CD&Ds

The past two years haven't boded well for drug-eluting stents (DES). Continued debate over the safety of the devices has been well-documented and has made headlines regularly in Cardiovascular Devices & Drugs and Medical Device Daily. But Cordis (Miami Lakes, Florida) a Johnson & Johnson (New Brunswick, New Jersey) company, is hedging its bets on the Nevo sirolimus-eluting coronary stent in a global head-to-head trial that will compare it to the Xience V everolimus-eluting coronary stent from Abbott (Abbott Park, Illinois)

The company apparently has so much faith in the Nevo and the positive results of the upcoming NEVO II trial that it has reported it will stop production of the Cypher Elite, which 700 patients in the U.S. have been implanted with and are currently enrolled in a clinical trial for the product, which will end in five years.

To make it even more apparent on how much Cordis seems to be backing the device and distancing itself from past models, the company has come up with the slogan, "Transform your thinking about DES."

"We believe Nevo is a significant step forward in stent technology," said Rogers, MD, company CSO and global head of R&D. "It marks a continuation of the Cordis tradition of innovation that began with our introductions of the first bare-metal stent and the first drug-eluting stent."

The NEVO II trial will be a randomized, non-inferiority trial of nearly 2,000 patients with coronary artery disease. Results from the trial will be used to provide long-term data in support of a pre-market approval application with the FDA. The company said it plans to meet soon with regulatory authorities to soon finalize this trial.

Nevo differs from other drug-eluting stents because it uses a reservoir (RES) technology, which J&J was able to acquire when it purchased Conor Medsystems for $1.4 billion two years ago.

Also unlike other drug-eluting stents, the company has made claims that stents developed with RES technology will not need to be surface-coated. Instead, each stent will have hundreds of small holes or reservoirs in the stent struts, loaded with a bioresorbable drug-polymer matrix. Over time, the drug polymer matrix is reabsorbed with no polymer left behind.

The design also allows drug delivery from a stent with a surface that is 75% bare metal upon insertion and becomes fully bare metal upon drug delivery and polymer bioresorption in three months.

Nevo does share some similarities with the Cypher, in that it will use the same drug, sirolimus, which has now been used in more than 3 million people.

A possible timeline for the device's regulatory approval shows the company pushing for the European CE mark by the end of this year, suggesting a potential launch for the device in 2010. Cordis also said it plans to file for U.S. approval in late 2011.

If proven to be successful, the stent could counter a study that ran in the New England Journal of Medicine, which compared coronary-artery bypass graft surgery and drug-luting stent procedures. The study evaluated Boston Scientific's (Natick, Massachusetts) Syntax and showed that those who underwent CABG have better results than those who have stent procedures.

It can scarcely be considered a secret that stenting procedures (drug-eluting stents in particular) have come under fire in the past few years. It all began right about the time Swedish doctors openly questioned the efficacy of DES and said that such procedures have a higher rate of death at the 2006 European Society of Cardiology (ESC; Sophia Antipolis, France) conference.

The reports at the time indicated DES devices may increase the risk of potentially fatal clots in the form of late thrombosis. As a result, the worldwide use of DES went into a sharp decline, with sales going from $5.1 billion in 2005 to $3.9 billion in 2007, according to the Thomson Reuters (New York) agency, Research Markets.

"We continue to be very enthusiastic about Nevo and believe it represents the most significant advance in the drug-eluting stent market since we launched the Cypher stent," Campbell said. "We also understand that in a rapidly evolving competitive and regulatory environment, it is incumbent on companies to show how a new product compares to a more recently approved product in the category, which is what we are doing with this new trial."

Elsewhere in the product pipeline:

• Cardiac Science (Bothell, Washington) said that it completed certification for its HeartCentrix ECG connectivity software with Sage Intergy EHR electronic health records system. Sage is a provider of computer-based practice management and electronic medical record (EMR) systems for medical group practices and healthcare systems. The company says that its software is designed to communicate seamlessly with EMR software, and it helps streamline workflow in multiple healthcare environments. HeartCentrix – which enables seamless data transfer from Burdick and Quinton brand electrocardiograph (EKG) devices, cardiac stress, and Holter monitoring devices to physician EMR software – can be installed with a new Sage Intergy EHR implementation or into an existing Intergy system.

• Digirad (Poway, California), a developer of medical diagnostic imaging products, reported that it has received 510(k) clearance from the FDA to market its Cardius X-ACT imaging system. Cardius X-ACT is a rapid cardiac SPECT/VCT imaging system that features a low-dose volume-computed tomography (VCT) attenuation correction system that significantly reduces artifacts in the images caused by overlying tissues increasing interpretive ease and accuracy. The X-ACT approach takes advantage of the 24 inch-wide detector array, eliminating truncation and generating what Digirad terms "high-precision transmission maps, improving the overall quality of SPECT studies." The company said the X-ACT attenuation correction system "offers high accuracy, fast acquisition, low dose (5 uSv per study) and superb reliability." The system's high-speed, triple-head, solid-state design — combined with nSPEED software — allows the combined cardiac SPECT emission and transmission acquisitions to be performed in as little as five minutes. Digiurad said the Cardius X-ACT system "increases diagnostic confidence in nuclear cardiology and raises the standard in the industry for overall SPECT system performance."

• GE Healthcare (Waukesha, Wisconsin) presented results at the annual American College of Cardiology meeting from the ADMIRE-HF study concerning the molecular imaging agent AdreView (Iobenguane I 123 injection) in heart failure patients at a higher risk for cardiac death, disease progression, or cardiac arrhythmias. AdreView, in conjunction with myocardial scintigraphy, was studied for its ability to evaluate the sympathetic nerves of the heart at the cellular level. Arnold Jacobson, MD, PhD, head, Cardiac Center of Excellence for GE Healthcare and lead investigator of the study, said that the data suggest that AdreView "may make it possible to assess the nerves of the heart, which cannot be done using tests such as echocardiograms and X-rays."

