CardioGenesis (Foothill Ranch, California) has become the second medical technology company to elect to pursue a product approval via the FDA's Medical Devices Dispute Resolution Panel (MDDRP) after its attempts to seek a clearance in the traditional manner fell short. It can only hope that the outcome will be as positive as was true the first time around. CardioGenesis, a developer of angina-relieving Transmyocardial Revascularization (TMR) and Percutaneous Myocardial Revascularization (PMR) technology, said last month that an independent panel review of the scientific dispute, in connection with the company's pending premarket approval (PMA) application for its PMR System, has been granted by the FDA.
The only other company to pursue the panel resolution process was Lifecore Biomedical (Chaska, Minnesota), which received a "thumbs up" from David Feigal, director of the FDA's Center for Devices and Radiological Health (CDRH), in October 2001, after a unanimous 4-0 decision from the dispute resolution panel the previous month for the company's Gynecare Intergel Adhesion Prevention Solution.
CardioGenesis' PMR process, which already has the CE mark, is a catheter-based procedure in which physicians use a laser to create tiny channels in the heart muscle to trigger the mechanisms of angiogenesis, or the creation of new blood vessels in the heart. It is related to TMR, a similar laser cardiac procedure developed by the company that is performed by a surgeon and which received approval from the FDA in 1999.
Chairman and CEO Michael Quinn said the company understands the unique challenges an innovative new technology can present to the FDA, and is encouraged by the agency's decision to provide an impartial forum for consideration of the evidence by qualified experts. "We are confident that the PMR supplement contains adequate valid scientific evidence to support a determination of reasonable safety and efficacy of the PMR system," Quinn said. "This action on the part of the ombudsman in the Center for Devices and Radiological Health and MDDRP executive secretary confirms that our scientific dispute with the Office of Device Evaluation is substantive, and that the FDA agrees the matter is sufficiently complex and important to convene the MDDRP."
CardioGenesis, which has previously acknowledged frustration over the lengthy course of its PMA submission and the subsequent turndown of its supplement filing at the beginning of the year, hopes to expedite matters just as Lifecore did by pursuing the panel resolution, even though such a pathway is an "all or nothing" gamble. The PMR system has been under evaluation in pivotal human clinical trials since 1997. The current PMA application was filed with the FDA in December 1999 and amended in July 2002 to address concerns raised at an FDA advisory panel meeting. Late last year, the Office of Device Evaluation determined that, in its opinion, there was not sufficient information to demonstrate reasonable assurance of PMR's safety and effectiveness. Quinn said his company hired the same attorney team that was involved in the Lifecore panel dispute. He said the lawyers told them, "you guys have a very strong case."
The company thought it had addressed the safety concerns raised by the FDA when it filed its PMA supplement last July with the addition of 12-month follow-up safety data from the Blinded Evaluation of Laser PMR Intervention Electively for Angina Pectoris (BELIEF) trial, but apparently the reviewers either did not find the data compelling enough or had a hard time wading through all the added documentation.
In hindsight, Quinn said the company may have provided too much information to the reviewers in the supplement submission. "I think when we look at the supplement now, we overkilled it." With the panel resolution, he said the company will now focus on the key points in the presentation of both efficacy and safety data. "They outlined certain things that they wanted us to elaborate on and that's what we're going to do."
The company said it expects the MDDRP to convene sometime in 2Q03. The panel will make a determination and recommendation to Feigal.
Quest finally closes on Unilab transaction
After the Federal Trade Commission (FTC; Washington) gave its long-delayed blessing to Quest Diagnostics' (Teterboro, New Jersey) acquisition of Unilab (Tarzana, California), the companies finalized the deal late last month. The deal was first disclosed in the spring of 2002 and originally had a value of about $1.1 billion. That number has been scaled down to around $827 million, which includes the assumption of Unilab's debt.
As part of an agreement with the FTC, Quest will divest certain assets in Northern California to Laboratory Corporation of America (LabCorp; Burlington, North Carolina) for $4.5 million in cash. The assets to be sold to LabCorp include the assignment of four capitated contracts with independent physician associations, as well as the leases for 46 patient service centers, five of which also serve as rapid response laboratories, located throughout Northern California. The assets will transition to LabCorp over a period of about six months.
