A Medical Device Daily
HyperBranch Medical Technology (Durham, North Carolina) said it has received a CE mark for its OcuSeal product, providing regulatory approval for the company to begin sales in Europe and potentially all other countries outside the U.S.
HyperBranch describes OcuSeal liquid ocular bandages as providing a protective barrier while stabilizing ocular wounds following surgical or non-surgical trauma and other ocular conditions.
OcuSeal is intended for direct application on corneal, conjunctiva, and sclera surfaces to provide a temporary protective barrier in post-surgical, post-traumatic, and non-traumatic ocular conditions. The single-use device is terminally sterilized and allows for a one-handed brush application.
“Having the opportunity to begin sales is a major milestone for any small, developing company,” said John Conn, president/CEO. “It validates years of research and provides a revolutionary product not previously available to healthcare providers.”
The HyperBranch OcuSeal product is synthetic hydrogel which polymerizes in a moist field, flows optimally depending on the application, and is bio-degradable as the tissue re-establishes itself. The biocompatible composition is stored at room temperature and is delivered through the custom applicator to meet the specific needs of the procedure.
The intended users of OcuSeal are ophthalmologists in a surgical or clinical environment.
Hyperbranch also has been developing advanced surgical sealants for dura (brain), pleural, and hernia mesh fixation. These products are all at various stages of clinical and pre-clinical development.
High marks for Genous stent in Italian study
Patients who received OrbusNeich’s (Hong Kong) pro-healing stent, the Genous Bio-engineered R stent, had significantly fewer major cardiac adverse events (MACE) than patients who received Boston Scientific’s (Natick, Massachusetts) Taxus or Johnson & Johnson’s (New Brunswick, New Jersey Cypher drug-eluting stents in a study conducted at Federico II University of Naples (Naples, Italy).
The results of the study were presented recently at the national congress of the Italian Society of Invasive Cardiology by Federico Piscione, MD, the study’s principal investigator and a professor with the university’s Division of Cardiology, Department of Clinical Medicine and Cardiovascular Sciences.
“Our findings suggest that the deployment of Genous stents in a consecutive series of high-risk patients is safe and effective, with a significantly lower in-hospital incidence of MACE and a better long-term clinical outcome when compared to drug-eluting stents,” said Piscione. “Genous is a viable alternative to drug-eluting stents, which have raised many safety concerns among the interventional cardiology community”
The study involved 195 high-risk patients who underwent percutaneous coronary intervention with either Genous or Cypher/Taxus implantation at the university’s cath lab.
At 10 months’ follow-up, the cumulative MACE rate for the Genous group was 4% vs. 22% for the combined Taxus and Cypher group. For the MACE components, the cumulative rate of target vessel revascularization was 1% for GRS vs. 11.8% for DES, the cumulative rate of myocardial infarction was 1% for GRS vs. 7.8% for DES, and the cumulative mortality rate was 2% for GRS vs. 7.8% for DES. In addition, the cumulative rate for stent thrombosis was 2% for GRS vs. 5.8% for DES.
The Genous stent is coated with an antibody to capture a patient’s endothelial progenitor cells (EPCs), which OrbusNeich said “accelerates the natural healing process.” EPCs circulate in the bloodstream and are involved in the repair of blood vessels. “When attracted to the surface of the Genous stent, EPCs can form an endothelial layer over the stent to provide protection against thrombus and minimize restenosis,” the company said.
U.S. firm buys German tubing maker
Saint-Gobain Performance Plastics (SGPPL; Aurora, Ohio), said it has acquired IFK Isofluor (Neuss, Germany), a private manufacturer of fluoropolymer tubing. Specific terms were not disclosed.
IFK supplies Isofluor brand products to global industrial and medical customers from two European locations. Saint-Gobain is planning to integrate the IFK business into its Process Systems business unit, which is part of SGPPL’s Fluid Systems division. IFK and the Isofluor brand products will be marketed consistent with past practices, the U.S. company said.
“IFK Isofluor is an excellent fit within SGPPL and we are pleased to welcome them to our company,” said Tom Kinisky, SGPPL president. “IFK has a strong brand identity and complements the products of SGPPL. Dieter Heuser and his son, Holger Heuser, have built a very strong business. We look forward to continuing the tradition which started in 1984 long into the future.”
Saint-Gobain Performance Plastics is part of Saint-Gobain (Paris), a major producer of construction products, flat glass, high-performance materials and packaging, and Europe’s largest distributor of building materials. Saint-Gobain had worldwide sales of more than $52 billion in 2006, and has more than 207,000 employees in 56 countries.
New distributors for Third Wave’s HPV test
Third Wave Technologies (Madison, Wisconsin) said Inverness Medical Iberica, the Spanish affiliate of Inverness Medical Innovations (Waltham, Massachusetts), will distribute Third Wave’s HPV high-risk screening test in Spain and Portugal.
Third Wave described Inverness Medical Iberica as a leader in the marketing of diagnostics to assist laboratory and health care professionals in both preventive and interventional medicine.
Third Wave also said that four well-known regional distributors have been secured to distribute its HPV product in Italy.
“Third Wave has taken another significant step forward in our HPV commercialization plans with the appointment of our first European HPV test distributors,” said Kevin Conroy, president/CEO. “Inverness Medical Iberica provides [us] with a well-established, substantial sales force in Spain and Portugal, both key countries driving HPV testing growth in Europe, [and] Third Wave is just as pleased to have secured Italian distribution of our HPV product through a team of outstanding and well-recognized regional distributors in that country.”