A third player has entered the drug-eluting stent sector in Europe, though the company claims it was really the second firm to earn the CE mark. While that may be the case, the real question may be the device's speed of entry to U.S. launch. The new entrant is Abbott Laboratories (Abbott Park, Illinois), via its Abbott Vascular Devices (AVD; Redwood City, California) division, which said it has launched its Dexamet (dexamethasone-eluting) stent in Europe, receiving an approval to do so in December.
The company says it actually holds the distinction of being the second player to earn the European honors, beating out Boston Scientific (Natick, Massachusetts), which received European clearance in the latter part of January for its paclitaxel-eluting Taxus system, by about a month. The first-place prize, clearly uncontested, went to Johnson & Johnson's (J&J; New Brunswick, New Jersey) Cordis (Miami Lakes, Florida) unit last April for its Cypher sirolimus-eluting stent.
Abbott said the introduction represented a "significant milestone" for the company and its evolving drug-eluting stent program. Additionally, the company said the Dexamet coronary stent is the first and only approved stent to couple the anti-inflammatory compound, dexamethasone, with phosphorycholine (PC) Technology coating, a biologically inert coating designed to mimic the body's own chemistry and minimize its response to implanted devices. PC Technology is a polymer copy of the outside surface of a red blood cell. The company said that clinical studies suggest that PC Technology acts as a versatile drug-eluting platform, providing a foundation for release of a variety of compounds that address the complex origin of restenosis.
Abbott acquired both the rapid exchange coronary stent platform, also known as the BiodivYsio stent, and the exclusive rights to both the PC Technology coating and use of the Dexament compound, when it purchased the cardiovascular stent business of Biocompatibles International (Farnham, UK) last May for more than $243 million. "This was one of the products that had been in their pipeline," said Stacy Eisen, public affairs director for Abbott. She told Cardiovascular Device Update that the reason many people have not heard about Abbott's drug-eluting stent program is that its focus has been in Europe and other parts of the world and not in the U.S. "We really have not done a lot of publicity about it in the states because it's not a product, at this time, that's going to be launched here," Eisen said
AVD's rapid exchange coronary stent platform was studied in the STRIDE trial. The company said that a prospective, non-randomized European clinical trial successfully demonstrated that dexamethasone on a PC-coated coronary stent has a positive impact on late lumen loss (0.45mm and signifying the amount of tissue obstruction within the vessel that occurs during the healing period) and the occurrence of major adverse cardiac events (MACE) (3.3%) at six-month follow-up when compared to the results of the earlier DISTINCT trial, which evaluated PC-coated stents without a drug coating. With percentage improvements from the STRIDE over DISTINCT of 52.1% and 80.6% respectively for late loss and six-month MACE, the Dexamet stent may offer a new option for improving clinical outcomes, the company believes.
"There is no single solution in the drug-eluting stent arena," said Chip Hance, vice president, vascular devices, for Abbott Laboratories. "Our goal is to develop diversified offerings that provide the physician and patient with highly targeted options for treating coronary artery disease."
Analysts questioned the utility of the product in its current form, especially since a U.S. approval for the system is not on the radar screen. Lawrence Keusch of Goldman Sachs (New York) said that though the STRIDE trial, on which the Dexmet-coated stent's approval was based, showed improvements in safety and effectiveness, "we note that the effectiveness in particular was less pronounced than with J&J's Cypher and Boston Scientific's Taxus." He said his firm continues to believe that Abbott will remain a "relatively minor player in the worldwide stent market until it makes significant progress with its ABT-578 drug-eluting stent program." ABT-578 is a rapamycin analogue that the company is developing that it said has demonstrated encouraging preclinical results. Keusch predicted a U.S. launch for the device in late 2005 or early 2006, placing Abbott way behind most competitors in the sector.
Echoing those sentiments was Larry Haimovitch, president of Haimovitch Medical Technology Consultants (Mill Valley, California) who covers the cardiovascular industry for CDU. "The European market is going very slowly," he said, noting that acquiring the CE mark is "not difficult." The real question is, he said, "how far along are they in the U.S.?"
Whatever the answer, the other players are much farther along in their U.S. endeavors. J&J and Boston Scientific both expect U.S. approvals this year J&J this month or next, Boston Sci before the end of 2003.
