A Medical Device Daily

Tryton Medical (Durham, North Carolina), a developer of stents designed to definitively treat bifurcation lesions, reported that the Tryton stent has been implanted for the first time in Portugal and Austria.

Francisco Pereira Machado, MD, of Hospital da Luz (Lisbon, Portugal) performed the first implant in Portugal.

"The Tryton Side Branch Stent is a simple approach to secure and dilate the side branch with optimal scaffolding of its ostium. Its use makes the placement and deployment of the main vessel stent easy," said Machado. "When there is involvement of both the main vessel and the side branch, and when, for any reason, you choose to go for two stents, think of dedicated stents. Keep it simple."

Olev Luha, MD, PhD, from the LKH University Hospital (Graz, Austria) was the first to use the stent in Austria and has implanted four Tryton stents during four different procedures.

"I am pleased to have had the opportunity to start using the Tryton Side Branch Stent. The Tryton is easy to use and allows for a predictable treatment of bifurcation lesions, which are some of the most complex lesions that we get to treat. Going forward, I will use the [stent] in my daily practice," said Luha.

The stent system is designed to offer a dedicated strategy for treating atherosclerotic lesions in the side branch at the site of a bifurcation. These areas of the vascular system are a common location for plaque and are particularly challenging to treat with currently available stent systems. About 22% of patients treated for coronary artery disease have diseased bifurcated lesions.

Tryton's highly deliverable cobalt chromium stent is deployed in the side branch artery using a standard single-wire balloon-expandable stent delivery system. A conventional drug-eluting stent is then placed in the main vessel.

The company said the system demonstrated excellent six-month clinical results in a first-in-man study of the system in 30 patients, with no restenosis occurring in the side branch artery. The stent system has received CE mark approval in Europe and is not approved in the U.S.

Genomic Vision inks pact for FSHD test

Genomic Vision (Paris), a biotechnology company focused on pioneering nanotechnology-based DNA analysis, said it has signed an agreement and received a 250,000 grant from the Association Fran aise contre les Myopathies (AFM; Evry, France) for the optimization and validation of a diagnostic test for facio-scapulo-humeral dystrophy (FSHD). The test, underpinned by Genomic Vision's Molecular Combing technology, is undergoing further development and validation in partnership with the Universit de la M diterran e (Marseille, France) and the Timone Hospital (Marseille). The collaboration harnesses the benefits of Molecular Combing technology and aims to make this test routine in the clinic. The test is designed to make a radical change to the ease and reliability of FSHD diagnosis, the company said.

Genomic Vision expects final results from the clinical study at the Timone Hospital, Marseille in the spring. Internationally, around 30 laboratories specialize in the molecular testing for FSHD. Genomic Vision will offer the test to both public and private specialists.

First Osseoplasty performed in Europe

Osseon Therapeutics (Santa Rosa, California) said it has completed its first Osseoplasty procedures in Europe. The procedures were performed in Milan, Italy.

Teaming with its European distributor MBA Incorporado (Gijon, Spain), the largest independent medical device distributor in Europe, Osseoplasty cases are also scheduled to begin in the next weeks in the U.K., Germany and Spain.

Osseon's product line features the Osseoflex (steerable and curvable needle) and Osseoperm (bone cement). These products combine to form a new procedure termed Osseoplasty to treat painful acute fractures of the vertebrae seen increasingly in older individuals with osteoporosis and osteometastatic injuries.

According to the compay, Osseoflex can access the entire vertebral body from a singular unipedicular percutaneous access point. The Osseoplasty system is unique for its delivery of optimal viscosity cement and precise cement placement through the highly maneuverable Osseoflex needle. The Osseoplasty procedure provides rapid stabilization of vertebral fractures and significant pain relief on the day of treatment, the company noted.

MBA will distribute Osseon's products to physicians and hospitals throughout the European Union, including the U.K, Germany, Spain, Portugal, Italy, Greece, Austria, Switzerland, Scandinavia, Turkey and Germany.

Professorship in gender medicine to be formed

How do gender differences influence the way in which patients are affected by disease? Should men and women receive the same treatments? Everyone's right to receive the best possible care regardless of gender is the underlying vision for a donation of SEK 10 million ($1.39 million) from Paul Lederhausen – the entrepreneur whose achievements include the establishment of McDonald's in Sweden. The donation will allow Karolinska Institutet (Stockholm, Sweden) to establish the Erica Lederhausen Professorship in Gender Medicine Research, one of the first professorships in the world in the field of gender medicine.

Gender medicine research has revealed biological differences between men and women that are crucial to how medical care and treatment should be designed. However, even though insight into medical differences between the genders has increased, both men and women are still affected by a lack of knowledge within gender medicine, in both care and research. For example, all studies of osteoporosis have been carried out on women, leading to the lack of guidelines for the treatment of men.

The Erica Lederhausen Professorship in Gender Medicine Research will be based at the Karolinska Institutet Centre for Gender Medicine, which was inaugurated in 2001 as the first centre for gender medicine in the world. The donation from Lederhausen will enable the center, under the leadership of the first incumbent of the professorship, Karin Schenk-Gustafsson, to undertake major new initiatives. The professorship will be directed towards research into gender differences for widespread public diseases such as cardio-vascular disease, cancer and psychiatric conditions, with respect to their causes, symptoms, treatments and prognoses.