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Boston Scientific (Natick, Massachusetts) last month reported the market launch and first implants of its Taxus Element Paclitaxel-Eluting coronary stent system in the European Union and other CE mark countries. The Taxus Element stent system is the company's third-generation drug-eluting stent (DES) technology and incorporates a platinum chromium alloy with an innovative stent design and an advanced catheter delivery system. It received CE mark approval in May, which included a specific indication for the treatment of diabetic patients.

Corrado Tamburino, MD, PhD, chair of the cardiology department at Ferrarotto Hospital (Catania, Italy) and Adrian Banning, MD, directorate chair of cardiac services at John Radcliffe Hospital (Oxford, UK), performed the first European implants.

“I have found the Taxus Element stent to offer performance advantages in flexibility, visibility and deliverability over prior-generation stents,“ Tamburino said. “The platinum chromium alloy and new stent design used in the Element platform, together with the proven Taxus drug and polymer, represent a significant advance in coronary stenting.“

Banning said the diabetic indication for the Taxus Element provides “an important benefit“ given that roughly one third of all patients presenting with coronary artery disease in Europe have diabetes.

“Diabetic patients with coronary artery disease often have poorer outcomes after revascularization procedures. The paclitaxel-based Taxus Element stent has a unique mechanism of action that helps inhibit restenosis in high-risk patients with diabetes,“ Banning said.

The Taxus Element is designed specifically for coronary stenting and leverages the performance advantages of the Element stent platform with a decade of clinical success from the Taxus program, Boston Scientific says. According to the company, the stent architecture and platinum chromium alloy combine to offer greater radial strength and flexibility. The stent architecture helps create consistent lesion coverage and drug distribution while improving deliverability, which is enhanced by an advanced catheter delivery system. The higher density alloy provides superior visibility and reduced recoil while permitting thinner struts compared to prior-generation stents, Boston Scientific said.

Fosun buys $30M of Chindex stock

Chindex International (Bethesda, Maryland) and Shanghai Fosun Pharmaceutical (Shanghai) said in June that they have entered into a strategic alliance to use respective strengths in China's medical industry. Additionally, Fosun will take a 25% stake in Chindex, buying $30 million of the company's stock.

Fosun Pharma and Chindex will form Chindex Medical, a joint venture focused on manufacturing and distributing medical devices in China. The venture would merge and operate Chindex's Medical Products division and certain of Fosun Pharma's medical device businesses in China. Fosun Pharma will own 51% and 49% by Chindex.

Fosun Pharma also agreed to purchase from Chindex up to 1,990,447 shares of Chindex common stock at $15 a share, which when aggregated with other Chindex shares owned by Fosun Pharma would gain Fosun Pharma up to 4,229,701 shares, representing a 25% ownership stake in Chindex, subject to certain stockholder limitations.

The stock sale is expected to raise an aggregate of about $30 million, the net proceeds of which are expected to be used, among other things, to continue expansion of the company's United Family Healthcare network. The sale of the shares of common stock would be completed in two closings, the first of which is expected to occur in the second quarter of the current fiscal year, subject to certain customary closing conditions, and would relate to about one-half of the shares to be purchased.

The closing of the balance of the shares would occur subject to the consummation of the joint venture as well as certain customary closing conditions. In connection with the transactions, until the occurrence of certain events, Fosun Pharma has agreed to certain voting and standstill limitations.

US HIFU acquires European rights for Sonoblate

US HIFU (Charlotte, North Carolina), a developer of minimally invasive high intensity focused ultrasound (HIFU) technologies and manufacturer of the Sonablate 500 (SB 500), reported the acquisition of certain Misonix (Farmingdale, New York) HIFU assets and European distribution rights. In addition, through its transaction with Misonix, US HIFU acquires the Sonatherm 600 medical device, a laparoscopic HIFU system used to ablate certain soft tissues.

The company said the acquisition of the Sonatherm 600 is a major step for US HIFU: it represents the company's first device with FDA clearance for commercialization in the U.S.

In consideration for the sale Misonix will receive up to about $5.8 million, paid out of an earn-out of 7% of gross revenues received by USHIFU related to the businesses being sold, up to the time we have received the first $3 million, and thereafter 5% of gross revenues up to the $5.8 million. Misonix will also be paid for its present inventory of new SB500 machines, inventory associated with manufacturing the SB500 and will be reimbursed for certain monies expended in connection with the HIFU Registry.

