In another in a series of breakthroughs for the defibrillator sector of cardiovascular technology, Philips Medical Systems (Best, the Netherlands) has received FDA clearance for its HeartStart Home Defibrillator, an automated external defibrillator (AED) specifically designed for use in the home or by those essentially untrained in AED use.

A system for preventing death by cardiac arrest, the HeartStart targets one of the major causes of fatality in the U.S. – and the largest portion of those fatalities, the 70% of cardiac arrests that happen in the home, with Philips noting that "the majority of those [attacks] are witnessed."

The essential difference between the HeartStart and other AEDs is the design of the instruction system which attempts to make the operation totally "intuitive," that is, usable by those completely unfamiliar with AEDs, even young children and the elderly. Besides having "clear, calm voice instructions," these instructions are "more comprehensive than those offered by AEDs used by trained first responders," according to the company. The instructions include additional prompts reminding the user to call for emergency help, and they provide instruction in CPR coaching.

Even the pacing of the coaching instructions will adjust to meet the individual user's use of the defibrillator pads via the Philips' SMART Pad technology, which senses the responder's actions and automatically adjusts to them.

"Patented voice coaching for adult and infant/child CPR provides voice instructions and audio cues for each breath as well as the appropriate number and rate of chest compressions," the company said in a statement. It went on to say that the system is totally maintenance-free because of functions for daily self-testing of components and pad readiness. It even provides "a loud chirp" to indicate that the system may need some attention, Philips said.

Deborah DiSanzo, vice president and general manager of cardiac resuscitation at Philips Medical Systems (Andover, Massachusetts), told Cardiovascular Device Update's sister publication, Medical Device Daily, that the system was developed as the result of 9,000 hours of simulation with one of the company's simplest AEDs. Philips engineers then made alterations to that system to fit what she termed "a na ve user."

She added, "We took it to less-trained users and said, 'What do we need to do to increase the success rate for people who are going to use it less than the currently trained user?'" As a for-instance, the company took the device and a Resus-Annie doll to assisted living centers and other places where people would have no previous instruction, gave them the device, and asked, "What will you do with this?" This was then followed by further modifications of the prompts and more simulations.

With filing of the company's 510(k) application, the company also committed, DiSanzo said, to do post-marketing studies of the product's effectiveness.

The post-marketing study will be enabled by information gathered by the device itself. "We'll be able to look at how soon the pads were [placed] on the patients, what the heart rhythm was, what the device recommended, the treatment given, when the pads were taken off," with that information then collected and analyzed. Gathering of the information from users will be facilitated by encouraging users to send the company the pads from the device and receive a new set at no cost.

The device is being priced at just under $2,300, which DiSanzo compared to the cost of laptops and home computer systems, but with this technology being one "that can save your life." She said that the company projects first-year sales of from 40,000 to 50,000 units, with a quarter of those likely to be purchased for home installation. In the home, the company is recommending placement in areas where residents spend most of their time or simply where access would be easiest.

She predicted that the earliest adopters of the device for home use would most likely be those with someone in the home with a heart arrhythmia, or simply those in the older age brackets at greater risk or who have had "some brush with heart disease," such as the cardiovascular death or illness of a friend or family member.

Within the Philips product mix, DiSanzo said that the HeartStart would "absolutely be a major product. Philips is a company that is not only a leader in medical technology but also a leader in consumer products." Thus, she described the device as "at a place where people interact with technology and make it a more pleasurable experience. A home defibrillator fits well in that business."

The frequently stated goal of the AED sector is to make AED devices as ubiquitous as fire extinguishers. While DiSanzo termed that "the long-range mission," she said it wouldn't come immediately and could take "upwards of 10 years."

More important than rapid roll-out, she said, was to do marketing "in a very thoughtful way and to educate the public on cardiac arrest."

Among those educational points, she said, was to emphasize the need for the most rapid AED when cardiac arrest happens, since the chances of survival drop quickly from about 50% with application at five minutes and "by the time it takes 10 minutes, less than 1% survival."

Another important point, she said, is to educate people about the difference between heart attack and cardiac arrest and that use of an AED can do more harm than good for the person having the type of heart attack that allows time to get to a hospital for treatment. By contrast, she called cardiac arrest "something different – an electrical malfunction of the heart. That's one of the things we need to educate the public about and it's a common question."

Another common question is how many lives each year the HeartStart might save if made widely available. "The American Heart Association {Dallas, Texas] has done that [math] for us," DiSanzo said. "If you put defibrillators in places where they can be used within four minutes, they could save 40,000 lives. That's significant and that is our goal."

