CardioGenesis (Foothill Ranch, California), a developer of surgical products used in angina-relieving transmyocardial revascularization (TMR) and per-cutaneous myocardial channeling (PMC) procedures, reported in the latter part of December a foray into new territory with the launch of the CelleratOR system for the point-of-care preparation of autologous platelet-rich plasma. Chairman and CEO Michael Quinn said the company was looking for "new tools" and unique areas to pursue new revenue sources.

The system consists of a small centrifuge system and proprietary disposables to prepare the platelet concentrate from the patient's blood sample. Quinn said that the system is simple to use and provides the advantage of scalability over competitive systems. "The concentration level can be determined by the physician at the time of preparation. The end result is a concentration of the patient's own platelets from a small blood sample."

CardioGenesis formally launched the system late last month at the annual meeting of the Society of Thoracic Surgeons (STS; Chicago) in Tampa, Florida. The company highlighted the CelleratOR technology, along with its minimally invasive TMR tools currently in the regulatory process, at an educational symposium in conjunction with the STS meeting. "This technology is just gaining awareness in cardiovascular medicine," said Quinn, adding that CardioGenesis "intend[s] to lead the way in developing the application of autologous platelet-rich plasma by working closely with our technical and clinical advisors in identifying potential new applications in the cardiovascular arena."

He said the company's focus "is to add new exciting technology to our marketbasket. We were attracted to the CelleratOR technology because of its potential for contributing to improved patient outcomes. The benefits of this technology are known and embraced in several surgical specialties ... CelleratOR is our first new product beyond laser myocardial revascularization devices, and we expect it to be a useful addition to patient-centered cardiovascular medicine."

Richard Lanigan, senior vice president of marketing, told Cardiovascular Device Update that the system, which CardioGenesis licensed for cardiovascular use from an unnamed holder of the technology rights, was brought to the company's attention by some of its current customers "as a product that they utilized, and [that] got our attention." His company saw the first clinical data published on the use of the system in the cardiovascular field at the beginning of last year, he said. What they found is that the system already is being used to some extent in the cardiovascular sector. "In some cases, it's being used as an adjunct therapy in all of their cardiovascular cases and in some cases it's just used by exception," Lanigan noted. While the product is relatively new to the cardio market, it already is "more established" in the fields of orthopedic, dental and plastic surgery, he said.

Quinn said that CardioGenesis wants to bring "new tools" to address advanced cardiovascular disease and the related co-morbidities of those patients referred to cardiovascular surgery. He expressed optimism that the company could pursue this "exciting new opportunity" without compromising its current core technologies. "While we are committed to growing the TMR business with the innovative new minimally invasive products we have developed with key clinical champions to expand that market, we also are committed to adding additional tools and innovative new products going forward," he said.

In recent years, CardioGenesis has been stymied in its attempts to get its PMC device approved in the U.S. PMC is a less-invasive, catheter-based version of the FDA-approved surgical TMR system, designed to trigger the mechanisms of angiogenesis, or the creation of new blood vessels in the heart to relieve the often-crippling chest pain called angina via the use of a Holmium:YAG laser. The PMC system has been under evaluation in pivotal human clinical trials since 1997. The current premarket approval application (PMA) application was filed in December 1999 and amended in July 2002 to address concerns raised during an advisory panel meeting. Late in 2003, the FDA's Office of Device Evaluation determined that, in its opinion, there was not sufficient information to demonstrate reasonable assurance of PMC's safety and effectiveness.

Last March, CardioGenesis reported that the FDA was "unable to reach a favorable outcome" for the company's supplemental PMA for PMR following a meeting earlier that month with the Center for Devices and Radiological Health. In August, the company said that it and the FDA have agreed on the steps needed to design and initiate a new clinical trial to confirm the safety and efficacy of the beleaguered PMC product.

Besides giving the company another product to sell in the cardiac operating room as well as to cardiologists, Lanigan said CardioGenesis believes there may be some synergistic opportunities with its PMC system that will be explored in future studies. "That will be one of the areas we research in addition to the current market that we'll be pursuing in terms of just the cardiac OR." Lanigan said that this new initiative, along with the imminent approval of minimally invasive surgical tools for TMR, are just two examples of how CardioGenesis is planning to counteract the delays in PMC approval.

Millionth Taxus DES implanted

Boston Scientific (Natick, Massachusetts) in January reported the implantation of its millionth Taxus Express2 paclitaxel-eluting coronary stent system, marking an obviously important milestone for the company. The Taxus received the CE mark in January 2003 and FDA approval in March 2004. "The implantation of our millionth Taxus stent system is a significant symbolic achievement for Boston Scientific," said Jim Tobin, president and CEO. "We are gratified that the Taxus system has become the preferred treatment option for clinicians, but more important, we are pleased that so many patients have benefited from this innovative, life-enhancing technology."

