A CDU

The Cardiac Rhythm Management group of Sorin Group (Milan, Italy) reported the initiation of the Optimal Antitachycardia Therapy in ICD Patients without Pacing Indication (OPTION) clinical study in Europe. The study objective is to demonstrate that implantable dual-chamber cardioverter defibrillators (ICDs) have greater efficacy than single-chamber ICDs in reducing inappropriate shock delivery and have the same efficacy in reducing all-cause patient mortality and hospitalizations due to cardiovascular events.

OPTION, multi-center and two-armed, aims to demonstrate that patients implanted with dual-chamber ICDs incorporating features such as optimal dual-chamber arrhythmia detection, a pacing mode that minimizes ventricular pacing and a slow ventricular tachycardia zone, have better outcomes in terms of inappropriate shock delivery, patient mortality and hospitalizations than patients with single-chamber devices.

The first patients enrolled in the OPTION in Germany, Portugal and Italy were implanted with Sorin's Ovatio dual-chamber ICDs featuring the PARAD+ arrhythmia detection algorithm, AAIsafeR mode that limits ventricular pacing and a slow ventricular tachyarrhythmia (VT) zone. Patients included in the study are randomized to either single-chamber ICD therapy following standard clinical practice with an active monitoring zone to allow ventricular arrhythmia documentation, or to dual-chamber detection and therapy in the slow VT zone with AAIsafeR switched on.

"We are confident that OPTION will significantly help us assess whether dual-chamber ICD therapy gives clinical benefit to patients without a pacing indication," said Christof Kolb, MD, of Deutsches Herzzentrum (Munich, Germany), the principal study investigator. "Ovatio DR innovative features and the design of the trial will enable us to investigate the impact of ICD therapy on the full range of ventricular tachyarrhythmias, including slow VTs, in combination with pacing backup in patients with impaired left ventricular function to avoid unnecessary ventricular stimulation. We also expect that the results of OPTION will help us in better selecting ICD candidates."

Another objective of the study is to determine how to best identify patients who could benefit from ICD therapy using Sorin Group's "T-variability" risk stratification method, a noninvasive Holter-based test that analyzes micro-volt variations that are linked to the development of life-threatening tachyarrhythmias.

The OPTION study will enroll 450 patients in Europe, Canada and the U.S. Interim results will be published every 12 months. A follow-up phase of 27 months is scheduled after enrollment to allow monitoring of the development of atrial fibrillation and congestive heart failure.

Abiomed, Medix Japan in distribution pact

Abiomed (Danvers, Massachusetts) reported a five-year distribution agreement with Medix Japan (Tokyo), a company that distributes cardiac assist devices in that country. Building on its eight-year relationship with Abiomed, Medix will initiate clinical trials in Japan during Abiomed's FY08. The agreement provides for distribution of Abiomed's AB5000 and Impella products and includes a minimum purchase of Impella products of $11 million within the first 18 months following Impella regulatory approvals in Japan. The balance of the purchase commitment for Abiomed's other products begins in Abiomed's 1Q08.

Yasu Matsuoka, president of Medix, said. "We believe that this technology will have a profound effect on patient care and are totally committed to working with our government officials and the Abiomed team to bring these products to the Japanese market as rapidly as possible."

Michael Minogue, president/CEO of Abiomed, said, "Japan represents a sizeable market for our recovery technologies with a population of approximately 127 million, 600 open heart hospitals and 1,800 catheterization labs. Heart recovery is one of the main priorities in Japan and their physicians often provide some of the most elaborate evidence-based scientific publications in the world. We have found a valuable partner with Medix and are excited for the future," Minogue said.

Abiomed makes the AB5000 Circulatory Support System and the BVS 5000 Biventricular Support System for the temporary support of all patients with failing but potentially recoverable hearts. In Europe, Abiomed offers the minimally invasive Impella Circulatory Support System under CE mark approval. The Impella 5.0 and 2.5 are investigational devices limited to investigational use in the U.S.

Lombard wins supplemental IDE

Lombard Medical Technologies (Oxfordshire, UK) reported receiving conditional FDA approval for its supplemental Investigational Device Exemption (IDE-S) for its pivotal U.S. clinical trial of the Aorfix endovascular stent graft in the treatment of abdominal aortic aneurysms (AAAs). The company said it originally envisioned the trial as having two endovascular arms, one for aneurysms with neck angulations of up to 60 degrees (low- or moderate-angle cases) and one for aneurysms with neck angulations of between 60 degrees and 90 degrees (high-angle cases), as well as an open surgery control arm. But the FDA has provisionally accepted arguments in the supplemental IDE submission to have a single endovascular arm in which each center could recruit patients with any neck angle up to 90 degrees following an initial recruitment of five low/moderate angle cases.

