Medtronic Launches VenaSeal Closure System
Medical device giant Medtronic has launched its VenaSeal closure system in the U.S. The minimally invasive VenaSeal procedure uses a medical adhesive to close superficial veins of the lower extremities in patients with symptomatic venous reflux. It is the first and only nontumescent, nonthermal, nonsclerosant procedure approved to treat symptomatic venous reflux in the U.S., the Irish devicemaker says. The system is available in the U.S., New Zealand, Chile, South Africa, Australia, Canada, Europe, United Arab Emirates and Hong Kong.
Boston Scientific Purchases Radiology Portfolio
Boston Scientific has reached an agreement to acquire the interventional radiology portfolio of CeloNova Biosciences. Under the transaction — which consists of an upfront payment of $70 million with the potential for additional milestone payments — Boston Scientific will acquire microspheres designed to be loaded with chemotherapy drugs for delivery to cancerous tumors and spherical embolic products for the treatment of uterine fibroids and other conditions. The transaction is expected to close by the end of 2015.
FDA Grants Indication Clearance to Si-Bone’s
San Jose, Calif.-based Si-Bone has received FDA clearance to include in the iFuse implant system’s indication statement that the device improved pain, patient function and quality of life at 12 months post-implantation. This addition was based on a series of prospective and retrospective clinical studies, according to the company. The iFuse system is a minimally invasive surgical device indicated for sacroiliac fusion for certain disorders of the sacroiliac joint.
Biological Dynamics Secures Financing
Molecular diagnostics company Biological Dynamics has completed a round of $26.8 million Series C financing to advance regulatory clearance for its lead oncology diagnostic program, the TR(ACE) assay, and for general working capital purposes. The financing was led by a large institutional investor associated with a major university. Existing investors Heritage Group, Alexandria Venture and Irwin Jacobs also participated in the round. The San Diego, Calif.-based diagnostics company has incorporated alternating current electrokinetics technology in the field of molecular diagnostics. For example, its lab-on-chip platform isolates nanoparticles from high conductance physiological solutions such as whole blood, plasma and serum directly without the need for dilution. The TR(ACE) assay uses the platform to assist clinicians in evaluating whether a patient undergoing cancer therapy is responding.
Roche Launches Ventana HE 600 System
Roche has unveiled its Ventana HE 600 system, a hematoxylin and eosin tissue staining system intended to enhance patient and technician safety. The system brings improved consistency and quality in tissue staining by delivering fresh reagents on each individual slide without relying on user-supplied alcohol and deionized water, according to the company. The system is now available worldwide, excluding Latin America. It will be available in that region in early 2016.