A Medical Device Daily

CVRx (Minneapolis) has received CE-mark approval for its Rheos Baroreflex Hypertension Therapy System, which it said is the only implantable device designed to control hypertension.

The company said the system was approved for marketing in Europe based on clinical studies conducted in both Europe and the U.S.

CVRx said the Rheos System provides a “physiological rational” method to reduce blood pressure (BP), using the body’s own natural BP regulation system, baroreflex, to control blood pressure.

The Rheos System includes a small pulse generator implanted under the collarbone; two thin lead wires that are implanted at the left and right carotid arteries and connecting to the pulse generator; and the Rheos Programmer System, an external device used by doctors to non-invasively regulate the activation energy from the generator to the lead wires.

The company said the system “electronically activates the baroreflex,” which sends signals to the brain suggesting a blood pressure increase. “The brain then acts to lower blood pressure by sending signals to various parts of the body to reduce blood pressure, including the blood vessels, heart and kidneys.”

Abstract results published recently in the Journal of Hypertension reported a significant decrease in BP with the Rheos at 12 months. One-year results from 13 patients showed a 39 mmHg average decrease in systolic BP and a 26 mmHg average decrease in diastolic blood pressure.

Citing receipt of the CE mark as “an important milestone for our company,” Nadim Yared, president/CEO of CVRx , said, “Currently, we are focused on advancing the Rheos Pivotal Trial in the U.S. Patient enrollment in the Rheos Pivotal Trial is under way, and we expect outcomes from this study to support our pre-market approval application to the FDA.”

CVRx received investigational device exemption approval from the FDA to begin the Rheos Pivotal Trial evaluating the safety/effectiveness of the Rheos. The trial is enrolling 300 patients at multiple clinical sites in the U.S. and Europe.

The company noted that hypertension affects about 65 million people in the U.S. alone. It is estimated to cause one in every eight deaths worldwide.

Collexis adds German development partner

Collexis Holdings (Columbia, South Carolina), a developer of high-definition search and discovery software, said it has acquired its long-time development partner, SyynX Solutions (Cologne, Germany), a private software company.

SyynX is focused on text mining-based applications for life science and healthcare. It has collaborated with Collexis on both technical and commercial levels for nearly a decade and said the transaction is designed to combine the respective strengths of the two companies.

Recently, the two organizations partnered to design next-generation in social networking, an online platform for the life sciences. They said the system of pre-populated expert profiles, coupled with the ability to analyze all associated professional connections within the network, allows scientists and researchers across multiple organizations to share data and collaborate in new ways.

SyynX software applications, based on the company’s Fingerprint technology, are a tools employed by researchers at organizations such as Johns Hopkins University, the Mayo Clinic, the Dana Farber Cancer Institute and the National Institutes of Health.

“The SyynX software component is an ideal strategic complement to our existing capabilities as the market leader in high-definition search and discovery solutions,” said Collexis CEO Bill Kirkland. “Our offerings address a growing market trend, as scientists are increasingly recognizing the essential role that informatics, database and workflow solutions play in more effectively managing research programs and driving higher productivity.

“We believe the acquisition of SyynX will position Collexis as a global leader in providing these solutions, and our value proposition to clients will be stronger as a result.”

“After working together with the Collexis team for several years, [our] team is more than excited about bringing the two companies together,” said SyynX CEO Christian Herzog, MD. “The Collexis Fingerprint core technology, combined with the applications built by SyynX, will provide a great advantage to existing customers, as well as future ones.”

Martin Schmidt, chief technology officer of SyynX, said the combination “will enhance the world of knowledge management, text and knowledge mining solutions, not limited to the life sciences market.” He said the potential of the combination “is perhaps most evident as we prepare to launch our unprecedented social networking and collaboration platform for the biomedical research community in early 2008. We believe that this platform will change the way research is done.”

Collexis has existing European operations in Geldermalsen, the Netherlands.

CE marking updated for ExAblate2000

InSightec (Haifa, Israel) said that the CE-marking for its ExAblate2000 for uterine fibroids has been changed to say that women planning future pregnancies should consult with their physicians before seeking treatment with the magnetic resonance-guided focused ultrasound surgery (MRgFUS) system.

The CE mark had previously stated that only women who had completed their families should seek treatment with the non-invasive system.

Globes, the Israeli business publication, said that, according to the company, the change was made based on accumulating data from studies demonstrating that women safely gave birth after undergoing MRgFUS treatment.

The ExAblate system originally received the CE mark for uterine fibroids in 2002.

ExAblate is an outpatient procedure and patients return home the same day and to work within one to two days.

The ExAblate2000 combines MRI to visualize tissues in the body, plan the treatment and monitor in real time treatment outcome; and high-intensity focused ultrasound to thermally ablate uterine fibroid tissue. MR thermal feedback allows the physician to control and adjust the treatment in real time to ensure that the planned treatment outcome is achieved and surrounding tissue is spared.