Gregg Stone, MD, director of cardiovascular research and education in the Center for Interventional Vascular Therapy at Columbia University Medical Center (New York), said, "This is a noteworthy milestone for Boston Scientific, for physicians and for patients. This product has truly revolutionized how we treat coronary artery disease and dramatically advanced the practice of interventional cardiology."

Boston Scientific also reported last month that it had launched the Taxus Libert paclitaxel-eluting stent system in 18 countries. The Libert is the company's next-generation coronary stent. It plans to launch the Taxus Libert system in Europe later this year and in the U.S. next year, subject to regulatory approval.

Edwards, St. Jude pact ends litigation

Edwards Lifesciences (Irvine, California), a leader in the heart valve sector, reported entering into an agreement with St. Jude Medical (St. Paul, Minnesota) resolving patent infringement litigation between them. The lawsuit in question was initiated by Edwards in June 2000, related to certain of its patents in the areas of heart valve repair and replacement. With the settlement, Edwards will receive a one-time cash payment of $5.5 million; St. Jude will receive paid-up licenses for certain of its heart valve therapy products. Further details of the settlement were not disclosed.

The litigation, filed in U.S. District Court in California and the Federal Court of Canada in Ontario, has been dismissed, Edwards said. It said the settlement would have no material impact on its finances.

"We are pleased to have resolved this dispute, as it marks the conclusion of a related group of lawsuits we filed against several competitors alleging infringement of some of our core heart valve therapy intellectual property," said Michael Mussallem, Edwards' chairman and CEO, in a statement. "We are committed to protecting the interests of Edwards and our clinician-inventor partners, with whom we work to create new technologies for the treatment of advanced cardiovascular disease."

Edwards bills itself as the No. 1 heart valve company in the world and the global leader in acute hemodynamic monitoring. Its brands include Carpentier-Edwards, Cosgrove-Edwards, Fogarty, Life-Stent, Perimount and Swan-Ganz. St. Jude Medical is a competitor in the cardiovascular space.

Redding cardiologists to pay $24M

In another legal matter, former cardiac care patients at Redding Medical Center (Redding, California) have reached an agreement in which four cardiologists will pay $24 million to settle claims arising from charges of unnecessary cardiac catheterizations and bypass surgeries performed at the hospital before November 2002, according to the law firm of Reiner, Simpson, Timmons & Slaughter (Redding) and co-counsel. The agreement boosts pending Redding Medical Center-related settlements to $419 million.

Tenet Healthcare (Dallas) in December agreed to settle substantially all claims brought by more than 770 former Redding cardiac care patients against the company and its subsidiaries. Tenet established a $395 million fund to be allocated among the former patients.

Suits were filed against the Redding Medical Center after the FBI raided the offices of two cardiologists and the medical center in late 2002. Among the four cardiologists settling is Chae Hyun Moon, the center's former chief of cardiology, and Fidel Realyvasques, its former top cardiac surgeon. Both left the hospital in early 2003, according to The Record Searchlight, a Redding newspaper.

Robert Simpson, of Reiner, Simpson, Timmons & Slaughter, said, "Tenet and now the cardiologists have moved to bring this matter to a fair and honorable conclusion. It is time for the surgeons to do the same." Liaison counsel Russell Reiner of the law firm added: "We are prepared to work toward resolution with the surgeons but have found no willingness on their part to do so." He anticipated that a jury "will be forced to end this sad chapter in our community's history." A trial is set for July 25.

In 2003 Tenet agreed to pay the federal government and the state of California a total of $54 million in what officials called the largest-ever settlement for allegations of unnecessary surgeries, stemming from an investigation of the Redding hospital. The U.S. Attorney's office said the $54 million covers procedures performed under Medicare, Medicaid and Tricare programs.

CMS payments increase for EECP therapy

Vasomedical (Westbury, New York), which focuses on the non-invasive treatment and management of cardiovascular diseases, reported that changes to the Physician Fee Schedule for 2005 published recently by the Centers for Medicare & Medicaid Services (CMS; Baltimore) will result in a new national average payment level of $138.34 per session for enhanced external counterpulsation (EECP) therapy. The new average payment for physicians reflects a 10.9% increase for EECP therapy over the earlier proposed 2005 rate of $124.69. The national average reimbursement rate for EECP therapy administered in the hospital outpatient setting of $102.18 reflects a 3% decrease over the earlier proposed rate of $105.38.

Vasomedical's EECP systems are comprised of an air compressor, a computer console, a set of cuffs and a treatment table. In a treatment, patients lie on the table, their calves and lower and upper thighs wrapped in the cuffs. The system, which is synchronized to the individual patient's cardiac cycle, inflates the cuffs with air to create external pressure when the heart is resting (diastole) and deflates the cuffs just before the heart beats (systole). The system's action, which pulses counter to the heart's beating, increases blood flow to the heart muscle, decreases the heart's workload and creates a greater oxygen supply for the heart muscle while lowering the heart's need for oxygen, the company said.

