CD&D and Staff Reports

ITGI Medical (Or Akiva, Israel) reported that its second heterologous tissue-covered stent, AneuGraft, has received CE-mark approval. AneuGraft is a stent completely covered with a heterologous tissue, designed to set a barrier between the coronary blood vessel wall and its lumen. It is intended for use in tortuous vessels.

"[The] AneuGraft Pericardium Covered Stent (PCS) is especially suitable for patients with tortuous vessels where other covered stents may not be adequate for use due to limitations resulting from tortuous anatomy," said CEO Efri Argaman.

The company said receipt of the CE-mark approval for the AneuGraft stent would enable it to provide "a wide range of coronary interventional solutions for all those situations that need to set a barrier between the vessel wall and its lumen, despite the anatomical limitations."

The stent is mounted on a delivery system designed to improve navigability of the stent in tortuous vessels.

Second in a series of heterologous tissue-covered stents under development by ITGI Medical, AneuGraft PCS is indicated for treatment of bypass stenosis, aneurysms and for emergency situations such as perforations in tortuous vessels.

Nicast gets CE mark for AVflo graft

Nicast (Lod, Israel), a developer of medical devices made from its electrospinning technology, reported the receipt of the CE mark for its flagship product, the AVflo artificial vascular graft.

The device is intended to help end-stage renal failure patients who must undergo hemodialysis treatment three or more times a week. AVflo enables hemodialysis to continue without further disturbance to the veins and arteries in the patient's arms already severely damaged by the habitual needle punctures required by the treatment.

The company said AVflo is the first vascular access graft to apply what it termed "the many beneficial properties of electrospun nanofabric."

Its self-sealing, non-woven, synthetic fiber structure provides excellent primary and secondary patency (unobstructed blood flow); allows for dialysis within 24 to 48 hours after implantation; and self-seals within less than five minutes following the withdrawal of the dialysis needles.

Nicast said AVflo is simple to implant and to suture to blood vessels; the needle punctures and suture holes do not bleed. "AVflo is strong enough to withstand the pressure of blood flow, yet thin enough for blood flow to be easily felt through it," the company said in a statement.

Mandika Wijeyaratne, MD, head of vascular surgery at Colombo University Medical School and principal investigator of the AVflo clinical study in Sri Lanka, said, "The AVflo graft tolerates punctures, holds sutures very well and does not tear or cut through in the process. Suture needles puncture and drive through the graft wall with greater ease and less force compared with existing clinically approved devices. Needle withdrawal and repositioning as in the case of an inappropriate puncture does not leave behind a hole in the graft that would bleed. The graft and vessel wall apposition is achieved very easily and is snug and secure."

Nicast said it has "excellent control of the properties of electrospun nanofabric," adding that it is "able to customize products to include the numerous special properties unique to this technology."

The company said this means the potential for "a long line of superior medical devices to be used in the treatment of many indications and consequently a better quality of care."

"What is . . . inspiring about today's development is that it puts Nicast on the radar as a company to watch," said Dr. Jacob Dagan, chairman of the board. "The company has gone through a remarkable turnaround in the last two years, one that has revitalized and given new direction to what is a venture rich area with unlimited product possibilities."

He added, "In the next two years the company plans to launch AVflo in the CE markets, conduct a multi-center post-marketing study of the same in Europe as well as finish the development and gain regulatory approval for the company's second product, the NovaMesh ventral hernias patch."

Dagan said Nicast is seeking an investment of $5 million at the beginning of 2009 and a second financing of $5 million at the end of 2009, with the proceeds from those financings to be used to execute its two-year development plan.

TriReme gets CE mark for Antares stent

TriReme Medical (TRM; Pleasanton, California) reported receiving the CE mark for its Antares Coronary Stent System, a main -vessel stent system designed for use at or near coronary bifurcations.

Representing "the next generation in bifurcation stenting," the Antares system has potential use in 25% of the 2.2 million angioplasty procedures performed annually worldwide, the company said.

"This significant milestone … allows commercialization of our Antares stent system in Europe," said Eitan Konstantino, PhD, president/CEO of TRM. "We believe that the Antares … represents a breakthrough in the treatment of patients suffering from coronary artery disease at or near bifurcations."

Professor Carlo Di Mario, of Royal Brompton Hospital (London), said, "I like the Antares system concept. … [It] is designed to fit all classes of bifurcation lesions, irrespective of the size and angulation of the side-branch. The operator does not need to commit to a pre-determined side branch treatment and has the flexibility to do what is right for the patient."

The company noted that lesions at or near side branches in the coronary tree pose multiple challenges to interventional cardiologists.

"Combining a low-profile stent with a proprietary delivery system, the Antares system provides a unique set of solutions to the challenges of bifurcation stenting," it said. "It can be delivered and deployed in a single step while maintaining access to the side branch and scaffolding the ostium, or the origin of the side branch. As a result, the cardiologist has greater flexibility of treatment options, with the freedom to deploy a second stent in the side branch when additional support is necessary."

