A study assessing Boston Scientific's (Natick, Massachusetts) EZ FilterWire to catch bits of plaque and blood clot that break loose during percutaneous coronary intervention (PCI) in patients with acute coronary syndrome has been discontinued after it failed to show that it can reduce rates of major cardiovascular complications.
The A-F study was presented in a late-breaking clinical trials session at the annual meeting of the Society for Cardiovascular Angiography and Interventions (SCAI; Washington), in partnership with the American College of Cardiology (ACC; Washington) at the organization's annual meeting in Chicago in late March.
The EZ system was first approved by the FDA in August 2004 for use in coronary saphenous vein graft, and then for the application of carotid artery stenting in 2006.
The device is a coronary guidewire, with a plastic sack attached to it shaped like a windsock. The windsock-like sack features small holes allowing blood to flow through but catching larger debris. During PCI the FilterWire is positioned in the coronary artery downstream of the lesion; both the device and, with it, any debris are removed after the procedure.
The study was originally designed to include 450 patients but was stopped after an analysis of the first 150 patients. The researchers found that rates of major cardiovascular complications during hospitalization — consisting of death, heart attack, emergency bypass surgery, or repeat procedure in the treated artery — were no different in the two groups (12% in the FilterWire group vs. 10% in the control group).
Investigators were focused on patients with arterial blockages that appeared particularly likely to be a source of downstream debris during PCI. In addition, myonecrosis, or debris-caused damage to the heart muscle resulting from blockage of tiny blood vessels, is fairly common. PCI is associated with myonecrosis in about 25% of patients with non-ST-elevation myocardial infarction (STEMI) acute coronary syndromes. The condition also encompasses unstable angina.
"This was a study in a new population," Mark Webster, MD, director of the cardiac catheterization laboratory at Auckland City Hospital (Auckland, New Zealand), told Cardiovascular Devices & Drugs. And he called this group "the bread and butter of our work: unstable angina patients. We tried to pick a high-risk group within that population. They were required to have pain at rest and other features, like being at risk for distal embolism."
Although the FilterWire captured debris in the bloodstream in nearly half of patients, it did not reduce damage to the heart muscle. This was the first trial to evaluate a vascular protection device in patients with NSTEMI acute coronary syndromes. "Although there are other mechanisms, distal embolism of atherosclerotic plaque and/or thrombus is recognized to be a frequent cause," Webster said.
St. Jude to to acquire EP MedSystems for $92.1M
St. Jude Medical (St. Paul, Minnesota) reported that it has agreed to acquire EP MedSystems (West Berlin, New Jersey) for about $92.1 million, to bolster its presence in the market for irregular heartbeat devices. EP shareholders will receive $3 for each EP MedSystems share they own, with the option of receiving that amount in cash or St. Jude common stock. That price is more than double the closing price of EP's shares on Tuesday, when they closed at $1.41 on Nasdaq.
The number of shares of St. Jude common stock that EP shareholders will receive will be determined based on the average closing price over 10 trading days, ending on the second business day before the transaction closes. The cash and stock elections are subject to pro-ration such that St. Jude Medical will issue 40% of the total merger consideration in St. Jude common stock and 60% in cash.
St. Jude's board also approved an additional stock buyback authorization of $50 million, increasing its share repurchase authorization from $250 million to $300 million. The additional buyback authorization will be used to offset the shares issued in this transaction.
The companies anticipate the acquisition will close in 3Q08.
St. Jude said this transaction will immediately add two new growth drivers to its program for products used in atrial fibrillation (AF) and other electrophysiology (EP) catheterization procedures. This includes the EP-WorkMate computerized electrophysiology workstation with a fully integrated EP-4 Computerized Cardiac Stimulator and expansion options to incorporate the NurseMate Remote Review Charting Station. The EP-WorkMate platform already enjoys a number two share of the global market for EP recording systems in spite of limited sales and marketing resources, the company noted.