In addition to US HIFU's plans for clinical evaluation of the Sonatherm 600 in Europe and the U.S., its plans for growing the Sonablate HIFU technology in Europe include rolling out state-of-the-art SB 500 machines; infusing both capital and human resources to significantly increase access to Sonablate HIFU; expanding the base of European Sonablate users; and increasing the existing clinical data registry.

Sonablate HIFU for prostate cancer is a minimally invasive, targeted approach to treating the disease with precision-focused ultrasound energy that, when delivered, raises the temperature of the tissue in a matter of seconds, resulting in its destruction. The tissue throughout the prostate is ablated while structures outside the gland remain unharmed.

UK HIFU, one of US HIFU's subsidiaries, will conduct day-to-day European operations. The first European headquarters will be in the UK, with a satellite office in Berlin scheduled to open over the next three months. In collaboration with UK HIFU employees, US HIFU staff will launch and continue to conduct business operations in Europe to guarantee rapid proliferation of the technology and physician training.

Sonablate HIFU is under clinical investigation by the FDA in the U.S. but approved or authorized and commercially available in more than 30 other countries. Through International HIFU, one of US HIFU's subsidiaries, patients and physicians from the U.S. are traveling regularly for the procedure to locations where it is approved and available, such as Mexico, Bermuda, the Bahamas and Canada.

Study supports t-VNS for hard-to-treat epilepsies

An evaluation has revealed positive intermediate results for the first three months of clinical trial data for the treatment of therapy-resistant epilepsies with the world's first device using transcutaneous vagus nerve stimulation (t-VNS), from cerbomed (Erlangen, Germany).

According to the company, t-VNS proves its good safety profile and scores high on user-friendliness, and there are also preliminary indications of its effectiveness for the patients in the cMPsE01 pilot study.

The cMPsE01 pilot study is structured as an uncontrolled, single-center prospective pilot study with a verum group, carried out under the supervision of Hermann Stefan, MD, a professor at the epilepsy center of the University Hospital of Erlangen. The study includes 10 patients, for an expected therapy period of nine months, cerbomed said.

The primary aim of the trial is to prove the safety and feasibility, as well as the compliance of t-VNS. The study's secondary aim is the early determination of whether t-VNS has anticonvulsive effectiveness, that is, whether it reduces the frequency and duration of episodes in hard-to-treat epilepsies, the company said. A further goal is to gather information for planning the number of cases, as well as specific inclusion and exclusion criteria for the planned follow-up study, which will focus on the effectiveness of t-VNS therapy, cerbomed noted.

According to cerbomed, t-VNS uses the principle of invasive vagus nerve stimulation, which has been established as a method to treat therapy-resistant epilepsy, and is certified for use in North American and European markets. Until now, the only available product for VNS that is reimbursed by health insurance companies is a device which must be surgically implanted in the patient's neck, in the immediate vicinity of the vagus nerve, the company said. Taken together, the product and medical costs of invasive VNS are nearly $33,000 in the U.S.

According to cerbomed, it has developed technology that aims to make the transcutaneous application of VNS possible. This removes the need for an operation, thus eliminating the associated risks, costs and side effects, the company noted. This means a considerably more patient-friendly and economical treatment. The technology uses the fact that branches of the vagus nerve run immediately under the surface of the skin close to the ear, and are therefore suitable for stimulation through the skin, cerbomed said.

Correlogic's ovarian cancer test gets CE mark

Correlogic Systems (Germantown, Maryland) said that OvaCheck, its blood test for the detection of epithelial ovarian cancer, has fulfilled CE marking requirements, clearing the path for the test to be made available in Europe.

OvaCheck is a multivariate index assay that measures the relative ratios of eight proteins. It employs a bead-based multiplexed immunoassay platform and Correlogic's proprietary software system to return a result. According to Correlogic, the blood test will help physicians more accurately determine whether a pelvic mass is ovarian cancer, leading to earlier, appropriate treatment and fewer unnecessary surgeries.

Correlogic is currently in discussions with potential partners for distribution of OvaCheck in Europe.

Celera's KIF6 test for CHD gets CE mark

Celera (Alameda, California) has signed a declaration of conformity and applied the CE mark to a real-time PCR test for detection of a variant in the KIF6 gene, allowing the test to be marketed in the EU and other geographic areas that recognize the CE mark.

