A Medical Device Daily
OrbusNeich (Hong Kong) reported that 5,000 patients treated with the company’s Genous stent at more than 120 sites in 29 countries are now enrolled in the global e-HEALING registry.
The company’s e-HEALING clinical study is a multi-center, worldwide (outside the U.S.) prospective registry of patients treated with the Genous Bio-engineered R stent.
The study protocol recommends that patients receive one month of clopidogrel treatment after the procedure. Clinical follow-up takes place at 30 days, six months and 12 months. The primary endpoint of the registry is target vessel failure at 12 months.
“We reached this significant enrollment milestone earlier than expected,” said Sigmund Silber, MD, co-principal investigator of the study. “This reflects an increase in demand and use for Genous by physicians concerned with drug-eluting stents [DES].”
Unlike drug-eluting stents, Genous is coated with an antibody that captures a patient’s endothelial progenitor cells (EPCs) to accelerate the healing process. EPCs circulate in the bloodstream and are involved in the repair of blood vessels. When attracted to the surface of Genous, EPCs rapidly form an endothelial layer over the stent that provides protection against thrombus and minimizes restenosis.
“Completing enrollment in this large registry is an important milestone in our clinical development,” said Samuel Rasmussen, OrbusNeich president and CEO.
OrbusNeich manufactures a variety of devices for the treatment of vascular diseases. In addition to Genous, those products include stents, balloons and guiding catheters marketed under the names of Blazer, R stent, Sapphire, Avita, Avita HP, SafeCut, Lumina and Saffron.
In addition to its Hong Kong headquarters, the company has operations in Fort Lauderdale, Florida; Hoevelaken, the Netherlands; and Shenzhen, China. OrbusNeich said it has provided cardiology devices to physicians through its predecessor companies since 1979, and today supplies products in more than 60 countries.
Japanese study eyes breast augmentation
Cytori Therapeutics (San Diego) said a new study under way in Japan will examine the effect of adult stem and regenerative cells derived from adipose tissue in breast augmentation.
In this investigational procedure, a patient’s breast is augmented with her own liposuctioned fat, which has been combined and enhanced with her own adipose-derived stem and regenerative cells. These cells are made available at the time of surgery using Cytori’s Celution System.
This independent, investigator-initiated study is being sponsored by Tatsuro Kamakura, MD, chief medical officer of Cosmetic Surgery Seishin in Japan. The study will enroll 20 patients, all of whom will undergo a standardized cell-enhanced fat tissue transplantation procedure.
Cytori said adipose tissue is “one of the body’s richest and most accessible sources of regenerative cells.” Adipose-derived regenerative cells include adult stem cells in addition to other important cell types that have been shown pre-clinically to improve tissue retention compared to non-cell-enhanced tissue transfers.
The company said these cells potentially may improve and simplify traditionally complex fat transfer procedures as well as enable more predictable outcomes and graph retention when applied to cosmetic and reconstructive surgery.
“This study further demonstrates the breadth of potential applications for the Celution System,” said Cytori President Marc Hedrick, MD. “A number of physicians like Dr. Kamakura are interested in exploring new applications for the Celution System through investigator-initiated studies. These studies will help accelerate and broaden the number of potential uses of the device and allow us in parallel to maintain our focus on the medical need of breast reconstruction in partial mastectomy patients.”
The company noted that clinical research is ongoing for breast reconstruction in partial mastectomy patients.
The Celution System was evaluated in an 11-patient investigator-initiated safety and feasibility study, designated as RESTORE I, conducted in Japan. That study evaluated adipose-derived stem and regenerative cells extracted and processed with the Celution System to treat the complications of surgery and radiation damage following partial mastectomy. Results will be reported at the San Antonio Breast Cancer Symposium on Dec. 15.
Based on preliminary findings and other data, Cytori is sponsoring two post-marketing studies, designated as the RESTORE II and VENUS studies, which will further evaluate the use of adipose-derived stem and regenerative cells for reconstruction of breast tissue following a partial mastectomy.
RESTORE II will evaluate up to 70 patients at multiple European trial sites. VENUS will be a 20-patient single center adjunct to RESTORE II in patients with more severe damage and contour defects resulting from a partial mastectomy.
Wright Medical system gets Japan okay
Japan’s Ministry of Health has approved Wright Medical Group’s (Arlington, Tennessee) Conserve Plus Hip Resurfacing System.
The system is available in Europe, Canada and Australia. It is not yet approved for use by surgeons in the U.S., although it is in the FDA’s regulatory approval pipeline.
Hip resurfacing allows the painful part of the hip joint to be surgically treated while retaining as much of the healthy bone as possible. Wright said its system has many sizing options and a larger-diameter femoral head it said helps give patients more range of motion and a more natural gait after surgery.
Wright Medical markets its products in more than 60 countries worldwide.
TSX okays listing for Response Biomedical
Response Biomedical (Vancouver, British Columbia) said the Toronto Stock Exchange (TSX) has conditionally approved the company’s application for listing its common shares on the exchange. Listing will be subject to the company filing satisfactory final documentation with the TSX.
Response manufactures rapid on-site diagnostic tests for use with its portable RAMP Platform for clinical and environmental applications. The system consists of a portable fluorescent reader and single-use disposable test cartridges. RAMP clinical tests are currently available for the early detection of heart attack and congestive heart failure.