St. Jude also said the EP buy will expedite its entry into the intracardiac ultrasound echocardiography (ICE) market with the EP's ViewMate II intracardiac ultrasound system and the next generation ViewFlex PLUS ICE catheter scheduled for market release this quarter. This market is growing at an estimated 25% to 30% per year and includes both EP and interventional cardiology applications.
Full year 2007 net sales for EP were about $19 million.
"This transaction will accelerate the growth of St. Jude Medical's program to help physicians cure atrial fibrillation," said Daniel Starks, president/CEO and chairman of St. Jude. "EP MedSystems' new ClearWave signal recording technology and its next generation ViewFlex PLUS ICE catheter will be especially important additions to our AF technology platform."
David Bruce, president/CEO of EP, said, "This transaction delivers significant shareholder value and enables our key product platforms to benefit from the extensive worldwide distribution, customer support and product development infrastructure of St. Jude Medical." Following the close of the transaction, Bruce is expected to join St. Jude, and EP will become part of the company's AF division.
Bear Stearns (New York) med-tech analyst Rick Wise wrote in a research note that the acquisition "provides true 'plug & play' add-ons to St. Jude's already well established AF & EP platform."
He also noted that the EP WorkMate System will be an adjunctive therapy to St. Jude's current EnSite mapping/navigation software. Wise said WorkMate provides cardiac recording capabilities not available on St. Jude's EnSite platform.
"The addition of WorkMate further solidifies St. Jude's already broad AF product portfolio, and offers physicians another tool to help in the process of diagnosing and treating AF." With the addition of EP, Wise said he believes St. Jude's AF unit will grow 20% or more over the next 2-3 years.
Vasogen restructures, cuts 85% of workforce, will 'refocus'
Vasogen (Mississauga) reported that because of regulatory delays it is forced to implement a drastic restructuring to significantly reduce its cash burn and focus efforts on opportunities that it says are best able to provide long-term value.
The company said the plan re-focuses company resources on development of its VP series of inflammatory disorder drugs while the company seeks alternatives to fund further development of the Celacade System, the company's technology for the treatment of chronic heart failure.
The restructuring slashes Vasogen's workforce by about 85%, roughly 88 of the company's 104 full-time employees. It estimates having about two years of cash resources once the restructuring is complete. The company said it will have cash expenditures of about $2.6 million during the second quarter related to the restructuring.
It has retained JMP Securities to assist it in exploring other alternatives.
Vasogen in March reported delays with the FDA regarding the design of Advanced Chronic Heart Failure CLinical Assessment of Immune Modulation Therapy (ACCAIM II), a clinical trial to support an application for U.S. market approval of Celacade for the treatment of patients with NYHA Class II heart failure.
It said that because of lack of access to capital and the FDA's opposition to "a relatively small trial utilizing a Bayesian statistical design," it has put on hold plans to fund ACCLAIM II, but that it will continue to work with the FDA to finalize the design of the trial and evaluate alternatives to fund such a study.
Vasogen also said that because of a much lower-than-anticipated revenue forecast for Celacade from its European marketing partner, Grupo Ferrer (Barcelona, Spain), it will halt "operational and financial support" for European commercialization and is exploring alternatives with Ferrer. It said that Ferrer's sales forecast was impacted by uncertainties surrounding the ACCLAIM II trial.
Chris Waddick, president/CEO of Vasogen, said, "the science underlying Celacade remains strong, and ... the rationale for its therapeutic use in the treatment of certain heart failure patients was evident in the subgroup analysis from the ACCLAIM trial. For these reasons, we plan to explore opportunities to support the further development of Celacade in the U.S. and continue working with Ferrer to evaluate alternative strategies to support the commercialization of Celacade in Europe."
Celacade technology targets the inflammation underlying chronic heart failure (CHF). Oxidative stress is known to initiate apoptosis (programmed cell death), a process that is inherently anti-inflammatory, according to Vasogen.
During an outpatient procedure, a sample of a patient's blood is drawn into the Celacade single-use cartridge and exposed to controlled oxidative stress. The treated blood is then readministered to the same patient intramuscularly. An initial course of treatment of three consecutive procedures is administered over a two-week period, with treatments then continued once a month.