Elsewhere in the product pipeline:
Abiomed (Danvers, Massachusetts) reported issuance of a new patent that significantly enhances the company's intellectual property portfolio in the area of active and passive heart wrap devices. Heart wrap devices represent a promising approach to the management and reversal of congestive heart failure, the company said. The new patent describes a passive wrap device that conforms to the shape of the heart to constrain its dilation at diastole, and that may be decreased in size as dilation decreases. Other patents in the Abiomed portfolio cover active wrap devices that consist of a hydraulically actuated artificial myocardium that reinforces the contractions of the natural heart.
Advanced Stent Technologies (AST; Pleasanton, California) said that it has received CE mark approval to market its SLK-View DSX Stent and Delivery System to treat cardiovascular disease at bifurcation points in the coronary vascular system. The SLK-View DSX Stent and Delivery System is a dual-side rapid exchange stent delivery system. AST's first commercial product, the SLK-View Stent and Delivery System, an over-the-wire stent delivery system, received CE mark approval in September 2002.
Angiotech Pharmaceuticals (Vancouver, British Columbia) said it received FDA approval for a new premixed configuration of CoSeal, a fully synthetic vascular sealant. The new premixed CoSeal extends the useable lifespan after mixing to two hours and allows the product to be stored at room temperature. The consistent nature and stability of the new preparation makes it an ideal platform for the introduction of a next-generation, drug-loaded CoSeal, the company said. CoSeal is a biocompatible synthetic surgical sealing agent designed to optimize healing by rapidly sealing tissue surfaces, suture lines and synthetic grafts. It was developed by Cohesion Technologies (Palo Alto, California), a company acquired by Angiotech last month. CoSeal is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage, and is a latex-free, synthetic material that has been proven to be highly biocompatible. It is not made from human blood products, so it carries no risk of viral transmission, Angiotech said. In addition, it is fast-acting and resorbable. Following application, CoSeal forms a flexible seal within seconds, which remains intact at the site of application and is able to withstand arterial pressure.
Armus (Burlingame, California) launched a personal data assistant (PDA)-based preoperative cardiovascular risk calculator at the Society of Thoracic Surgeons (STS) annual meeting in San Diego, California. The company said the Armus Risk Calculator is the first such PDA-based software application available to cardiologists and cardiovascular surgeons. The risk calculator, available in Palm OS, is a pocket-sized, patient-specific preoperative risk analysis device that values operative risk in accordance with national standards. With the calculator, a physician can learn about the patient's predicted mortality, length of stay, morbidity, stroke and other risk values. This can be done in less than a minute, which Armus described as "much faster than requesting a report from a full database system." Cardiologists and cardiovascular surgeons can use the calculated risk values as a decision aid to their clinical expertise in determining the optimum course of action at the point of care. Computations are based on STS risk stratification algorithms.
Bayer Diagnostics (Tarrytown, New York) reported the availability of Advia Centaur BNP (B-type natriuretic peptide) assay, a fully automated test for use in the diagnosis of heart failure (HF), on its automated immunoassay platform, the Advia Centaur Immunoassay System. Recent research has shown that elevated levels of BNP indicate the presence of heart failure, thus providing physicians with an important diagnostic tool in the early detection and treatment of HF. The BNP molecule is physiologically active and measures the direct biologic response to cardiovascular stress providing a direct reflection of the patient's current status. This allows more timely treatment and patient management, the company said. With the automated ADVIA Centaur BNP assay, physicians have access to a test that will allow them to have valuable information in real time, the company said. The BNP assay expands the already comprehensive cardiovascular panel of CK-MB, myoglobin, troponin I and homocysteine offered on the Advia Centaur system, Bayer said. A fully automated test, BNP results are ready in minutes, requiring less hands-on labor while reducing human error associated with manual testing. The BNP assay is currently available in non-regulated countries outside of the U.S. Bayer said it plans to apply for approval with regulated countries and for FDA clearance. Sales will start upon receipt of approvals.
Beyond Genomics (BG; Waltham, Massachusetts) has entered into an agreement with Novartis Pharma (Basel, Switzerland) under which BG will use its Systems Biology approach to analyze samples of patients with cardiovascular disease. Under the program, BG will identify and characterize differences between normal and abnormal patient samples, leading to the discovery of molecular markers to predict, diagnose and monitor the progression of cardiovascular disease. Novartis will provide BG with patient plasma samples for the program and also will provide research funding for the work carried out by BG, including proprietary pattern recognition, clustering, data mining and related bioinformatics analyses. Financial and other terms of the agreement were not disclosed. BG said it is the first company to apply a Systems Biology approach to drug discovery and biomarker identification. By rapidly analyzing clinically relevant samples and integrating data at the gene, protein and metabolite levels using its proprietary technology, the company said it goes beyond genomics to provide new insights into the molecular mechanisms of health and disease.