Lombard said this change in trial design allows a reduction of the number of cases to be performed from 385 to 210, shortening the time required to recruit patients into the trial. It said that since the centers cannot enroll high-angle cases (for which there is no licensed endovascular treatment option) until they have completed five low- or moderate-angle cases, there now is an incentive for them to recruit low- or moderate-angle cases quickly.

The IDE-S also allows Lombard Medical to use the improved version of Aorfix launched in Europe in April in the trials. The company said that product is "much preferred" by physicians due to its greater flexibility, longer shelf life and increased visibility under X-ray.

Alistair Taylor, executive chairman of Lombard, said that the changes "will benefit from earlier access, albeit in a trial, to a device that can be used in high angle cases for which there is currently no approved endovascular treatment option in the U.S. We believe that this, along with access to our improved device, will have a significant impact on recruitment rates resulting in Aorfix entering the important U.S. market earlier than previously anticipated."

Lombard's latest project is to develop a coated stent that encourages local self-repair of blood vessels. This involves attaching stem cell-derived endovascular cells to Lombard's programmable polymer coating on the stent surface, which will allow the human body to promote controlled vascular repair and heal the damaged coronary artery vessel wall itself.

Elbit unit wins FDA OK for StemEx study

Elbit Medical Imaging (Tel Aviv, Israel) reported that its subsidiary, Gamida Cell, in which EMI holds a 25% stake, has reached an agreement with the FDA for a special protocol assessment (SPA) for the design of a pivotal registration study of StemEx for the treatment of hematological malignancies. Gamida Cell is developing StemEx in a joint venture with Teva Pharmaceutical Industries (Jerusalem).

StemEx is composed of ex vivo expanded cord blood stem/progenitor cells which are transplanted in combination with non-expanded cells from the same cord blood unit. Stem cell transplantation is a treatment for high-risk hematological malignancies. It is thought to provide an alternative source of stem cells for these patients by enabling the use of cord blood for transplantation.

StemEx was granted an FDA Orphan Drug designation in March 2005.

Gamida Cell reports a product in "advanced" pre-clinical development for the treatment of heart disease.

SunTech opens Hong Kong office

SunTech Medical (Research Triangle Park, North Carolina), a developer of motion-tolerant, non-invasive blood pressure monitoring technology, has opened a new sales and service office in the Bank of China Tower, Hong Kong. Anthony Nixon, director of Asia/Pacific sales, has relocated from the company's office in Oxford, UK, to the Hong Kong branch.

Nixon said the company's presence in Hong Kong "will enhance our ability to provide service and support to customers throughout East Asia, Southeast Asia and the Indian subcontinent."

SunTech offers products for 24-hour ambulatory blood pressure monitoring, cardiac stress BP monitoring, customizable OEM BP modules and blood pressure cuffs. SunTech is a subsidiary of SunTech Medical Group (Oxford, UK), a holding company focused on medical diagnostics.

Angiotech seeks CE mark for Vascular Wrap

Angiotech Pharmaceuticals (Vancouver, British Columbia), a specialty medical device and pharmaceutical company, reported that it has submitted an application for a CE Mark for its Vascular Wrap paclitaxel-eluting mesh/ePTFE vascular graft combination product on the strength of the results from its European first-in-man study. William Hunter, MD, president/CEO of Angiotech, said, "With the acquisition of the vascular graft product line from Edwards Lifesciences [Irvine, California] last year, as well as the acquisition this year of American Medical Instruments [New Bedford, Massachusetts], we believe we are well positioned to capitalize on and economically benefit from this potentially category-defining product.

"We believe the market potential for our Vascular Wrap product could be significant. With the results from the two-year European study and our upcoming trials in AV Access in the UK and U.S., we believe that we have the potential to build a significant vascular franchise."

The two-year trial produced data indicating that treatment with the Vascular Wrap reduced the overall incidence of leg amputation and prolonged limb retention time in patients suffering from late stage peripheral arterial disease who underwent bypass surgery. For the patients that required an amputation during the study period, the mean interval to amputation for patients treated with the Vascular Wrap was 156 days — more than double the mean interval to amputation for the control, which was 76 days, and it appeared to be well tolerated, with no adverse events related to the use of the product.

