• I-Flow (Lake Forest, California) reported that two recently published studies of post-surgical pain relief after hernia surgery were featured at the recent annual meeting of the American Hernia Society (Orlando, Florida) in San Diego. In both studies — in the Journal of the American College of Surgeons (February 2005) and American Surgery (October 2004) — patients undergoing invasive inguinal hernia surgery who received pain relief with ON-Q realized a significant reduction in pain, vs. patients in placebo groups, and in the need for narcotics following surgery. ON-Q PainBuster consists of a small balloon pump that holds a local anesthetic delivered through a tiny catheter directly into the surgical site. The ON-Q Soaker Catheter is designed to provide more even distribution of local anesthetic over a wider area, as compared to other catheters, because of its wicking capabilities. I-Flow reports more than 40 studies on the use of ON-Q completed and published and more underway to demonstrate the benefits of ON-Q in additional areas such as pediatrics and wound healing. I-Flow develops drug delivery systems and services for pain relief.

• NanoHorizons (State College, Pennsylvania), a developer of applied nanoscale materials and solutions, reported receiving a patent covering its deposited thin-film system for high-throughput, small-molecule mass spectrometry. QuickMass-enhanced targets enable MALDI mass spectrometers to be used for accurate and convenient small-molecule analysis using matrix-less and thin-layer matrix test techniques. Dr. Stephen Fonash, founder of NanoHorizons, said, “Tens of millions of compounds are analyzed annually. QuickMass-enhanced targets can rapidly impact a research lab or pharmaceutical company's bottom line and time to market.“

• Ortec International (New York) said the FDA has completed a review of the modified Diabetic Foot Ulcer (DFU) Protocol the company submitted to the agency on Jan. 6 and has given Ortec permission to initiate a pivotal trial evaluating OrCel in the treatment of diabetic foot ulcers. The DFU trial is expected to be conducted at up to 25 clinical centers and involve about 200 patients. The company said it expects to initiate patient enrollment shortly after receiving approval of its premarket approval application for the use of OrCel in the treatment of venous leg ulcers (VLU), currently under FDA review. Ortec said the FDA has asked it to provide further clarification of information submitted in its PMA application for VLU. The company said it expects to meet with the agency shortly to review the information submitted. OrCel is composed of a collagen sponge seeded with allogeneic epidermal and dermal cells. These cells secrete growth factors and cytokines normally found in acute human wounds and are believed to have a beneficial role in promoting tissue repair, the company said.

• St. Jude Medical (St. Paul, Minnesota) reported the European market launch of the QuickSite 1056T bipolar left-heart pacing lead, which it described as “the world's first cardiac resynchronization therapy (CRT) lead to combine bipolar pacing capability with a composite body for superior handling and an S-shaped distal tip for outstanding stability.“ St. Jude said the lead represents the next advance in its QuickSite family of left-heart leads. Designed for placement in the coronary sinus, the QuickSite 1056T bipolar lead enables left-ventricular pacing in cardiac resynchronization therapy applications. At 5.5 Fr, the lead body is as small in diameter as the previously available QuickSite 1056K unipolar lead and is designed to work with the St. Jude Medical Epic HF CRT-D, which the company said is the world's smallest high-voltage cardiac resynchronization device, and the Atlas+ HF CRT-D, the world's highest energy output CRT device, to treat heart failure. It also will work with the recently released Frontier II biventricular cardiac stimulation device. The lead has been submitted to the FDA for approval in the U.S.

No Comments