A Medical Device Daily

Innocoll (Ashburn, Virginia) said its sales and marketing subsidiary, Innocoll Pharmaceuticals (Athlone, Ireland), has received approval from the Federal Institute for Drugs and Medical Devices in Germany for marketing a new version of its CollaRx Gentamicin Surgical Implant in that country.

The implant, sold in Germany under the trade name Sulmycin Implant E, previously was available in 10 cm x 10 cm and 5 cm x 5 cm sizes. The new version is 20 cm x 5 cm, and according to Innocoll is the only product of its type available in that size.

The company said it developed the new size to provide "optimal flexibility" to the surgeon, as the product is used across a broad range of surgical specialties.

Gentamicin is a biodegradable, leave-behind implant impregnated with the broad-spectrum aminoglycoside antibiotic, gentamicin, and is indicated as an adjunct to systemic antibiotic therapy for the treatment and prevention of post-surgical acquired infection in both hard and soft tissues.

The product was developed using Innocoll's collagen-based technology, CollaRx, and has been approved in 49 countries.

The Gentamicin implant was the first gentamicin-collagen sponge on the market, the company said, and is the only such product approved as a medicinal product in the world.

Innocoll said more than 50 prospective clinical trials and published case reports have documented the safety and efficacy of the product over a broad variety of orthopedic, abdominal, colorectal, cardiothoracic, vascular and neurosurgical procedures totaling more than 7,500 patients.

One such clinical study, the Local Gentamcin Infection Prophylaxis (LOGIP) trial involving 2,000 patients undergoing a full median sternotomy during cardiac surgery, demonstrated that the Gentamicin implant reduced the incidence of sternal wound infection (SWI) by 53% when used as an adjunct to the standard infection prophylaxis, intravenously administered isoxazolyl-penicillin.

Innocoll noted that post-operative sternal wound infection is a serious, potentially life-threatening complication of cardiac surgery. It is a major cause of morbidity and "adds significantly to the length of a hospital stay and associated cost of care," the company said.

The LOGIP trial was performed at two hospital centers in Sweden, led by Organ Friberg, MD, cardiothoracic surgeon at Orebro University Hospital. Patients in the treatment group had two Gentamicin implants placed between the sternal halves before closure. Each implant contained 130 mg of gentamicin, corresponding to a total dose of 260 mg.

The primary endpoint — total incidence of SWIs after two months post-surgery — was 9% in the control group and 4.3% in the treatment group.

Denise Carter, president of Innocoll, said, "Germany is a key market for us. The product was first invented and developed in Germany and continues to be manufactured at our production plant in Bavaria. We are pleased to have received our first drug approval for the new product size in Germany, and we look forward to subsequent approvals in other European countries."

Four Centers of Excellence for MDS Nordion

MDS Nordion (Ottawa), a provider of medical isotopes and radiopharmaceuticals used to diagnose and treat disease, has established four Centers of Excellence in Europe for TheraSphere, its liver cancer treatment.

TheraSphere, which received the CE mark in June, is a therapeutic medical device used in Europe for the treatment of liver cancer, including hepatocellular carcinoma (HCC), the most common form of primary liver cancer; or secondary liver cancer that has migrated to the liver from another location.

The centers — BCLC Group Hospital Clinic (Barcelona, Spain); Center Eugene Marquis (Rennes, France); University Hospital Essen (Essen, Germany); and University of Pisa (Pisa, Italy) — will educate oncology professionals on the use of the technique.

Comprised of millions of tiny glass beads containing radioactive yttrium-90, TheraSphere is injected into the main artery of the patient's liver using a catheter. The beads become lodged in the small blood vessels that feed the tumor and deliver a therapeutic dose of radiation directly to the cancer while minimizing impact on the patient's healthy tissue.

"Primary liver cancer can be difficult to treat, as it is frequently accompanied by poor liver function resulting from other conditions such as hepatitis or cirrhosis," said Dr. Jordi Bruix, director of BCLC Group Hospital Clinic. "TheraSphere is an option that is especially ideal for patients where surgery or transplantation is not possible."

Dr. Jean-Luc Raoul, oncology professor in the Medical Oncology Department at Center Eugene Marquis, said, "In this age of targeted therapies, TheraSphere allows us to deliver a therapeutic dose of radiation directly to the cancerous tumor while minimizing the impact on a patient's healthy tissue."

According to the National Cancer Institute, HCC is the fourth-most-common cancer in the world.

"The development of TheraSphere Centers of Excellence is a significant step toward making this innovative cancer therapy more widely available to a greater number of patients in Europe," said Steve West, president of MDS Nordion.

Agenda outlined set for NICE's 13th program

The UK's National Institute for Clinical Excellence (NICE) is being asked to develop technology appraisals for new treatments for breast cancer, rheumatoid arthritis, obesity and Crohn's disease as part of its 13th work program.

The institute's technology appraisal and clinical guideline work programs are set by the Department of Health. Topics for referral include both new and emerging health technologies and those drugs, devices and procedures currently in use in the NHS where there is variation in practice. Topics are selected against published criteria.

Health Minister Andy Burnham said NICE's 13th work program would provide "valuable advice on issues important to the NHS."

He said the Department of Health also is asking NICE to produce guidance on the storage of donated kidneys.

"Donated organs are a particularly precious resource," Burnham said, "and it is important to ensure that the NHS has the best possible information available on the most effective ways to store and preserve them."

NICE has produced guidance on 205 pharmaceuticals, 63 procedures, 17 diagnostics, five health promotion programs and 113 devices. The majority of appraisals by the organization have suggested partial or full use of technologies.