SAVI Wins Award for Medical Design Excellence

Cianna Medical's Design and Engineering Expertise Is Honored

ALISO VIEJO, Calif. — Cianna Medical announced that the SAVI® breast brachytherapy applicator has received a 2010 Medical Design Excellence Award.

Now in its thirteenth year, The Medical Design Excellence Awards competition is the only awards program that exclusively recognizes contributions and advances in the design of medical products.

"The entire Cianna Medical team is proud to receive the 2010 Medical Design Excellence Award for its SAVI breast brachytherapy delivery system," said Jill Anderson, Cianna's president and CEO. "Our passion for innovation and commitment to women's health is what drives our creativity and desire to develop medical technologies that are transforming breast cancer treatment through improved quality, better outcomes and more convenient options for women. We are grateful to the MDEA sponsors for recognizing our achievements."

The SAVI applicator is used in accelerated partial breast irradiation (APBI), a shortened course of high-dose radiation therapy for early-stage breast cancer patients following lumpectomy surgery. Used as part of breast conservation therapy, the treatment is completed in just five days - compared to the six weeks of treatment required for traditional external-beam radiation.

The device's unique multi-catheter design allows physicians to precisely target radiation where cancer is most likely to recur while minimizing exposure to healthy tissue, and it is the only single-entry device that enables physicians to sculpt the dose based on patient-specific anatomy. Clinical studies show this increased flexibility and SAVI's open architecture design lead to better patient outcomes, including less skin toxicity, lower persistent seroma rates and a reduced risk of infection.

"The device makes it possible for us to shape the dose to the dimensions of the lumpectomy cavity, which minimizes toxicity to non-targeted tissue," said Rakesh Patel, M.D., a radiation oncologist at El Camino Hospital, in Mountain View, Calif. and incoming president of the American Brachytherapy Society "My patients can expect fewer complications and better cosmetic results than with previous first-generation devices. The technology is impressively well designed."

Unlike other devices, SAVI has no skin spacing restrictions, allowing physicians to offer the benefits of brachytherapy to the widest array of women. Studies show that nearly twice as many women can be safely treated with SAVI compared to other methods, like balloon brachytherapy.

"SAVI's innovative design enables me to treat women who would not be eligible for APBI with other methods," said Richard Fine, MD, a breast surgeon based in Marietta, Ga. "Most women who meet the clinical guidelines for APBI can be treated with SAVI, making it a major advance in our field."

In addition to recognizing the innovative design of medical devices, the MDEA competition also honors the suppliers - including design firms, materials suppliers, component manufacturers and consulting firms - that assist in the development of MDEA-winning products. Cianna Medical works with a number of companies that play a vital role in the production of the SAVI applicator, including:

  • Azure Microdynamics (Lake Forest, Ca.), a leader in the fabrication of custom small and miniature components and assemblies for medical devices;
  • Zeus Medical (Orangeburg, Sc), a leader in the development and production of high-performance fluoropolymer tubing, as well as providing innovation in post-production finishing and strategic supply initiatives;
  • Modified Polymer Components (Sunnyvale, Ca.), specializing in the design, rapid prototyping and manufacture of reliable, highly precise polymer components for Medical Device OEMs, as well as companies in the electronics, aerospace, biotech, semiconductor and other related industries with plastics needs;
  • Fort Wayne Metals (Fort Wayne, In.), a recognized leader in the research, development and production of fine grade medical wire.

The 2010 Medical Design Excellence Award winners will be honored at a presentation ceremony on Wednesday, June 9, 2010 in New York City's Jacob K. Javits Convention Center, in conjunction with the Medical Design & Manufacturing (MD&M) East Conference and Exposition (www.MDMEast.com), June 8-10, 2010. Gold and silver award recipients will be announced at this time.

MDEA Award entries are evaluated on the basis of their design and engineering features, including innovative use of materials, user-related functions that improve healthcare delivery and change traditional medical attitudes or practices, features that provide enhanced benefits to the patient, and the ability of the product development team to overcome design and engineering challenges so the product meets its clinical objectives.

A comprehensive review of the entries was performed by an impartial, multidisciplinary panel of third-party jurors with expertise in biomedical engineering, human factors, industrial design, medicine, and diagnostics.

About Cianna Medical, Inc.

Cianna Medical, Inc. is a medical device company focused on women's health and dedicated to the innovative treatment of early-stage breast cancer. The company manufactures and markets the SAVI breast brachytherapy applicator, for the delivery of radiation after lumpectomy surgery. The SAVI applicator allows precise contouring of the radiation dose, and is designed to make the benefits of accelerated partial breast irradiation available to a greater number of women.

For more information, call (toll-free) 866-920-9444 or visit www.SAVI.us.