Contura MLB Approved Cleared for Marketing
SenoRX, Incorporated received an additional marketing approval from the Food and Drug Administration for the company’s Contura MLB short-term breast radiation balloon. The company has a new device that was launched.
Benefits of the new Contura Multi-Lumen Radiation Balloon (MLB) Catheter include improved flexibility to fit the balloon catheter within the lumpectomy cavity. Availability of this tool is consistent with a new treatment approach; delivering breast therapy in a localized manner, rather than treating the entire breast.
The Contura allows treatment of patients eligible for balloon therapy who may otherwise be excluded with current devices because of the breast size and location of the malignant lesion. In particular, the Contura’s multi-lumen system allows these patients to undergo balloon radiation.
The Contura also includes a vacuum which is used to remove excess air and seroma. This improves the conformance of the lumpectomy cavity. This supports more precise delivery of radiation treatment through the different radiation source lumens.
The product was initially approved by the FDA in May 2007, described on HospitalBuyer. The Contura system was cleared to support delivery of radiation therapy to tissue around the area where lumpectomy to remove breast cancer was performed. One benefit of this system is ability to decrease the timeframe that patients undergo radiation treatment, from six weeks to just five or six days.
July 2, 2008 Related topics: Product Approval & Certification, New Technology & Innovation, Quality, Safety, Errors, Surgery, Hematology & Oncology