The initial ACCLAIM trial studied 2,408 subjects with CHF at 175 clinical centers in seven countries. ACCLAIM II was designed to assess the ability of Celacade to reduce the risk of death or first cardiovascular hospitalization.
Vasogen said its VP family of drugs are based on synthetic 3D phospholipid-based structures with specific groups of surface molecules designed to modulate cytokine levels and control inflammation.
VP025, the lead product candidate from this new class of drugs, is being developed for the treatment of neuro-inflammatory disorders. VP015 is another product candidate from this class of drugs, with the potential to treat other inflammatory conditions, according to the company.
Abbott's bioabsorbable stent trial shows promise out to one year
Drug-eluting stents (DES) have gone a long way toward reducing restenosis in cardiac patients after percutaneous coronary intervention. But they've also created a host of potential complications from impairing imaging to hindering surgical revascularization or positive remodeling (an increase in arterial area).
A new bioabsorbable stent being tested by Abbott Laboratories (Abbott Park, Illinois) may solve some of those problems. One-year results from a study of 30 patients who have had bioabsorbable everolimus eluting stents implanted demonstrated no stent thrombosis, no clinically driven target lesion revascularizations (retreatment of a diseased lesion), and a low (3.3%) rate of major adverse cardiac events (MACE).
"Doctors tell me their patients often ask, 'How long do I have to have this stent inside me?'" Richard Rapoza, PhD, VP of R&D for the bioabsorbable stent program at Abbott, told CD&D. "They don't understand or like the idea that they are permanent. For patients who have angioplasty, their vessels regrow in one to five years, but if you have a metallic stent, that's not a possibility. Now we are able to restore that possibility, we have a stent that degrades."
Abbott said theirs is the first degradable stent to ever be tested in humans.
The bioabsorbable stent has a backbone of poly-L-lactic acid that provides the support and a coating of poly-D,L-lactic acid that contains and controls the release of the antiproliferative agent everolimus. Polylactic acid is a substance commonly used in medical implants such as dissolvable sutures. The substance reacts to water and is absorbed by the body over time.
Patients included in the trial had either stable, unstable, or silent ischemia and a single lesion that was suitable for treatment with a single 3.0 12 mm or 3.0 18 mm stent. Rapoza pointed out they were 60 to 70 years old and did not have complicated disease and no calcifications.
They were enrolled from four academic hospitals in Auckland, New Zealand, Rotterdam, the Netherlands, Krakow, Poland, and Skejby, Denmark. The composite endpoint was cardiac death, myocardial infarction and ischemia-driven target lesion revascularization. Researchers are checking patients at 30, 180 and 270 days, with an annual follow-up for up to five years, on blood clot formation rates.
No late stent thromboses were recorded. At six-month follow-up, the angiographic in-stent late loss was 0.44 mm and was mainly due to a mild reduction of the stent area.
Abbott's stent loses mechanical structure in three to five months and the vessel can begin to move freely. "It holds an artery open long enough for healing to occur," Rapoza said. Remnants of the structure can remain up to two years after implantation. "We would expect an artery that is healed to function as it did before it became diseased."
Rapoza said plans are in the works to launch a larger study in Europe, although Abbott has yet to release those details.
Conor trying new DES effort with sirolimus drug coating
Conor Medsystems (Warren, New Jersey), acquired early last year for $1.4 billion by drug-eluting stent (DES) maker Cordis (Miami Lakes, Florida), suffered a major downturn in its developmental prospects later in the year with the failed-endpoint results of its COSTAR II study.
But it now is taking another stab at DES development.
Conor reported in late March that it will launch a new trial of a Sirolimus-eluting DES, incorporating a new cobalt chromium reservoir-base stent design, and comparing the stent to the Taxus Liberte Paclitaxel-eluting DES from Boston Scientific (Natick, Massachusetts).
In the COSTAR II trial, Conor CoStar stent failed to achieve non-inferiority for in-stent late loss vs. the Taxus, with the company attributing the failure to the use of "very low doses" of the drug paclitaxel.
