• Cook Women’s Health (Spencer, Indiana) reported the launch of its newest product, the Cook cervical ripening balloon. It is designed to offer safe, comfortable cervical preparation (ripening) without the threat of drug-based side effects or interactions. Labor is induced in more than 18% of deliveries in the U.S. and is commonly used in the instance of a post delivery date pregnancy. If labor is induced when the cervix is unfavorable it may increase the likelihood of induction failure, protracted and exhausting labors, and other complications. An undesired Cesarean delivery may also result. The Cook cervical ripening balloon catheter is comprised of two silicone balloons and engineered to allow the cervix to naturally and gradually dilate prior to the induction of labor. The first of two balloons is inflated on the uterine side of the cervix; the second is then inflated in the vaginal side of the cervix. The two balloons adapt to the contour of the cervical canal minimizing discomfort for the patient. When the catheter is removed, cervical conditions should have improved to a favorable state to allow for induction of labor and active labor management. Cook Women’s Health, a subsidiary of Cook Medical, specializes in OB/GYN devices.

• CryoLife (Atlanta) and BioForm Medical (San Mateo, California) reported that the first patient has been enrolled in a clinical study evaluating BioGlue surgical adhesive as a method of fixation in brow lifts. BioForm recently received IDE permission from the FDA to initiate enrollment in a feasibility study to evaluate the safety and effectiveness of BioGlue as a method for tissue fixation in patients undergoing browplasty procedures (sometimes described as brow lifts). BioGlue is a two-component adhesive that creates a flexible, mechanical seal, independent of the body’s clotting mechanism, within 20 to 30 seconds, and reaches its maximum bonding strength in two to three minutes. It is FDA-approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels. BioForm, a privately held medical aesthetics company, and CryoLife, a biomaterials, medical device, and tissue processing company, entered into a licensing and distribution partnership for the production of CryoLife’s BioGlue surgical adhesive for its potential use in cosmetic and plastic surgery indications.

• Delcath Systems (Stamford, Connecticut) reported the expansion of its Phase II multi-histology clinical trial to include a fourth arm consisting of patients with metastatic melanoma in the liver who have previously received isolated hepatic perfusion (IHP), but whose cancer has since relapsed. The trial is testing use of the Delcath system for the organ-specific delivery of the chemotherapeutic agent, melphalan, in patients with specific tumors in the liver, including primary liver cancer, metastatic neuroendocrine tumors and adenocarcinomas in the liver. The Delcath system is used to perform percutaneous hepatic perfusion (PHP), which uses a series of catheters and an external blood filtration apparatus to deliver high doses of chemotherapeutic agents to a tumorous liver while significantly removing the toxic drugs from the patient’s blood, thus restricting its systemic circulation throughout the patient where it would cause unacceptable and possibly fatal side effects. The added arm of the trial, which is independent of the other arms, allows Delcath to assess the effect of PHP therapy on patients who previously responded to high-dose melphalan, but later experienced a relapse with one or more tumors growing back. Patients who previously responded to the therapy are considered good candidates to respond again. Delcath Systems makes percutaneous perfusion technology for organ- or region-specific delivery of therapeutic and chemotherapeutic agents.