• Boston Scientific (Natick, Massachusetts) reported two-year results from its RENAISSANCE study, which was designed to evaluate the safety and effectiveness of the company's Express SD Renal Stent in hypertensive patients with atherosclerotic renal artery stenosis (RAS). Results were presented at the All That Jazz conference in New Orleans. All patients in the study had a single, de novo RAS. The primary endpoint of the study was restenosis, or the re-narrowing of a previously stented vessel, at nine months. High technical and procedural success rates (99%) were achieved with excellent concordance (87%) between renal artery DUS and angiography for restenosis. The binary nine-month restenosis rate was 21.3%.

• Cytyc (Marlborough, Massachusetts) reported that five-year follow-up results for the initial clinical trial of the MammoSite radiation therapy system (RTS) were presented at the 8th Annual Meeting of the American Society of Breast Surgeons (ASBS). Qualified patients with early-stage breast cancer were prospectively enrolled and treated using the MammoSite RTS as the sole modality for delivering accelerated partial breast irradiation (APBI). From May 2000 to October 2001, forty-three patients completed APBI with MammoSite RTS and to date, thirty-six remain in the study. The study also evaluated patient acceptance of the procedure. Survey results showed that 100% of patients said they would recommend MammoSite brachytherapy to a friend or family member and all patients said they would use MammoSite brachytherapy again if they had to do it over. Cytyc makes products targeting women's health and cancer diagnostics.

• Impliant (Princeton, New Jersey) reported positive results on a series of 32 TOPS system patients with the longest follow-up to date of two years. The TOPS is a total posterior arthroplasty device for patients suffering from debilitating leg and back pain stemming from spinal stenosis, a common back condition that may also be accompanied by degenerative spondylolisthesis and facet arthrosis. Impliant's TOPS system is a mobile posterior device designed to stabilize but not fuse the affected vertebral levels to alleviate pain stemming from spinal stenosis, which is the narrowing of the spinal canal and the impingment of nerve roots. The disease may be accompanied by degenerative facet arthrosis-where the joints becomes inflamed and worn-and by spondylolisthesis, or the pain-inducing slip of one vertebral body forward relative to the adjacent vertebrae. Following a decompression of the lamina and medial facets to remove the bone elements pressing on nerves, the device is affixed to the spine via four pedicle screws using a standard posterior surgical approach. Impliant is a privately held company that makes spine arthroplasty solutions for motion preservation.

• Luna Innovations (Roanoke, Virginia) reported that it has submitted its 510(k) application to the FDA for the EDAC (emboli detection and classification) Quantifier. This product uses quantitative ultrasound technology to non-invasively count and measure gaseous emboli in the extracorporeal blood circuits. The Quantifier is designed to reliably detect harmful gaseous emboli during open-heart surgery. Gaseous emboli are air bubbles that may enter or are created in the blood circuit during critical and invasive medical procedures such as cardio-pulmonary bypass surgery. Luna Innovations is a technology development company focused on sensing, advanced materials, and systems integration.