The World Ophthalmology Congress is in session this week in Hong Kong. At the event, Marie-Jose Tassignon, MD, spoke about her work with an intraoccular lens. The device was developed specifically for children to minimize contact with biomaterial that can cause lens epithelial cell damage and the resulting loss of elasticity in the capsular bag (the complete story can be found here).
The three pieces of the lens create a groove around the optic and between the haptics where the IOL can secure the edges of both the anterior and posterior capsulorrhexis, leaving the only contact of the lens with the capsular bag edges.
The surgical procedure to implant the lens consists of standard cataract removal with the exception of her technique for anterior and posterior capsulorrhexis, which she performs with the aid of a specially designed tension ring, Tassignon said. She admitted that the procedure requires more skill and is more difficult than standard cataract removal procedures.
CardioTech International Inc., a developer and manufacturer of advanced biomaterials, announced today that it has formed AdvanSource Biomaterials Corp. to align the firm’s strategic focus. The subsidiary was formed in anticipation of a company name change and is subject to stockholder approval later in 2008.
CardioTech’s CEO Michael Adams said in a press release, “AdvanSource Biomaterials reflects more accurately our strategic business model which focuses our advanced polymer technology and customization capabilities on a broad range of disease states and medical device sectors.” In connection with its restructuring during the past year, CardioTech has sold two subsidiaries that no longer fit its strategic focus, resulting in the firm having approximately $7.5 million in cash.
Phase IIb trials have begun for Kuros Biosurgery AG’s product KUR 113. The material is being used to treat acute open tibial shaft fractures.
According to the company, KUR-113, is a modified variant of parathyroid hormone (PTH) incorporated into a fibrin sealant. When mixed together, the bioactive and the sealant generate a fibrin composite that forms to the shape of the bone defect.
KUR-113 is applied to the site of the fracture following surgical fixation with intramedullary nailing or plating. The investigational product is designed to gradually release PTH from the matrix to stimulate bone-forming cells, promote bone formation, and accelerate fracture repair.
The Phase IIb clinical trial is a multicenter, randomised, controlled, open label (dose-blinded) dose-finding study that will evaluate the efficacy and safety of KUR-113 as an adjunct to current standard of care in the treatment of patients with acute open tibial shaft fractures. Patients will be recruited from approximately 30 centers across Europe. The study will compare the proportion of patients healed six months after treatment with various doses of KUR-113 as an adjunct to surgical management versus surgical management alone.
KUR-113 is licensed to Baxter under a collaboration and license agreement that was signed in 2005. Under the terms of this agreement, recruitment of the first patient into this study triggers a milestone payment to Kuros.
Heparin used to clean intravenous lines has been linked to 11 deaths and more than 80 reports of harmful side effects, reports Bloomberg news. However, the problems may not all be caused by contaminated product, Karen Riley told Bloomberg. The heparin associated with two of the 11 deaths wasn’t contaminated, and the FDA can’t say conclusively say how many of the other deaths and side effects involved tainted heparin, according to Riley. Riley said the 11 deaths involving devices are “probably in addition” to the 81 [deaths associated with contaminated heparin], though some of the reports to the FDA are “very sketchy” and there could be “some minor overlap.”
So the jury is still out as to how much this affects devices and whether device makers should continue to recall products.
Along with MD&M East (June 3-5) there are a few shows in June you may want to attend:
BIO 2008 International Convention, June 17-20 in San Diego, CA.
Investment in Innovation (IN3) Medical Device Summit, June 17-19 in San Francisco, CA
ASME Frontiers in Biomedical Devices Conference, June 18-20 in Irvine, CA.
Pancreatic cells wrapped in a biomaterial could be key to the next stage in diabetes management. The Cardiovascular Innovation Institute, has received a $1.3 million grant from the NIH to study this type of pancreatic cell transplants.
If successful, the transplants could be used as a means for managing cardiovascular disease and diabetes, the university said in a news release.
The cell transplant process involves encasing pancreatic cells in a porous biomaterial that protects cells from the immune system but allows glucose and insulin to pass through the material to keep the cells functioning while awaiting transplantation.
