A Medical Device Daily
Micrus Endovascular (San Jose, California) said it has received the CE mark for its Pharos stent, which will allow the company to begin marketing the stent for the treatment of ischemic and hemorrhagic stroke.
Micrus said it expects to immediately begin selling the Pharos stent in the European Union and all countries recognizing the CE mark, through its direct sales and distribution network.
The Pharos stent was developed and will be brought to market under an agreement between Micrus Endovascular and Biotronik (Berlin, Germany) reported in January.
John Kilcoyne, president and CEO of Micrus, said the introduction of the Pharos stent “provides our customers with a new tool to treat both ischemic and hemorrhagic stroke.“
He said the stent is “the first of several products we plan to jointly develop and market using Biotronik's technology.“
Claus Martini, CEO of Biotronic, said the approval of the companies' first collaborative product “is a testament to our synergistic relationship with Micrus Endovascular. We are delighted to see our technology move beyond the cardiovascular and peripheral vascular intervention markets, and look forward to introducing additional products through our collaboration.“
Micrus Endovascular manufactures both implantable and disposable medical devices used in the treatment of cerebral vascular diseases. Its products are used by interventional neuroradiologists and neurosurgeons, primarily to treat cerebral aneurysms responsible for hemorrhagic stroke.
'Limited trial' seen for CardioPass in Europe
CardioTech International (Wilmington, Massachusetts) said its European Notified Body has requested that the company acquire additional clinical data to support its submission for CE mark approval of the CardioPass artificial coronary artery graft for use with “no option“ patients.
In response to that request, CardioTech said it is in the process of planning a limited clinical trial in Europe. The company plans to expand the initial indication for use of the CardioPass graft from just “no option“ patients to pati-ents who present with suboptimal (diseased or inferior) vessels discovered while undergoing surgery.
CardioTech said it believes that up to 15% of the 600,000 patients who undergo bypass surgery worldwide each year have suboptimal vessels.
The company said the expanded indications would allow surgeons to determine during a bypass operation if the patient has the required native vessels of sufficient quality to complete the revascularization. Currently, when a surgeon is unable to identify such native vessels during the time that a patient can “reasonably“ be kept on bypass, the surgeon is often forced to complete the operation utilizing suboptimal vessels, CardioTech said.
It said the clinical availability of the CardioPass graft would offer the surgeon the ability to choose during the procedure to utilize the CardioPass to complete the needed revascularization.
Michael Szycher, PhD, chairman and CEO, said, “We regard this response by the notified body as an important, positive milestone to obtaining marketing approval in Europe for the CardioPass graft.“
He said CardioTech believes it is the only company that is actively seeking regulatory approval for a synthetic coronary artificial bypass graft to address what he characterized as “the growing, unmet need for today's bypass patients who have advanced coronary disease.“
Data collected during the European trial also may be used to support the company's application to obtain an Investigational Device Exemption (IDE) in the U.S.
In addition to CardioPass, CardioTech has partnered with CorNova to develop a drug-eluting coronary stent.
Ablatherm-HIFU use grows in UK
EDAP TMS (Lyon, France), a major provider of products for high-intensity focused ultrasound (HIFU) treatment of localized prostate cancer, reported “significant growth“ in the number of sites offering Ablatherm-HIFU treatment in the UK.
The company said that since its formal launch at Guy's Hospital (London) in December, the number of sites having access to Ablatherm-HIFU has increased from three to 13 throughout the UK. EDAP said its UK partners, Sigmacon and Mobile HIFU , are experiencing “strong interest and rapid growth,“ especially in greater London.
Dr. Declan Cahill of Guy's Hospital said patients like the treatment option that EDAP's Ablatherm-HIFU is offering. Patient satisfaction is “very high,“ he said, adding that the hospital has had “a significant increase in inquiries concerning Ablatherm-HIFU in recent weeks.“
Hugues de Bantel, CEO of EDAP, said, “We are seeing strong interest from the UK urology community in offering Ablatherm-HIFU as a treatment choice because of its clear history of successful outcomes with minimal side effects and recovery periods as compared to other therapeutic choices.“
Ablatherm-HIFU technology was developed and perfected in Europe, with more than 9,000 clinical treatments to date. Studies have shown that Ablatherm-HIFU has had success rates up to 93%, with up to five years of follow-up, the company said.
Prostate cancer is the leading cancer among UK men, with more than 35,000 new cases diagnosed each year.
Synova listed on Frankfurt exchange
Synova Healthcare Group (Media, Pennsylvania), developers and distributors of rapid over-the-counter and point-of-care diagnostic tests, reported that its shares have also been listed on the Frankfurt Stock Exchange under the symbol S7H, and the security number US87163H1023.
“European investors have recently shown strong interest in our corporate mission, our product portfolio and our management team at Synova Healthcare,“ said CEO Stephen King. “The Frankfurt exchange listing will provide both institutional and retail investors in Europe with a direct ability to trade our company's shares, further enhancing our liquidity and visibility.“