At the time, it said it would move to the use of Sirolimus for its next try at DES development, though still using its architecture of tiny reservoirs on the stent as repositories for the eluted drug.
The new trial, dubbed RES-ELUTION, will be a randomized, multi-center comparison of the two stents in de Novo native coronary artery lesions. Primary endpoint of the study is angiographic in-stent late lumen loss at six months. The Conor Stent contains the same drug, sirolimus, as in Cordis' Cypher DES.
Secondary endpoints include target lesion failure, target vessel failure, major adverse cardiac events, stent thrombosis, target lesion revascularization, target vessel revascularization, and angiographic in-stent and in-segment binary restenosis at six months. Up to 50 patients will also be evaluated via intravascular ultrasound at six months, the company said.
The study will involve 388 patients at 40 sites in Australia, Belgium, Brazil, Denmark, France, Germany, New Zealand, the Netherlands and the UK. Patients will receive clinical follow-up at 30 days, six months and annually through five years.
New polymer-free DES, with 60% less drug, effective in patients
MIV Therapeutics (MIVT; Atlanta) reported promising results from a trial of its polymer-free VESTAsync drug-eluting stent (DES) at last month's American College of Cardiology meeting, saying that it has the potential to deliver DES-type efficacy with bare-metal stent (BMS) safety, and short-term anticoagulant therapy.
The data also suggest that the stent may allow for the delivery of 60% less drug than most DES devices.
"It has been well-documented by experts in the field that polymers cause some form of delay in healing," Mark Landy, MD, president/CEO of MIVT, told CD&D. "When you put a bare-metal stent in an artery, it heals naturally and quickly. The stent becomes cocooned in a nice layer of tissue.
"Polymers by themselves are relatively inflammatory ... so you have to treat the inflammation and you can cause more harm than good with respect to healing," he told CD&D. "You maintain a nice lumen with the drug eluting stents, but the opportunity to thrombose because it's not really healed is there. That's what led us to look at polymer-free systems."
Jose Costa, MD, of Institute Dante Pazzanese of Cardiology (Sao Paulo, Brazil) discussed the data at the ACC meeting.
Researchers concluded that the polymer-free, nanoscale microporous hydroxyapatite stent demonstrates excellent efficacy and safety. Costa presented nine-month follow-up intravascular ultrasound data for 11 patients who demonstrated a volumetric obstruction of 3.8% (+/- 2.3%) vs. 2.8% (+/- 2.2%) at four months.
This was a first-in-man trial of MIV's VESTAsync drug-eluting stent.
The study concluded that there was no significant difference between the four- and nine-month results, and that the observed degradation was uniform across all patients, with no outliers. No late-acquired incomplete stent apposition, stent thrombosis or major adverse coronary events were reported.
GE Healthcare in launch ofsmaller, more accessible Vivid S5
GE Healthcare (Waukesha, Wisconsin) says it is scaling down both the size and cost of big cardiovascular ultrasound equipment with a product that's more accessible to physician offices and imaging centers, launching the mobile Vivid S5 cardiovascular ultrasound system.
The Vivid S5 features stress echo capabilities and raw data digital imaging with console benefits of a full-sized 17 inch LCD monitor, four active transducer connectors and room for on-board peripherals retained in a miniaturized console weighing less than 160 pounds. Standard machines of similar purpose weigh up to 400 pounds and have a larger footprint, according to GE.
"We're now moving our console technology, with the same level of performance into a mid-price range for smaller clinics and doctor's offices," Al Lojewski, global marketing manager for cardiovascular ultrasound technology at GE, told CD&D.
Vivid S5 costs $60,000 to $90,000, compared to standard models that range in price form $100,000 to $200,000, he said. While the larger units provide 4-D imaging, the Vivid model has 2-D imaging.
The new system features the "ergonomically friendly" features of its sibling, Vivid S6, according to the company, and Flex-Fit mechanism enables continuous pivoting height adjustment of the control panel, keeping optimal distance from the user and leaving legroom for standing or sitting.
