A Medical Device Daily
Innocoll (Ashburn, Virginia) said its wholly-owned subsidiary, Innocoll Pharmaceuticals, has received a class IV medical device license for its CollaRx Gentamicin Surgical Implant from Health Canada, the Canadian regulatory authority.
The company said it now is in a position to commercialize the Gentamicin implant in Canada, where it has been registered under the trade name, Collatamp G.
Dr. Michael Myers, president/CEO of Innocoll, said, "We are currently finalizing plans for early commercialization in Canada and anticipate the product will be available later this year."
Gentamicin Surgical Implant is a biodegradable, leave-behind surgical implant impregnated with the broad-spectrum aminoglycoside antibiotic, gentamicin.
The product was developed using Innocoll's collagen-based CollaRx technology, and has been approved in 49 countries as either a medicinal product for the treatment and prevention of surgical site infections or as a medical device. It is currently in Phase III clinical development in the U.S. for the prevention of surgical site infections.
Innocoll said that the safety and efficacy of the Gentamicin Surgical Implant have been documented in about 60 clinical trials and case studies involving a broad variety of orthopedic, abdominal, colorectal, cardiothoracic, vascular and neurosurgical procedures totaling more than 7,500 patients.
One such clinical trial — the Local Gentamcin Infection Prophylaxis (LOGIP) trial — involving 2,000 patients undergoing a full median sternotomy during cardiac surgery, demonstrated a 53% reduction in the incidence of sternal wound infection (SWI) when used as an adjunct to standard infection prophylaxis. The prospective, randomized, controlled clinical study was performed at two hospital centers in Sweden and led by Dr. Orjan Friberg, cardiothoracic surgeon at Orebro University Hospital.
Patients in the treatment group had two Gentamicin implants (260 mg total dose) placed between the sternal halves before closure. 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. Sub-population analysis of known high-risk groups showed even greater treatment effect, including a 68% reduction in infection from 17.3% in the control group to 5.6% in the treatment group for patients with diabetes.
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.
Trials set for China Sky diagnostic kits
China Sky One Medical (Harbin, China), a manufacturer of diagnostic, pharmaceutical and medicinal products in China, reported that eight of its new diagnosis kit products will enter into the clinical trial stage this month.
- Rapid Diagnosis Kit for Human Urine Microalbumin: Rapid, semi-quantitative testing of urine microalbumin, used for detecting early-stage kidney damage.
- Urine One Step LH Test for self-testing at home, forecasting the ovulation cycle as a reference point to help improve the success rate of being impregnated or to use contraceptives, or to assist in diagnosis of barrenness.
- Rapid Detect Kit for Prealbumin, a semi-quantitative testing of the percentage of human prealbumin, which is a crucial value for diagnosing substantial damage to the liver.
- Rapid Detect Kit for APO B, semi-quantitative testing of the percentage of APO B contained in human blood serum.
- Rapid Detect Kit for APO A1, semi-quantitative testing of the percentage of APO A1 contained in human blood serum.
- Rapid Detect Kit for Magnesium Ion, to test the percentage of magnesium ion, which helps diagnose renal inadequacy, uremia etc.
- Semi-quantitive Uterine Cancer One Step Test to detect cancer cells early and to monitor the state of post-treatment.
- Semi-quantitive Calcium Ion, a semi-quantitative testing of the percentage of calcium ion contained in human blood serum, blood plasma, urine and breast milk.
The Semi-quantitive Uterine Cancer on Step Test is classified as Class III medical instrument, while the other seven products are classified as Class II. The clinical trials in China will test sensitivity and specificity.
For Class II instruments, each trial will involve at least two provincial hospitals and 200 patients. For Class III instrument, it will involve at least three provincial hospitals and 1,000 patients. All of the trials are expected to be completed by the end of 2007.
Micrus in distribution agreement
In other news from China, Micrus Endovascular (San Jose, California) reported signing a five-year, exclusive agreement with Beijing Tian Xin Fu Medical Appliances (TXF Medical), for the distribution in China of Micrus' implantable and disposable medical devices used in the treatment of neurovascular diseases.
Micrus said it expects to begin distributing its products in the Chinese market through TXF Medical upon receiving regulatory approval.
Under the terms of the agreement, TXF Medical will distribute Micrus' full product line throughout China. Micrus said it plans to introduce its products during the World Federation of Interventional and Therapeutic Neuroradiology meeting in Beijing next month.
TXF Medical, founded in 1995, has established a marketing group composed of doctors and nurses with experience in clinical medicine and customer service. The TXF team has cooperated closely with specialized products manufacturers offering products and services in neurosurgery, orthopedics and cardiovascular sectors.
"With approximately 7,500 endovascular procedures performed in Chinese hospitals last year and a countrywide procedure growth rate estimated at 25% to 30% China is the world's fastest-growing neurointerventional market," said John Kilcoyne, Micrus Endovascular president and CEO. "Our entry is a significant milestone in our drive to be the premier neurointerventional company in the world."
Micrus manufactures and markets implantable and disposable devices used in the treatment of neurovascular diseases, used by interventional neuroradiologists and neurosurgeons, primarily to treat cerebral aneurysms responsible for hemorrhagic stroke.