A Medical Device Daily
SenoRx (Irvine, California) said it has received the CE mark for its Contura MLB (Multi-Lumen Radiation Balloon) short-term breast radiation balloon catheter. The multi-lumen radiation balloon delivers radiation to the tissue surrounding a lumpectomy cavity following surgery for breast cancer.
The CE mark applies to both the original size Contura MLB, designed for lumpectomy cavities of 4 cm to 5 cm in diameter, as well as the more recently cleared, larger Contura Shape Select MLB, designed for cavities ranging from 4.5 cm to 6 cm.
SenoRx received 510(k) clearance in the U.S. for the original Contura in May 2007 and for the larger-size Contura in July 2008.
"The CE mark [for] Contura further strengthens our long-term international growth opportunities," said Lloyd Malchow, company president/CEO. He said the company already is marketing the EnCor Breast Biopsy system and GelMark line of tissue markers through local distributors with breast imaging and/or radiology franchises in more than 30 markets outside the U.S.
"While Contura is currently only being sold in the U.S., we can now begin implementing commercialization plans for the product internationally," Malchow said. "We expect to launch Contura in several countries outside the U.S. in 2009 and further expand internationally in a step-wise manner.'"
The company noted that the Contura MLB is an example of a new class of devices that, for "appropriate patients," can reduce treatment time to five days from six to eight weeks.
SenoRx said it believes the Contura MLB may play an important role in the shift from traditional whole breast radiation therapy to localized partial breast radiation therapy. Some patients who are potential candidates for balloon therapy are currently excluded because of the location of the lesion and their breast size, but the ompany said Contura's multi-lumen design "may address this issue for certain patients."
SenoRx's line of breast care products includes biopsy disposables, biopsy capital equipment, diagnostic adjunct products and therapeutic disposables.
BD unit's OcuSeal now on market
BD Medical-Ophthalmic Systems (Waltham, Massachusetts), a unit of BD (Becton, Dickinson and Co.), reported the European launch of BD OcuSeal Liquid Ocular Bandage, a synthetic protective barrier designed to provide comfort for post-surgical, post-traumatic, and non-traumatic ocular conditions.
BD OcuSeal Liquid Ocular Bandage is designed to help reduce the need for sutures and reduce complications typically associated with surgical incisions, including infection and patient discomfort. It is intended for direct application on corneal, conjunctival, and scleral surfaces.
The product has CE-mark approval, and BD said it intends to initiate registration in other countries, including the U.S.
BD OcuSeal Liquid Ocular Bandage consists of a synthetic hydrogel that is applied directly to the ocular surface as a liquid, using a special brush applicator. The hydrogel is activated by mixing two separate components.
The company said the product is engineered to form a low-profile, smooth, soft and transparent protective barrier film on the ocular surface.
"With the addition of BD OcuSeal Liquid Ocular Bandage to the BD family of single-use ophthalmic products, BD continues to demonstrate its commitment to improving patient safety during ophthalmic surgery," said Doug Lawrence, vice president and general manager, BD Medical-Ophthalmic Systems.
BD has an exclusive license from Hyperbranch Medical Technology (Durham, North Carolina) to market BD OcuSeal Liquid Ocular Bandage for use in ophthalmology.
BSI Healthcare launches FastTrack Review
Saying that it is responding to client feedback, BSI (Reston, Virginia) reported the launch of a new speed-to-market program, CE-Onsite FastTrack Review, for Class III medical devices needing European CE-mark Design Dossier Reviews.
BSI Product Services, Healthcare said this new program will expedite the review process through live, onsite interaction, facilitating more efficient communication as well as the goal of completing the review in 45 working days.
The CE-Onsite has the same features of the CE-45 FastTrack Program, with one main difference: BSI product experts visit a manufacturer's premises to perform the review. The company said that performing reviews onsite allows for a much faster timeline while still maintaining the same high quality.
"This face-to-face opportunity provides product experts [with] accessibility to all relevant parties, from engineers to regulators, and supports dynamic communication, immediate access to documentation and in-person viewing of the new product," BSI said.
It noted that some products such as medicinal, blood and animal tissue products require the use of outside agencies and may not be eligible for CE-Onsite Review.
While BSI's goal is to complete the review with either a positive or negative recommendation within 45 working days, it said the length of the review "greatly depends on the degree to which the manufacturer is prepared. In order to make the review as effective as possible, clients should have a strong motivation to get their product to market and excellent documentation, and be well-organized and responsive to questions."
"The interactive aspect of the CE-Onsite FastTrack Review compresses the review time, improves the predictability of the review's outcome, and promotes a faster time-to-market," said Ibim Tariah, technical director of BSI, Healthcare.