Elsewhere in the product pipeline:

The VAP (Vertical Auto Profile) Expanded Cholesterol Test from Atherotech (Birmingham, Alabama), a cardiodiagnostic company and specialty reference laboratory, steers physicians toward customized drug therapy to fix multiple cholesterol abnormalities rather than just treating elevated LDL cholesterol. Such therapy could reduce cardiovascular event rates by up to 70 percent, according to a study published in the Oct. 15 issue of the American Journal of Cardiology. Physicians at the University of Virginia School of Medicine (Charlottesville, Virginia) found that treatment with multiple cholesterol-lowering medications tailored to the individual patient's cholesterol subclasses can correct many cholesterol subclass abnormalities and has the potential to significantly reduce cardiovascular events. The VAP Expanded Cholesterol Test detects twice the number of patients at risk for heart disease than the routine cholesterol test, the company said. The retrospective analysis of data from 39 patients showed that treatment with multiple drugs altered a number of cholesterol subclasses measured by the VAP Test. Specifically, treatment increased "good" cholesterol subclasses such as HDL, small HDL3, and large HDL2, while significantly reducing disease-causing cholesterol subclasses including IDL, total VLDL, small VLDL3, and triglycerides.

Biophan Technologies (Rochester, New York) said it has successfully tested a method for shielding implanted and interoperative medical devices against interference from magnetic resonance imaging (MRI). The tests, conducted in a 1.5 Tesla MRI machine, prevented most of the radio frequency (RF) energy emitted by the MRI machine from reaching the shielded samples. The RF energy from an MRI is known to be the cause of dangerously high tissue heating and other performance problems in electronic medical devices used in the body, such as implantable pacemakers, cardioverter-defibrillators and neurostimulators, and interventional devices such as guidewires and catheters. Because of those heating problems, the FDA in 1997 issued a contraindication for many of such devices and MRI machines that make it nearly impossible for these individuals to obtain an MRI exam. Biophan said its new technology uses thin-film nanomagnetic and carbon composite coatings, and novel shield designs, each of which can be used individually or together to meet the specific shielding requirements of a wide range of medical devices.

Cardiac Science (Irvine, California) reported receiving FDA 510(k) clearance for an advanced version of its monitoring-defibrillation-pacing electrode pads. The new electrode pads are the disposable element of the company's fully automatic therapeutic bedside monitor, the Powerheart Cardiac Rhythm Module, which provides vigilant monitoring for hospitalized cardiac patients and can deliver lifesaving therapeutic electric defibrillation shocks without human intervention. The Powerheart CRM electrode pads continuously sense patient heart rhythms and deliver defibrillation, when necessary. Smaller than their predecessors, the pads are optimized for 24-hour patient wear and designed to fit a wide range of patient body shapes. Advanced ECG noise-reduction technologies are employed to filter artifacts caused by patient movement during normal activity to enhance arrhythmia detection. The company reports more than 35,000 of its AED products in use today with deployments at many of the world's 100 largest companies.

Cardima (Fremont, California), developer of the Revelation Tx and Revelation Helix microcatheter systems for treating atrial fibrillation (AF), said the FDA has accepted its premarket approval application for the Revelation Tx to treat AF and granted its request for an expedited review. Gabriel Vegh, president and CEO, said, "We plan to continue working with the FDA to assure continued progress in the review process and toward our plan of getting a device to treat AF on the U.S. market." The Revelation Tx is specifically intended to treat patients with paroxysmal AF that is refractory to anti-arrhythmic drugs for which no approved alternative treatment exists. Cardima developed the Revelation Tx linear ablation microcatheter system as a minimally invasive, single-use product.

Corvas International (San Diego, California) began a multicenter Phase II program to investigate the safety and efficacy of recombinant nematode anticoagulant protein c2 (rNAPc2), in patients with acute coronary syndromes. The objective of the program is to evaluate a safe and effective dose of rNAPc2 in moderate to high-risk patients. The program will be conducted in three parts, each of which will investigate rNAPc2 in combination with current anticoagulant and antiplatelet therapies using the low-molecular-weight heparin enoxaparin and aspirin, respectively.

CryoCath Technologies (Montreal, Quebec), which focuses on cryotherapy products to treat cardiovascular disease, submitted to the FDA the fifth and final module in the company's PMA filing plan for the Freezor Cardiac Cryoablation System. The module presents clinical results of the company's 165-patient pivotal FROSTY trial, which was designed to determine Freezor's safety and effectiveness in treating supraventricular tachycardia (SVT). The results of the FROSTY trial are expected to be released upon completion of the FDA review process. "[This] announcement keeps us on plan to launch Freezor into the U.S. marketplace within 12 months," said Steven Arless, president and CEO. Freezor is a single-use, minimally invasive cryoablation catheter specifically designed to create focal lesions to treat high-risk arrhythmias near the AV node where precision is of critical importance. Freezor can reach temperatures at its tip as low as -80 degrees C inside a beating heart.

