood-clotting enzyme that surgeons use for topical hemostasis, the treatment of pseudoaneurysms and to form "platelet gels" for the treatment of damaged tissue.

Chairman and CEO Philip Coelho said that this disposable device allows surgeons to treat patients with thrombin manufactured from their own blood, instead of bovine thrombin that has been reported in peer-reviewed journal articles to cause immune reactions and severe bleeding episodes. He said that although these health risks and additional concerns about "mad cow" disease have nearly ended the clinical use of bovine thrombin in Europe and Japan, the U.S. and the rest of the world utilize more than $180 million worth of such products annually.

The CryoSeal FS System also has received CE mark approval. The system is not available for sale in the U.s., where it currently is being tested to control bleeding in a Phase III liver resection trial at eight clinical sites.

Boston Sci launches 'full range' of DES sizes

Boston Scientific (Natick, Massachusetts) reported last month that it has received CE marking for three large-vessel sizes (4 mm, 4.5 mm and 5 mm) of its Taxus Express2 paclitaxel-eluting coronary stent system in Europe and other international markets. Previously, the largest drug-eluting stent (DES) system size available was 4 mm, which limited clinicians' options for treating patients with large vessels, according to the company. It said that the launch of the three large-vessel Taxus DES devices completes its line of sizes available in Europe and international markets, thus making it "the first company to offer a full range of stent sizes."

The company said it would launch the new sizes immediately and continue to supply all sizes of its Taxus systems. "With CE mark approval for large vessel sizes, we are now able to provide physicians a full complement of drug-eluting stent sizes featuring the safety, efficacy and outstanding deliverability of the Taxus system," said Paul LaViolette, Boston Scientific's chief operating officer.

The Taxus system received CE-marking in January 2003, and it received FDA approval in March 2004. It said it expects to receive FDA approval for its large-vessel Taxus stent sizes in the first quarter of 2006.

In January 2005, the company reported that it had launched its Taxus Libert paclitaxel-eluting DES, featuring the company's next-generation Libert coronary stent, in 18 countries. The company plans to launch the Taxus Libert system in Europe later this year and in the U.S. next year, subject to regulatory approval.

European trial begins

Cardiovascular Systems (Minneapolis) said the first 12 patients have been enrolled in the European clinical trial of its Orbital Atherectomy System for the treatment of peripheral artery disease.

The first-ever use of the device in patients was performed by Horst Sievert, MD, director of the CardioVascular Center at Sankt Katharinen Hospital (Frankfurt, Germany) on March 29. Thomas Zeller, MD, of Herz-Zentrum (Bad Krozingen, Germany), began treating patients last week. The trial is expected to enroll up to 65 patients at up to four centers.

The Orbital Atherectomy System uses a diamond-coated, eccentrically rotating cutting surface to ablate tissue. Cardiovascular Systems said the resulting particles are small enough to pass through capillaries and be eliminated by the body.

The company is working on obtaining FDA clearance for use of the device in peripheral vascular disease and for use in coronary arteries. It has previously received FDA clearance to remove tissue-causing stenosis in synthetic arterio-venous shunts. It said it expects to conduct initial market testing at a limited number of clinical sites before undertaking full commercial release of the product for that indication.