A Flex key, next to the trackball, can be assigned to assume the function of other, more distant keys for minimal effort, increased speed and ease of use. The high contrast wide-angle display monitor includes an auto sensor, automatically adjusting brightness, contrast and gamma levels for environment light, ensuring minimal eyestrain.
New name, new management in place for ex-BMS imaging unit
Bristol-Myers Squibb Medical Imaging (North Billerica, Massachusetts) has adopted a new name, Lantheus Medical Imaging, and a new management team. The company says that this builds on momentum created by the recent acquisition of the business by Avista Capital Partners.
Don Kiepert was named president/CEO of Lantheus. Previously, Kiepert was the founder, former president/CEO and chairman of Point Therapeutics.
Lantheus also added key members of its management team: Phillip Lockwood, VP of HR, formerly VP of HR at Indevus Pharmaceuticals; and Michael Duffy, VP and general counsel, formerly senior VP/general counsel at Point Therapeutics. In addition, David Mann, formerly VP of sales, was promoted to VP of sales and marketing.
Additional members of the management team include Peter Card, VP of strategy and business development; William Dawes, VP of manufacturing and supply chain; Scott Edwards, VP of global R&D; Robert Gaffey, VP of finance and operations; and Cyrille Villeneuve, GM Canada, Latin America, Pacific Rim.
Lantheus develops imaging products that illuminate the heart and other organs.
Cambridge to offer wireless tech for under $10
Cambridge Consultants (Cambridge, UK/Cambridge, Massachusetts) has entered the wireless-connection battle with what it terms its "breakthrough software solution," the Vena platform. The Vena is comprised of a single chip that is designed to allow devices, such as pressure monitors, to transmit data wirelessly.
The company said this plastform consumers, especially those with chronic conditions, the ability to monitor their own health systematically and independently. The platform uses low-cost wireless technology and will allow devices to deliver medical readings to a central monitor located in the home, or even to an online health record such as Google Health or Microsoft Health Vault.
Paul Williamson, head of wireless medical at Cambridge Consultants, told CD&D that his company is confident that the $10 price point will attract many buyers to the technology from a materials point of view." Williamson said that past generations of wireless technology have been relatively high cost because there have been no industry standards for such technology, making it for the most part proprietary and "low-volume and high-cost."
The Vena platform uses high-volume Bluetooth technology, and Cambridge noted that it embeds both the emerging IEEE11073 standard, which ensures compatibility of data exchanged between different types of devices, and the emerging Bluetooth Medical Device Profile, optimized for the secure transport of medical data, onto the single chip.
Williamson noted that Bluetooth technology is so cheap that the company is able to provide "a low cost consumer price point for the platform hardware. "The Vena platform can easily be built into devices at any stage of the design or production process," he said. "This ease of implementation makes it possible that medical devices with wireless capability could be commercially available before the end of 2008."
Masimo and Schiller in patient-monitoring solutions pact
Masimo (Irvine, California) reported an agreement with Schiller (Zurich, Switzerland), a supplier of electrocardiographs, spirometers, patient monitors and external defibrillators, to integrate the Masimo Rainbow SET technology platform as the foundational technology of choice for all its patient monitoring solutions worldwide.
Masimo Rainbow SET measures total hemoglobin and oxygen content (both pending FDA clearance), in addition to carboxyhemoglobin methemoglobin, pleth variability index, oxyhemoglobin, perfusion index (PI) and pulse rate.
The ability to quickly and continuously measure SpHb, SpOC, SpMet, SpCO, PVI, SpO2, PR, and PI noninvasively may help clinicians to save lives by more rapidly diagnosing potentially life-threatening conditions, speeding treatment decisions and improving patient outcomes.
Masimo says that SpHb may make hemoglobin testing quick, convenient and accessible to medical personnel in both acute and outpatient settings — enabling them to quickly identify conditions of anemia, or blood loss. The availability of real-time continuous SpOC may help to ensure optimal oxygen delivery in patients during rapidly-changing clinical situations.