Cordis (Miami Lakes, Florida), a subsidiary of Johnson & Johnson (New Brunswick, New Jersey) last month unveiled plans to develop what it called a “world-class global cardiac and vascular institute.” The institute is intended to provide physicians and other healthcare providers with educational and clinical resources to help advance the understanding and treatment of a broad range of cardiac and vascular conditions, including coronary artery disease and stroke. The company said the institute, to be called the Cordis Global Cardiac & Vascular Institute (CCVI), will also enhance knowledge concerning the management of congestive heart failure, adult cell therapy and advanced cardiac imaging, mapping and ablation. Currently more than 120 million people globally are treated for vascular conditions, Cordis said.

The CCVI will unite current and future training centers around the world, including facilities in China, Europe, Latin America, India, Japan, and the U.S., to encourage new technology and procedure development across vascular, cardiology and electrophysiology areas, Cordis said. The use of a multitude of portable simulators will continue to bring training directly to physicians and other health care providers and facilitate education outside of the designated facilities.

Chris Allman, a Cordis spokesman, said that “Prior to putting the institute under one unified umbrella, the individual businesses [of Cordis] were doing their own thing.” By pulling these all together “it will really make it much more comprehensive and easier for physicians,” he told Cardiovascular Device Update. “Ultimately, what we want to be is the premier resource for physician education and training.”

The company said that the multi-faceted CCVI will include global initiatives such as fellows programs, proctorships, professional training and education and the development and use of innovative technology to treat a range of cardiac and vascular conditions. In addition, CCVI will focus on building physician and healthcare provider expertise in emerging markets. “If you look at the institute as more than just bricks and mortar,” said Allman, “that’s where things like proctorships and fellowship programs and helping provide insight into potential new products and all those types of things [come into play].”

“As patient disease becomes more complex, there is a greater need for comprehensive training and education that allows physicians and other healthcare providers to stay abreast of the latest technologies and treatments,” said William O’Neill, MD, chairman of the department of cardiology at William Beaumont Hospital (Royal Oak, Michigan). “Cordis recognizes this and has taken a leadership role in forging partnerships that meet this need.”

To help guide the creation of the CCVI, Cordis said it will convene a group of international thought leaders from various fields – cardiology, endovascular medicine, neurovascular medicine, cardiac rhythm management and stroke – as well as international representatives of cardiac and vascular professional and patient organizations, to serve as technical and strategic advisors. The company said the first global summit of international leaders will take place during this year’s annual EuroPCR annual meeting mid-May in Paris.

A ‘universal’ ICD, pacemaker programmer

St. Jude Medical (St. Paul, Minnesota) has received FDA approval of what it calls a “universal” new programmer for its implantable defibrillators (ICDs) and pacemakers. The device, called the Merlin patient care system, is designed to help physicians more efficiently conduct tests, analyze therapeutic and diagnostic data, and program implanted devices for optimal patient care. Merlin supports both current and previous generation devices and represents what the company banners as a “significant market launch for St. Jude Medical and one of more than 20 new cardiac rhythm management products expected to be introduced this year.”

Kathleen Janasz, company spokesperson, emphasized that the system is “universal” only in the sense that it can be used for most St. Jude ICDs and pacemakers and is not designed to work with competitors’ devices. But she emphasized also that it was a large step forward for the company’s products. “This programmer really resets the bar for patient care systems, and it goes further than just the typical programmer in that it’s more efficient in how it conducts tests, how it analyzes data and how it supplies that data to the physician or the nurse who is conducting the tests and doing the follow-up visits,” Janasz told CDU. She added that the new programmer does these things “far faster than any previous versions that were available.”

Perhaps the most important critical new component of the Merlin, said Janasz, is its touch-screen system; which was designed based on conversations with clinicians to better understand what the typical patient follow-up visit entails. “After determining what it was they needed and how they wanted to proceed, we developed the workflow of this system to mimic that.” This means that as clinicians walk through a follow-up visit, “this screen intuitively moves through the visit in the same way.”

Janasz also noted that the Merlin, weighing in at about 24 pounds, represents a highly portable alternative to past programmers, particularly when considering that it “has more power,” pound for pound. “I’m not sure that there’s anything that is as powerful as this or as fast as this,” she said. The new system takes the patient information and puts it “quite literally at [clinicians’] fingertips,” she said.