Alexandre Abizaid, MD, PhD, chief of coronary interventions at the Institute Dante Pazzanese of Cardiology (Sao Paulo, Brazil), said that the Antares stent system "is an elegant solution to treat bifurcation lesions that is focused on the main vessel. It increases operators' confidence by providing continuous side-branch access throughout the procedure."

TRM is privately held and backed by Three Arch Partners and Adams Street Partners.

Finnish hospital implements Zoll pump

Zoll Medical (Chelmsford, Massachusetts), a maker of resuscitation devices and related software solutions, said that Kuopio University Hospital (KUH), one of the largest hospitals in Finland, has installed the company's AutoPulse Non-invasive Cardiac Support Pump in its intensive care department. Zoll said that KUH is the first hospital in Finland to establish protocols for using the AutoPulse.

Jouni Kurola, MD, of the department of anesthesiology and intensive care at the 800-bed hospital, recommended the implementation following a successful evaluation of an AutoPulse provided to the hospital by Zoll.

"It is remarkable to see how fast our nursing staff adopted the AutoPulse system in our intensive care unit," he said. "The AutoPulse gives us the opportunity to provide the best possible care for sudden cardiac arrest victims. Our colleagues in interventional cardiology have learned from our successes and now use the device as well."

AutoPulse is an automated, portable device with what Zoll terms "an easy-to-use, load-distributing LifeBand that squeezes a wider area of the chest in a consistent, uninterrupted 'hands-free' manner, improving blood flow to the heart and brain during cardiac arrest. Additionally, it offers the benefit of freeing up rescuers to focus on other life-saving interventions."

"We're pleased that Kuopio University hospital, one of the largest and most respected in Finland, has recognized the potential the AutoPulse has to provide care for SCA victims in their intensive care department and cath lab by delivering consistent, high-quality chest compressions," said Richard Packer, CEO and chairman of Zoll.

To date, about 3,000 AutoPulse units have been deployed in hospitals and emergency services worldwide.

Sudden cardiac arrest claims more than 1 million lives each year worldwide, Zoll said. It is the leading cause of unexpected death in the world and strikes without warning. Currently, only about 5% of victims survive.

Zoll sells its products in more than 140 countries, with direct operations, distributor networks and business partners throughout the U.S., Canada, Latin America, Europe, the Middle East and Africa, Asia, and Australia.

Czech Republic office for Averion

Averion International (Southborough, Massachusetts), an international clinical research organization (CRO) specializing in oncology, cardiovascular diseases and medical devices, said it has further strengthened its European operations by opening an office in the Czech Republic.

"Averion continues to expand its European footprint to meet the needs of our clients," said CEO Markus Weissbach, MD, PhD. "In the heart of Central Eastern Europe, the Czech Republic offers a strong clinical trial environment with large patient populations and well qualified investigators in a broad range of indications. These critical factors are top priorities for our clients and they are vital to the successful conduct of international trials."

The Czech Republic office, located in Prague, is led by Dr. Libor Hubacek, country manager for Averion, which he joins with more than 10 years of experience in monitoring, submissions and management of clinical trials in the Czech Republic, with particular expertise in arterial hypertension, oncology, renal impairment, pulmonology, urinary tract infection, atherosclerosis, diabetes mellitus, cystic fibrosis and others.

The new office is staffed with experienced clinical research associates and clinical trial assistants, with additional staff hiring anticipated in the coming months.

Averion's European operations are headquartered in Basel, Switzerland. It has additional U.S. offices in California, Maryland and New York; and international offices in France, the Netherlands, the UK, Poland, Russia, Israel, Germany, Austria, Ukraine and the Czech Republic, along with operation centers in Slovakia and Hungary and research partnerships in India, Asia and South America.

Lotus Valve System in second study phase

Sadra Medical (Campbell, California) reported the enrollment and treatment of four new patients in the second phase of the European feasibility study of the Sadra Lotus Valve System.

The system is designed to enable physicians to replace a diseased aortic valve using a less-invasive approach, navigating the valve through the patient's arteries using a catheter, thus eliminating the need for an open-chest surgical procedure.

Each one of the four patients presented with severe aortic stenosis and none was a candidate for surgical therapy. All were treated by Drs. Eberhard Grube and Ralf M ller at Heart Center Siegburg (Siegburg, Germany).

The surgeons said that the Lotus Valve deployment time averaged 16 minutes and that post-implantation valve function was good, with no perivalvular leakage observed.

"The percutaneous aortic valve replacement [PAVR] procedure using the Sadra Lotus Valve is enhanced by the ease of placement and the ability to safely reposition or retrieve the valve," said Grube, principal investigator for the Sadra Lotus Valve European feasibility study. "Based upon the one-year follow-up from the first patient and my experience involved in treating this latest set of patients, I am very encouraged about the Lotus Valve's potential to improve the PAVR procedure."