US-based medical devices and support services company Medline is expanding its Honea Path, South Carolina production facility that produces a synthetic polyisoprene material called Isolex
by 30% to support the increased demand in latex-free alternative gloves, the company said.
One solution has been positive magnetic enrichment of CD34+ HSCs from the graft, initially by Isolex
300i and later by the CliniMACS device [14-17].
Baxter is also working to resolve an outstanding warning letter it disclosed last year over the marketing of its Isolex
devised used in cancer therapy, Reuters reported.
The letter referred to Baxter's Isolex
device used in cancer therapy, according to Baxter spokeswoman Mavis Prall.
In terms of product development activities, the company completed enrollment in a Phase II clinical trial using Baxter's proprietary Isolex
technology to select CD34+ adult stem cells from patients with chronic myocardial ischemia re-infusion into their hearts as a means to restore blood flow.
- Screening of patients to complete enrollment in a Phase II trial using Baxter's proprietary Isolex
technology to select CD34+ adult stem cells to improve symptoms and clinical outcomes in patients with chronic myocardial ischemia, a severe form of coronary artery disease.
In his ruling, Harold Varmus, MD, Director of the NIH, wrote, "NIH concludes that Hopkins and Baxter have taken effective steps to achieve practical application, as demonstrated by Hopkins' licensing, Baxter's manufacture, practice and operation of the Isolex
300, and the device's availability to and use by the public.
The chronic granulonmatous disease program is developing a proprietary cellular therapy, utilizing the Isolex
300I Magnetic Cell Selection System, to produce a stem cell transplant to treat a rare, life-threatening inherited blood disorder.
Maxxim Medical's new powder-free and latex-free SensiCare surgical gloves are made with ISOLEX
, a synthetic polyisoprene polymer developed by Maxxim that has a molecular structure identical to natural rubber latex.
Nexell Therapeutics, Inc., a majority-owned subsidiary of VIMRX Pharmaceuticals, Inc., Irvine, CA, announced the Therapeutic Products Program of Health Canada ahs issued a medical device license to the company for the sale of the Isolex
300 and Isolex
300I cell selection systems.
300 Cell Separator System, licensed by Nexell Therapeutics, Irvine, CA, is in widespread use in clinical trials in the US and is currently under review by the FDA.
Nexell's lead product, the Isolex
Cell Selection System, enables clinicians to select peripheral blood CD34+ stem cells, from which neutrophil precursors are produced.