KIF6 encodes a kinesin, a member of a family of proteins involved in microtubule-mediated intracellular transport. Previous research has shown that a variant of the KIF6 gene is associated with up to a 55% increased risk of primary and recurrent coronary heart disease (CHD) events in the placebo arms of pravastatin clinical trials, and that this increased risk was significantly reduced with statin therapy.

Zimmer launches system for femur fractures

Zimmer Holdings (Warsaw, Indiana) has introduced the Zimmer Natural Nail Cephalomedullary Nail System to the European market. The Cephalomedullary Nail is designed to help address fractures of the femur, especially intertrochanteric and subtrochanteric fractures. The Cephalomedullary Nail features an anatomically contoured implant and intuitive instrumentation capable of addressing the needs of patients of all shapes and sizes.

Central to the design of the Cephalomedullary Nail is its anatomic shape which helps restore patients to their natural, pre-injury state. The nail provides fixation to help restore the natural shape of the femur, and features a small proximal section designed to minimize the amount of bone that must be removed for nail insertion. The nail features Zimmer's StabiliZe Technology and screw locations to help better link the nail to bone. Screws are placed throughout the implant to further secure it and maintain length and alignment during the healing process. A choice of short and long nails, as well as nails of different diameters and center-column-diaphyseal angles are available to best match the individual anatomy of the patient.

Medtronic's iPro2 glucose monitor gets CE mark

Medtronic (Minneapolis) has launched the iPro2 Professional CGM, a continuous glucose monitoring (CGM) system used by physicians to help improve diabetes management, in 49 countries around the world. This fourth-generation CGM system is designed for detecting high and low glucose fluctuations that can lead to dangerous health complications, which often go undetected with traditional A1C tests, a measurement of glucose control over a two-to-three-month period) and glucose meter measurements.

iPro2 Professional CGM includes a disposable glucose sensor and a small data recorder, which automatically record glucose information. The monitor is simple to start and significantly reduces the amount of clinical staff time needed to implement the therapy. There is no computer required for setup, patients do not interact with the device, and minimum patient training is required. Patients wear the small, lightweight and watertight device while going about their normal daily activities before returning it to their physicians' office for evaluation.

Once returned, glucose information stored in the device is easily uploaded using a docking station to new CareLink iPro software, a web-based platform that makes data from iPro2 Professional CGM easy to evaluate.

First center in Mexico uses Gore Occluder

W. L. Gore & Associates (Flagstaff, Arizona) reported in June that Instituto Nacional De Cardiologia (Mexico City) is the first hospital in the country to use the Gore Helex Septal Occluder for the transcatheter closure of an atrial septal defect (ASD). Department Chief, Carlos Zabal and Jose Garcia Montes of the Instituto Nacional de Cardiologia achieved the milestone procedure in March 2010.

Three separate and successful ASD closures were completed, making the hospital the first in Mexico to use the Gore Helex Septal Occluder.

An ASD is a congenital heart defect that affects thousands of patients every year. The Gore Helex Septal Occluder is a permanently implanted prosthesis and the first device of its kind to use ePTFE. Its unique ePTFE patch material is supported by a single wire nitinol frame that conforms to the patient's anatomy. According to Gore, the catheter-based delivery system allows for easier device deployment via standard femoral venous access.

HyperBranch wins CE mark for Adherus sealant

HyperBranch Medical Technology (Durham, North Carolina) has received a CE mark for Adherus spinal sealant, which is used in spinal surgeries where a water tight seal is required to prevent cerebrospinal fluid leakage from the dural repair. Prevention of cerebrospinal fluid leaks should benefit the patient in shorter hospital stays and fewer post-surgical complications such as reduced pain and fewer infections. Adherus also acts as an adhesion barrier, thereby simplifying subsequent surgeries should the need arise, the company said.

The single-use device is terminally sterilized and can be applied in both open and MIS procedures through either a 100 mm or 150 mm tip. The CE mark provides regulatory approval for the company to begin sales in Europe and other countries outside the U.S.

The Adherus products are synthetic hydrogels which polymerize in a moist field, flow optimally depending on the application, and are biodegradable as the tissue re-establishes itself. The biocompatible composition is stored at room temperature and is delivered through a custom applicator to meet the specific needs of the procedure.