The Vascular Wrap consists of both the ePTFE graft and the Vascular Wrap paclitaxel-eluting mesh. The Vascular Wrap component is a biodegradable mesh implant incorporating Angiotech's paclitaxel technology in a biomaterial with the goal of mitigating scar formation caused by abnormal blood flow thereby potentially enhancing graft patency rates in AV-access patients as well as in peripheral bypass procedures.

The Vascular Wrap in combination with an ePTFE graft was compared to a control group of patients that received standard of care — an ePTFE graft alone.

Some key findings:

• Adverse events (AE) leading to death occurred in a lower percentage of treated subjects (11%, 8/71), than in controls (18%, 7/38).
• The incidences of adverse events and serious adverse events were comparable in treated (graft with Vascular Wrap) and control (graft alone) groups.
• No adverse events were considered by the investigators to be related to the use of the Vascular Wrap.
• Overall, the action taken to resolve AEs was similar for the two groups, and the outcomes were comparable.
• When comparing the treatment arm relative to the control, the Vascular Wrap maintained the mean diameter of the distal anastomosis during the 24 month trial compared to a decrease in mean diameter in the control arm. This reached statistical significance (p = 0.0333).

The single-blind study enrolled a total of 109 patients at nine clinical centers in Europe as well as the Dutch Antilles and randomized patients with peripheral vascular disease in a 2:1 fashion. The treatment arm enrolled patients with a synthetic bypass graft plus the Vascular Wrap paclitaxel-eluting mesh, and the control arm enrolled patients with a synthetic bypass graft alone.

The success of grafting to restore blood flow depends on inflow and outflow of the graft. The trial results show trends that suggest that the use of the Vascular Wrap in these procedures may increase the success rates of vascular graft surgery.

TopSpin Medical raises $11 million

TopSpin Medical (Tel Aviv, Israel) reported raising $11 million in convertible bonds from institutional investors on the Tel Aviv stock exchange.

TopSpin, which has developed a technology platform designed to enable MRI to be conducted with no external magnets, says that the ability to perform high-resolution local MRI with no external magnets is "a breakthrough in medical imaging as it enables the extension of MRI technology to a wide range of applications, in which conventional MRI cannot get to the required resolution or is simply too bulky and expensive."

The primary application is high-resolution imaging of coronary artery walls during cardiac catheterization by a single-use, IntraVascular MRI (IVMRI) catheter. The IVMRI catheter has demonstrated accurate characterization of the lipid composition of atherosclerotic plaque — the most important factor in determining plaque instability.

TopSpin has successfully completed its first-in-man (FIM) clinical trial, which, the company anticipates, would allow it to obtain a CE mark for the IVMRI system by the end of 2006. An additional clinical study is now ongoing in more than 10 centers in Europe, Israel and the U.S. To date, about 100 patients have been enrolled in TopSpin's studies with good safety and performance results. The company said it plans to use the data to obtain FDA market clearance, which is expected by mid-2007.

"The $11 million raised will allow us to launch our IVMRI catheter in Europe and in the U.S., while continuing to invest in an extensive post-marketing clinical program that would help build our market," said Erez Golan, TopSpin's president/CEO.

Enrollment completed in LeMaitre trial

LeMaitre Vascular (Burlington, Massachusetts) reported the enrollment of the 30th and final patient in the EndoFit Thoracic Stent Graft Clinical Study in that country.

The company said the objective of the study is to obtain data in support of approval of the EndoFit Thoracic Stent Graft from the Chinese State FDA (SFDA). Completion of patient enrollment marks the start of a six-month follow-up and observation period.

George LeMaitre, president/CEO and chairman, called the enrollment figure "a key regulatory milestone in this rapidly emerging endovascular device market."

The EndoFit Thoracic Stent Graft is used to treat aortic aneurysms. The device's encapsulated design prevents its stents from contacting the bloodstream or the vessel wall, thus allowing a wider range of stent graft sizes, including tapered and custom grafts, to fit a wider range of patient anatomies than many competing products.

Dr. Weiguo Fu, director of the endovascular department at China Fudan University Zhongshan Hospital, said, "The radial force of the proximal end of the EndoFit Thoracic Stent Graft seems superior, as we have not seen any migration post-implantation."

The EndoFit Thoracic Stent Graft is sold in the European Union and a small number of other foreign jurisdictions.