Estracure (Montreal, Quebec) said it has received approval from Health Canada to initiate a Phase II trial of 17-beta-Estradiol in the prevention of restenosis in patients following percutaneous transluminal coronary angioplasty (PTCA) and stent implantation. The trial, which has just started, will evaluate the safety and efficacy of 17-beta-Estradiol in patients having narrowing or constriction of the coronary arteries caused by atherosclerotic disease. 17-beta-Estradiol will be locally administered in a minimally invasive fashion by bolus infusion during a PTCA procedure. The company said that, contrary to other anti-restenosis drugs presently in clinical evaluation, 17-beta-Estradiol is a non-toxic naturally occurring hormone that has been shown by Estracure's scientific team to have a dual beneficial effect in improving vascular healing and preventing restenosis after angioplasty. The double-blind, placebo-controlled, randomized Phase II study is slated to enroll 360 patients with an atherosclerotic heart condition at six sites in Canada. The primary efficacy endpoint of the Estradiol study will be the angiographic late luminal loss at follow-up.

Guidant (Indianapolis, Indiana) said a premarket approval application was submitted to the FDA for the investigational Multi-Link Vision Coronary Stent System, the company's seventh-generation Multi-Link stent platform for the treatment of coronary artery disease. The Multi-Link system is constructed of a cobalt chromium alloy, enabling the stent to have thinner stent struts and enhanced deliverability while maintaining radial strength and visibility, the company said. Guidant said it plans to use cobalt chromium stents in future drug-eluting stent platforms. Guidant also reported the launch of the Acrobat Off-Pump System, its next-generation stabilization platform for off-pump coronary artery bypass surgery. The company said the Acrobat Off-Pump System is designed to simplify the beating-heart procedure by providing cardiac surgeons with optimal target vessel exposure and stabilization. The fully integrated Acrobat Off-Pump System combines the new Acrobat Stabilizer with Guidant's new Xpose 4 heart access device, designed to be used by surgeons during a beating heart procedure to gently lift and position the heart to expose target coronary vessels without compromising cardiac function. The Acrobat stabilizer is designed to deliver a stable anastomotic (the connecting of graft vessels to the aorta) site with exceptional vessel presentation, making complete coronary revascularization less complex.

Lexicon Genetics (The Woodlands, Texas) said it has discovered a target for the development of drugs to reduce formation of blood clots without increasing bleeding, a common side effect of current therapies such as aspirin that are used to reduce the risk of heart attacks. Lexicon scientists discovered that inhibiting the enzyme, designated LG101, in mice resulted in a 60% reduction in blood clot formation with no observable, undesirable side effects. Lexicon has advanced LG101 into its pharmaceutical division to develop drugs to prevent thrombosis, a major cause of heart attacks and strokes, particularly in patients with atherosclerosis.

MedicalCV (Minneapolis, Minnesota) said the FDA has issued premarket approval (PMA) for two additional sizes of the company's Omnicarbon heart valve, sizes 21 aortic and 25 mitral. With the addition of these two sizes, the Omnicarbon aortic and mitral valves are now available in the U.S. for the vast majority of heart valve replacements, the company said.

Medtronic (Minneapolis, Minnesota) reported the first worldwide implant of the InSync III Marquis implantable cardioverter-defibrillator (ICD) system. This is the company's fifth and most advanced cardiac resynchronization therapy device for heart failure patients, it said. InSync III is a small, (38cc) system that has new atrial monitoring functions that help physicians manage heart failure patients who also have atrial fibrillation, the company said. It also includes new features to provide resynchronization therapy even during episodes of atrial arrhythmia, it said. The first implant took place at the Elisabethinen Clinic (Linz, Austria). Medtronic also reported the limited market release of its S7 Zipper MX Coronary Stent System. The system brings together the first-ever multi-exchange platform and the company's modular stent technology. Medtronic said the system will be launched in the U.S. and globally over the next several months, with a variety of catheter options carrying balloons and coronary stents. The system is designed to facilitate easy, quick exchange of wires and catheters during a coronary angioplasty or stenting procedure, without the physician needing an assistant.

Millennium Pharmaceuticals (Cambridge, Massachusetts) initiated a Phase III trial of Integrilin in patients experiencing an ST-segment elevation myocardial infarction (STEMI), or heart attack. The trial, known as Advance MI (ADdressing the Value of Facilitated ANgioplasty after Combination Therapy or Eptifibatide Monotherapy in Acute Myocardial Infarction), will evaluate the safety and efficacy of Integrilin alone or in combination with reduced-dose tenecteplase, a "clot-busting" treatment followed by percutaneous coronary angioplasty within four hours in heart attack patients. Advance MI will include about 6,000 patients with STEMI at more than 400 sites across North America and Western Europe.