CHF completes $22.9M offering

Privately held CHF Solutions (Brooklyn Park, Minnesota) has completed a $22.9 million offering of its convertible preferred stock. The company said it would use the proceeds to complete a clinical trial, called UltrafiltratioN vs. IV Diuretics for Patients HospitaLized for Acute Decompensated Congestive Heart Failure (UNLOAD), and expand the marketing for its Aquadex System.

The largest investors are MPM Capital and SV Life Sciences. Other investors are Investor Growth Capital, Kaiser Permanente Ventures, Brightstone Capital and Mason Wells Biomedical, along with several other existing investors. SV Life Sciences led the financing round and both SV Life Sciences and Kaiser Permanente Ventures are new investors in CHF Solutions.

Aquapheresis is a form of ultrafiltration that can remove up to four liters (about one gallon) of excess fluid from the body in eight hours. Unlike some drugbased therapies, Aquapheresis removes this fluid with no clinically significant impact on electrolytes, heart rate or blood chemistry.

The company said the procedure, using the company's Aquadex system, is highly automated, easy to use, transportable and can be performed in virtually any clinical setting. Standard catheters inserted into peripheral or central veins connect the patient to the Aquadex System. Recent technological advancements now will allow the therapy to be delivered via standard peripheral IVs, further improving the safety, ease and convenience of Aquadex therapy. Aquapheresis with the Aquadex system technology received 510(k) clearance in mid-2002 and is currently being used in 52 hospitals across the nation.

The UNLOAD trial, launched in mid-2004, is comparing the safety and efficacy of treatment with the Aquadex system to conventional pharmaceutical therapy (i.e. intravenous diuretics) in heart failure patients with fluid overload. The study will enroll 200 patients at as many as 30 U.S. clinical sites. Researchers will document outcomes during the patient's hospitalization and three months following discharge to demonstrate acute and sustained clinical benefit.

Novoste loses two-thirds of carryforwards

Embattled vascular brachytherapy provider Novoste (Norcross, Georgia) reported last month that two-thirds of its net operating loss (NOL) carryforwards will expire unused, as the result in an analysis of cumulative changes in the ownership of its common stock, The company said it recently evaluated the filings by certain stockholders in accordance with Securities and Exchange Commission (SEC) rules, as well doing its own review. As a result, it said, it "became aware ... of potential inaccuracies [in those filings] made by certain persons with the SEC during the past several years and has determined that certain purchases and sales of its common stock were not reported accurately."

It said that the defined "change in ownership" took place on Sept. 17, 2003, thereby imposing limitations restricting the timing and amounts of the future use of its available NOL carryforwards, with the resulting loss of two-thirds of them. The company previously reported in its consolidated financial statements included in its annual report for the year ended Dec. 31, 2003, that it had about $108 million of NOL carryforwards which were fully reserved and will expire beginning 2007 through 2023. The Internal Revenue Code imposes an annual limitation on the utilization of NOL carryforwards based on a statutory rate of return "and the value of the corporation at the time of a change in ownership," Novoste said.

Novoste said that, as of Sept. 17, 2003, the future use of NOL carryforwards is limited to $1.8 million annually and about $36 million in total. It also said that the change in ownership had no impact on reported net income or loss per share for the year ended Dec. 31, 2003, or the nine months ended Sept. 30, 2004. But any future changes in ownership "may result in significant additional amounts of these NOL carryforwards expiring unused," Novoste said.

The company also reported that it has "received inquiries from, and has engaged in discussions with, companies potentially interested in a merger or business combination" with it. Novoste previously reported that it is "actively" seeking new product opportunities, as well as a merger, business combination or other disposition of its business or assets, "due to the continuing challenges facing its vascular brachytherapy products business, which have resulted in a sustained decline in its revenues."

Abiomed launches service for heart recovery

Abiomed (Danvers, Massachusetts), maker of medical products designed to assist or replace the pumping function of the failing heart, reported the launch of an education and service program designed to promote heart recovery. The program combines clinical training, web-based education, process improvement and field service. "By providing clinical support and education on best practices including early implantation, time on support, and reducing bleeding, we can help our hospitals improve outcomes," said Michael Minogue, CEO and president of Abiomed. "Our goal is to give our customers the tools they need to help acute patients recover and go home with their own hearts."

The program includes web-based learning modules developed by eTrinsic (Louisville, Colorado), enabling clinical teams to be trained on the AB5000 and BVS 5000 using an interactive course that simulates the clinical experience. "The course simulates important aspects of this procedure so that clinicians and other healthcare professionals can now learn in a risk-free environment that is both compelling and realistic," said Jacques Devaud, CEO and president of eTrinsic.

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