• Harvest Technologies (Plymouth, Massachusetts) reported positive interim results from the first 30 patients in the clinical trial of patients suffering with non-reconstructable critical limb ischemia due to advanced thromboangitis obliterans, commonly referred to as Buerger's Disease. The study tests Harvest's SmartPReP System, a point-of-care device for concentrating a patient's own (autologous) bone marrow stem cells in approximately 15 minutes. The interim evaluation conducted at 12 weeks showed convincing evidence that the treatment had significant clinical effect, Harvest said. The most important finding was that 87.5% of patients were able to save their legs. Quality of Life assessment (Rand-36 questionnaire) and individual perception of pain showed statistically significant improvement.

• Lantheus Medical Imaging (North Ballerica, Massachusetts) reported Phase I data on the safety and tolerability of BMS747158, its novel fluorine 18-labeled Positron Emission Tomography (PET) tracer for myocardial perfusion imaging in subjects under rest and stress conditions. The poster presentation on the results was made at this year's ACC scientific session. The data indicated that BMS747158 is well-tolerated and demonstrates radiation dosimetry that is comparable to or less than that of other PET agents and high myocardial uptake at rest that significantly increases with pharmacologically induced stress and a ratio of myocardial to background radioactivity favorable, and improved over time. The company said the findings "suggest" that BMS747158 has strong potential as a myocardial perfusion PET imaging agent for patients both at rest and under stress.

• Molecular Insight Pharmaceuticals (Cambridge, Massachusetts) reported positive detailed data on its Phase II trial (BP-23) for Zemiva. In this trial, the combination of Zemiva imaging with initial clinical information resulted in improved sensitivity (85%) compared to the sensitivity of the initial clinical diagnosis alone (52.2%), while maintaining specificity. Zemiva is a molecular imaging radiopharmaceutical to detect cardiac ischemia.

• NMT Medical (Boston) said it has received FDA approval for commercial sale of the company's StarFlex cardiac septal repair implant in the U.S. for patients with ventricular septal defects (VSD). The StarFlex implant can be placed in the heart to close the VSD using a catheter during a minimally invasive procedure, avoiding the need for the alternative treatment of open-heart surgery, which is considered a high-risk, invasive procedure. VSD is an opening between the right and left ventricle in the lower chambers of the heart and is the most common type of congenital heart defect. When there is a large opening between these ventricles, a large amount of oxygen-rich (red) blood from the heart's left side is forced through the defect into the right side. It is then pumped back to the lungs, even though it has already been filtered and refreshed with oxygen. This is inefficient, because oxygenated blood displaces blood that needs oxygen, which means the heart must pump more blood and may enlarge from the added work.

• St. Jude Medical (St. Paul, Minnesota) and GE Healthcare reported the worldwide commercial launch of the first fully integrated wireless solution for the measurement of Fractional Flow Reserve (FFR). The new FFR solution, integrated into existing cathlab infrastructure, will enable physicians and cathlab staff immediate access to FFR measurement without time consuming setup. The solution is based on the PressureWire Aeris technology and an FFR upgrade package available for the XT and XTi system configurations of GE's Mac-Lab hemodynamic recording system, a system used to record and display physiological parameters in the coronary cathlab. PressureWire Aeris was developed and marketed by Radi Medical Systems (Uppsala, Sweden), was acquired last December by St. Jude and now part of the company's Cardiovascular Division.

• SunTech Medical (Morrisville, North Carolina) reported the newest release of AccuWin Pro v3 ambulatory blood pressure monitoring (ABPM) software. AccuWin Pro v3 software supports SunTech's Oscar 2 ambulatory blood pressure monitor. The release offers various upgrades including new compatibility features for Windows Vista and integrated USB communications. The software also includes new features to assist with the process of analyzing and reporting on ABPM procedures such as time-slice period highlighting, medications memory auto-fill, and pre-programmed thresholds incorporating ESH and JNC7/ AHA recognized standards.

• At one point Symphony Medical (Laguna Hills, California) had plans to inject stem cells into the heart as a therapy to cardiac abnormalities. The plan was daunting, but at the time seemed ideal. However, placement of a biopolymer on the heart's left ventricle proved to not only be more effective, but also less cumbersome than using stem cells. The result of the switch was a therapy that promised results within hours of placement."We basically scrapped using [stem] cells," CEO Ray Cohen said. "The placement of this biopolymer gave us an immediate response. It took us literally hours to see a change in the heart's functionality." The biopolymer is called the Algisyl-LVR and the company will sponsor a clinical study of the treatment at four centers in Europe including the German Heart Center (Munich, Germany), where the first procedure was performed, and also is seeking an Investigational Device Exemption from FDA in order to conduct a follow-on U.S. study. The clinical study in Europe is to involve up to 18 patients and will wrap up in a matter of months, Cohen said. "Our first human subject was treated with the polymer and it was successful, there were no adverse events."

• Vasomedical (Westbury, New York) said it has received FDA clearance to market Vasomedical-BIOX 1305 ECG Holter Monitor and CB Series Ambulatory ECG Analysis Software. The Vasomedical-BIOX 1305 Holter Monitor is the latest addition to Vasomedical's product line. The Model 1305, which has already received CE Marking certification to market in the EU countries, is a compact, lightweight, 3-channel ECG Holter monitor designed for monitoring a patient's cardiac rhythm for 24 to 72 hours and recording ECG on a standard SD memory card. It features a high signal sampling rate and high resolution digital recording for comprehensive data analysis. The data recorded on the 1305 monitor is utilized in the early detection of cardiac abnormalities such as ischemia and arrhythmia.