A Medical Device Daily Staff Report
SI-Bone (San Jose, California), a company developing a minimally invasive surgical (MIS) device to treat the sacroiliac (SI) joint said it is launching training for its iFuse Implant System and anticipates CE mark "at anytime." The company is introducing the system at the Eurospine meeting in Vienna this week.
SI Bone has already received ISO 13485 certification, it noted.
European surgeon training sessions are scheduled for October and November in Salzburg, Austria. These sessions will be presented by surgeon faculty who have performed dozens of iFuse surgeries in the U.S. and be coordinated by Vanes Frison, the company's European training and product manager.
Last month, the company closed on an $11 million financing round for the expansion of clinical and commercial operations. New investor Skyline Ventures of Palo Alto, California led the round.
Jeff Polack, VP of marketing at SI-Bone, told Medical Device Daily at that time that the company plans to "greatly expand" its sales and marketing efforts by offering additional direct representation in select markets while also expanding its hybrid model and continuing to work with major spine distributors. He added that SI-Bone is also expanding its presence in Europe because it is close to having a CE mark for the iFuse implant (Medical Device Daily, Aug. 19, 2010).
On the clinical side, Polack noted that the company's iFuse implant received FDA 510(k) clearance at the end of 2008 and because there were predicate devices, extensive clinical trials were not required. However, he said that so far, the early clinical data looks promising so SI-Bone is launching a study called MISSION in the U.S., which will be a prospective, multicenter, on-label study looking at the clinical and economic efficacy of the iFuse implant.
The iFuse system is comprised of titanium implants coated with a porous plasma spray that acts as an interference surface fit, which helps decrease implant motion. According to the company, the iFuse has a substantial thickness and sophisticated metallurgy, which provide immediate post-operative fixation, accomplishing the goal of traditional open SI Joint fusion through an MIS approach.
"The CE mark will allow our EU team to develop a presence in selected EU markets to address the needs of physicians committed to treating patients with SI joint problems," said Jeff Dunn, president/CEO of SI-Bone. He added that the company "looks forward to entering these markets because we offer the only technology which provides an MIS solution to treat these SI joint conditions."
The iFuse is indicated for use in fracture fixation of large bones and large bone fragments of the pelvis for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
U-Systems wins CE mark for somo-v
U-Systems (Sunnyvale, California) reported winning approval to market its somo-v automated breast ultrasound (ABUS) system as an adjunct to mammography for screening asymptomatic women for breast cancer in the European Union.
"This represents a major advancement in breast health for women as study after study have demonstrated a need for additional tools to improve the early detection of breast cancer, particularly in women with dense breast tissue which impacts detection and carries an increased risk of breast cancer," said Ron Ho, president/CEO of U-Systems. He added that the system is not intended as a replacement for mammography, "which remains the most effective screening tool for many women."
U-Systems is sponsoring the SOMO INSIGHT study, designed to evaluate whether digital mammography in combination with the somo-v is more sensitive than a routine screening mammogram alone in detecting breast cancer in women with greater than 50% dense breast tissue. To date, more than 9,000 women have participated in the study, which is actively recruiting up to 20,000 women at multiple breast imaging centers in the U.S.
SpineAlign enrolls first patient in VerteLift study
SpineAlign Medical (San Jose, California) said it has enrolled its initial patient in an observation study to further assess the ability of the VerteLift system to treat the pain and dysfunction associated with osteoporotic vertebral compression fractures (VCF), while providing clinically measurable height restoration based upon previous European experience and analysis. On Aug. 30, Frank Hassel, MD, Loretto-Hospital (Freiburg Germany) surgically treated the first patient in the multi-center observation registry. VerteLift is SpineAlign's first CE mark product in commercial release outside the U.S. It is a transpedicular, minimally invasive approach to reduction, stabilization and pain relief associated with vertebral compression fractures.
Rainer receives CE mark for Cadisc-L
Ranier Technology (Cambridge, UK) says it has received CE mark approval for its Cadisc-L, an elasto-mimetic spinal disc replacement device for the lumbar spine. The approval was received following a review of the company's multi-center European study and its "extensive portfolio" of biocompatibility and biomechanical testing, Ranier noted.
"The initial outcomes in the clinical study are very pleasing. By using the Cadisc-L spinal disc replacement, we found patients had significant reductions in average leg and back pain, and overall disability, and coupled with an increase in quality of life there are very strong indications of early phase performance," said Ian Quirk, director of clinical and regulatory affairs at Ranier.
Cadisc-L is intended to treat degenerative disc disease of the lumbar spine.
Accentus inks deal with Zimmer for Agluna
Accentus Medical (Oxford, UK) said it has signed a license and services agreement with Zimmer (Warsaw, Indiana) that will enable the use of Accentus Medical's Agluna anti-infective technology on a potentially broad range of Zimmer products.
Zimmer will acquire exclusive global rights to use Agluna for joint reconstruction and trauma products. In addition, the company will have an 18-month option to acquire additional rights for spinal devices, dental implants and sports medicine products. There will be an initial period of further development of Agluna. Accentus and Zimmer will collaborate to secure regulatory approval for products treated with the Agluna technology in both Europe and the U.S. Financial details of the agreement were not disclosed.
Agluna is a surface modification technology applied to medical devices manufactured from titanium and its various alloys. The goal of the technology is to reduce infection rates following surgical procedures.