The divestiture of those assets was key to the FTC finally giving its nod to the deal, after multiple delays in the process due to that agency's concerns over the potential for reduced competition for clinical lab services in northern California. Without the divestiture, the Quest/Unilab transaction would have resulted in possible price increases, the FTC said.
Quest has acquired all of Unilab's operations, including three full-service laboratories, 35 rapid-response laboratories and 367 patient service centers. "This transaction positions Quest Diagnostics for profitable growth in California and enhances service for healthcare customers throughout the state," said Kenneth Freeman, chairman and CEO.
Quest, which bills itself as the nation's leading provider of diagnostic testing services, has a national network of about 1,350 patient service centers, 30 principal labs in metropolitan areas, and about 100 smaller stat laboratories. Unilab, according to FTC estimates, is the largest supplier of lab testing services in California.
Viasys forming anesthesia products company
Viasys Healthcare (Conshohocken, Pennsylvania) is forming a new company to focus on the anesthesia market. Viasys Anesthesia Products will report to Tom Kuhn, president of the Viasys MedSystems Group. The unit will have headquarters at the Viasys facility in Wheeling, Illinois. Kuhn said Viasys Anesthesia Products would provide focus to the company's expanding line of anesthesia offerings, including SNAP, a hand-held device to measure brain activity while under anesthesia, and HiOx80, a device for minimizing post-operation nausea.
"Other anesthesia products are under development at Viasys and we intend to actively pursue in-licensed and acquired products," said Kuhn. "Anesthesia is a natural market for Viasys since it falls at the intersection of our two largest competencies, respiratory and neuro medicine. This initiative also complements the Viasys strategy of growing the volume of recurring-revenue disposables."
Frank McCaney, senior vice president of business development, said that the group is being formed for two reasons: to give a focus to new products and a new market, and because anesthesia is "really the intersection" of two groups the company already focuses on: neuro medicine and respiratory. McCaney said the company would be "trying to move more and more to disposable" products, whether it be airways or masks. The anesthesia unit will be starting with about 12 sales and marketing employees, but that number should rise to about 20 to 22 in the field by year-end 2003. The anesthesia products group will be targeting outpatient centers and hospitals. "It's a market that is ripe for innovation," McCaney said.
Viasys is focused on respiratory, neuro care and medical/surgical products. Its products are marketed under brand names such as SensorMedics, Bird, Bear, Nicolet and Jaeger.
Streamlining imaging diagnostics
GE Medical Systems (GEMS; Waukesha, Wisconsin) and Brigham and Women's Hospital (Boston, Massachusetts), a 721-bed non-profit teaching affiliate of Harvard Medical School (also Boston), are working together to implement an Evidence-Based Medicine System designed to streamline the diagnostic imaging process.
Medicalis, a company that was founded in 1999 further augmented by a spinout of employees and a software product from Mitra Imaging in July 2002 has one of its major goals the commercialization of evidence-based decision support solutions being developed at the hospital. With this mandate, Medicalis is heading the collaborative streamlining and database effort being undertaken by GEMS and the hospital which, with Brigham Radiology Research and Education Foundation, is one of the company's majority shareholders.
The aim of the Evidence-Based Medical System is to provide physicians the ability to compare an individual patient's symptoms with thousands of other relevant patient histories, in addition to relevant medical literature and best practice guidelines. All of this is designed to help a physician make the best decision regarding which type of imaging test he or she wants to order for a given patient, when evaluated in the context of all the information provided by the system. Without the additional information, a physician orders imaging tests based on his or her experience alone, in evaluating a patient's symptoms.
"We know that there is testing that's performed that's either not necessary or not targeted enough to find the right diagnosis for the symptom," Vishal Wanchoo, vice president of imaging and information systems for GE Medical Systems Information Technologies, said. The Brigham database is interfaced with a web-based order entry system. At the point that a doctor orders a test for a group of symptoms which are similar to others, he then can see what kind of imaging test led to the best diagnosis for those other patients at the hospital. Wanchoo says the effect is to provide doctors more tools for critical decision-making.