NicOx (Sophia Antipolis, France) said its investigational new drug application was accepted by the FDA for the Phase II testing of NCX 4016, its nitric oxide-donating derivative of aspirin, in development for the treatment and prevention of cardiovascular diseases. The IND will allow expansion of NicOx's broad development program for NCX 4016 in the field of cardiovascular and metabolic diseases, which includes diabetes-related renal and vascular complications, and the treatment of endothelial dysfunction in patients with peripheral vascular disease. In total, the Phase II development program will involve the recruitment of about 120 patients by mid-2003.

Non-Invasive Monitoring Systems (North Bay Village, Florida) released results of a study showing that the acceleration therapeutics AT101 may be a superior method of cardiopulmonary resuscitation when compared to traditional methods. The AT101 is a platform mounted on a hospital-like patient gurney that moves repetitively in a back-and-forth motion from head to foot. CPR administered by the AT101 produced a full recovery, the company said, without adverse events such as rib fractures that can occur with traditional CPR.

Quinton Cardiology Systems (Bothell, Washington) said it began shipping Q-Stress version 3.0 systems using Japanese characters to its Japanese distributor, Nihon Kohden. The companies announced plans in June to jointly develop a version of Q-Stress specifically for the Japanese market. This latest version of Q-Stress displays and prints patient, procedure and clinical information in Kanji characters to increase clinician acceptance and understanding and improve ease of use. Nihon Kohden also will purchase medical treadmills from Quinton to be operated along with the Q-Stress system. Quinton developed integrated Cardiac Stress Testing and has produced medical treadmills since the 1960s.

Response Biomedical (Vancouver, British Columbia) reported positive results from an independent preclinical study of Ramp tests for troponin I and CK-MB, two cardiac markers used in the early detection of heart attack. Both additional Ramp tests demonstrated excellent agreement with the Dade RxL predicate device, a state-of-the-art lab-based analyzer, and showed improvement over Biosite's (San Diego, California) Triage Cardiac Panel, the current market-leading point-of-care diagnostic system for the rapid on-site detection of cardiac markers, Response said. Bill Radvak, president and CEO, said, "Based on the strength of these findings, we have accelerated commercialization timelines and expect to market all three Ramp cardiac tests internationally with a partner before the end of the year. We have also selected clinical trial sites and submitted testing protocols to the FDA, in preparation for entering the U.S. market next year." The Ramp System provides a quantitative measurement of cardiac marker levels in a whole blood sample. Results from the Ramp evaluation are being submitted for publication in a peer-reviewed journal.

Scion Cardio-Vascular (Miami, Florida) received CE marking for its Clo-Sur P.A.D. hemostasis device. The Clo-Sur P.A.D. is a topical, non-invasive device used for rapid control of bleeding associated with catheter removal following a catheterization procedure such as coronary stenting. The Clo-Sur P.A.D. accelerates the hemostasis process in conjunction with placing pressure on the puncture site. Scion CV's Clo-Sur P.A.D technology uses a foam pad featuring the company's proprietary polymer Polyprolate and is water soluble.

St. Jude Medical (St. Paul, Minnesota) launched its 4F Spyglass angiography catheters and Maximum introducer kits for sale in the Japanese market. The St. Jude Medical 4F Spyglass features proprietary braiding technology designed for "outstanding torque response and extra large lumen, which provide excellent flow rates for enhanced angiographic images," the company said. The new 4F Spyglass catheters are available in a range of selective curves. The introducers are designed to create a new dual-layer sheath cannula and dilator configuration to provide improved insertion performance into the vasculature with minimal risk of complications, it said. With 5F and 6F Spyglass catheters already available, St. Jude Medical said it "provides the catheterization laboratory a comprehensive portfolio of angiographic catheters."

Synthetic Blood International (SYBD; Costa Mesa, California) scientists made two Oxycyte presentations to their peers at the annual meeting of the American Association of Pharmaceutical Scientists in Toronto, Ontario. Oxycyte is SYBD's perfluorocarbon- (PFC-) based blood substitute and therapeutic oxygen carrier. The presentations described how Oxycyte is formulated, some physicochemical and biological properties, and show that Oxycyte dissolves and can carry in the blood stream as much oxygen as other PFCs that have been tested in animals and humans. The oxygen and carbon dioxide-carrying capacity of PFCs is the characteristic that makes them useful in blood substitutes. SYBD believes Oxycyte may be useful in treating stroke, heart attack and cancer patients and for use as a blood substitute and in organ preservation.