Corautus terminates GENASIS trial

Corautus Genetics (Atlanta) last month called a halt to enrollment in its Genetic Angiogenic Stimulation Investigational Study (GENASIS) Phase IIb clinical trial, based on the recommendation of its independent data monitoring committee (DMC). The trial had enrolled patients with Class III or IV angina that are not suitable candidates for traditional revascularization procedures and had involved the injection of genes – specifically vascular endothelial growth factor-2 (VEGF-2) – into the heart to stimulate the formation of new blood vessels via a process known as therapeutic angiogenesis.

Trial termination follows enrollment suspension by the company on March 14 to investigate three recent serious adverse events that the company said it did not believe were associated with the biologic. The March 14 disclosure also prompted the company to cancel a planned public stock offering of 7.5 million shares at $3.85 a share. The offering had been slated for March 15. The DMC recommended that, based on available efficacy data, enrollment should be terminated under the current protocol since, the DMC said, it saw “very little chance for significant efficacy” as to the primary endpoint relative to the safety/risk signal it saw.

In a conference call, the company said it will continue to collect efficacy data until the last patient previously enrolled in the trial has been followed for six months. At that time, the company plans to lock the study database and perform unblinded endpoint analyses of VEGF-2 efficacy. Safety data will be followed for a period of 12 months from the date the last patient was enrolled.

At the time of the mid-March trial suspension, 295 patients had been enrolled in the trials, originally scheduled to enroll 404 patients at 30 centers in the U.S. In response to the company’s action, the FDA placed the trial on clinical hold, pending review by the DMC.

The therapy had been administered into the heart using Boston Scientific’s (Natick, Massachusetts) Stiletto catheter system, a device specifically designed for the delivery of genes. The injection procedure is performed by a cardiologist in a standard cardiac catheterization laboratory. The company currently has a distribution and development agreement with Boston Scientific for use of VEGF-2 in a delivery platform for the treatment of cardiovascular disease. Via that arrangement, first disclosed in mid-2003, Boston Sci acquired a 17% stake in the company, with the most recent stock purchase of 4.3 million Corautus shares valued at about $18 million having taken place this past June

Jack Callicutt, vice president of finance and administration, told CDU that the trial setback doesn’t affect its relationship with Boston Scientific at this time. “They’re still the largest shareholder of the company,” he said, adding that Boston Sci still has “the worldwide marketing rights for any of our therapeutics, and we still have a really good relationship with them.”

CEO Richard Otto expressed disappointment in the need for trial termination, particularly in light of the promise shown in the company’s earlier trials for the angina application. The study had already received two positive interim safety analysis recommendations from the DMC, with the most recent one conducted after the first 115 patients were treated in the trial.

Volcano files for IPO

Volcano Therapeutics (Rancho Cordova, California) has filed with the SEC for an initial public offering of stock to raise up to $86 million, all of the shares to be offered by the company. The filing did not detail the number of shares to be offered or their pricing.

Volcano manufactures a suite of intravascular ultrasound (IVUS) and functional measurement (FM) products for the diagnosis and treatment of vascular and structural heart disease. The company explains in its filing: “Our IVUS products consist of consoles, single-procedure disposable catheters and advanced functionality options. FM devices measure the pressure and flow characteristics of blood around plaque thereby allowing physicians to gauge the plaque’s impact on blood flow and pressure. Our FM products consist of pressure and flow consoles and single-procedure disposable pressure and flow guidewires.”

Volcano also is developing customized versions of its consoles “and advanced functionality options” as part of what it calls a “vfusion cath lab integration initiative.” The vfusion offering will include cath lab-integrated IVUS and FM capabilities, real-time Virtual Histology with color-coded identification of plaque composition, automatic real-time drawing of lumen and plaque borders, and IVUS and angiographic image synchronization, or co-registration, in two- and three-dimensions.

The company in 2005 reported revenues of $91.9 million in product sales and said that as of Feb. 28,it had a worldwide installed base of more than 1,400 IVUS consoles and more than 700 FM consoles.