Boston Scientific (BSX; Natick, Massachusetts) has initiated the launch of its Taxus paclitaxel-eluting stent system in Europe and other international markets. BSX expects to launch the product in the U.S. later this year. Boston Scientific acquired worldwide co-exclusive rights from Angiotech Pharmaceuticals to use paclitaxel to coat its coronary stent products and other vascular and non- vascular products. The company said that the Taxus product will use the Express(2) coronary stent system as its platform. The Express(2) system was launched in the U.S. last September and has been well received, the companies said. The Taxus clinical program is a series of studies designed to collect data on Boston Sci's polymer-based, paclitaxel-eluting stent technology for reducing coronary restenosis after angioplasty and stenting. Prior studies have demonstrated promising results by dramatically reducing restenosis. The polymer on the stent allows for controlled delivery of paclitaxel. The TAXUS I trial confirmed safety and reported zero thrombosis and zero restenosis. The TAXUS II trial studied the treatment of de novo coronary lesions and demonstrated both safety and efficacy using the slow- and moderate-release formulations. Significant improvements were seen for clinical, angiographic and intravascular measures of stent performance compared with the bare control stent. The TAXUS III trial, which studied the treatment of in- stent restenosis, also confirmed safety with no thrombosis. The TAXUS IV trial has completed enrollment and nine-month follow-up is under way. This study is designed to assess the safety and efficacy of a slow-release formulation to support regulatory filings for U.S. product commercialization. The TAXUS V trial has received conditional approval from the FDA to enroll patients and will study a higher-risk patient population than TAXUS IV, including patients with smaller vessels and longer lesions. TAXUS VI is studying patients with complex coronary artery disease and recently completed enrollment. Boston Scientific also has initiated a transitional registry program in a number of countries as part of a limited commercial launch of its TAXUS paclitaxel-eluting stent system.
Cardiac Science (Irvine, California) said that data from a new multicenter study demonstrates that the company's in-hospital Powerheart Cardiac Rhythm Module (CRM) is not only safe and effective, but significantly shortens hospital response time to sudden cardiac arrest (SCA). Because the time to defibrillation is critical to patient survival, the study investigators also concluded that the CRM would significantly improve the outcomes of hospital patients stricken with SCA. The Powerheart CRM continuously monitors a patient's heart, detects the onset of a life-threatening arrhythmia and automatically delivers defibrillation therapy to patients suffering from SCA, without the need for human intervention. The European study, published in the Journal of the American College of Cardiology, monitored 117 patients in 10 European medical centers in Germany, Spain, Italy and Finland. The patients included 51 at risk of cardiac arrest located in special monitoring wards and 66 who were undergoing electrophysiological testing or implantation of cardioverter defibrillators because of suspected or documented ventricular tachyarrhythmias. During a total of 1,240 hours of testing, 1,988 heart rhythm events were documented and 115 of those needed treatment through defibrillation. The mean response time was 14.4 seconds and there were no complications.
Cardima (Fremont, California) has received FDA 510(k) clearance for what is essentially the first half of its two-pronged approach to treatment of atrial fibrillation (AF). The company reported receiving approval of its system to create scars in cardiac tissue during heart surgery using radio frequency (RF) energy. The Cardima Surgical Ablation System provides surgeons with an option to replicate the results of the surgical Maze procedure for treatment of atrial fibrillation (AF), an open-chest, highly invasive treatment only done in conjunction with heart valve repair/ replacement or coronary bypass surgery. On what could be a short-term horizon is the potential approval of the company's Revelation Tx system for creating scars from inside the heart, which Cardima has submitted to the FDA. It was granted expedited review in November 2002. "Revelation Tx will be the primary product," said Ron Bourquin, chief financial officer. But he added that the 510(k) clearance for ablating the outside of the heart is "incremental" and "opens up the surgical application for this particular technology." Bourquin said the company was able to take the less-rigorous 510(k) route because the application applied for specifically replicates the results of the well-established procedure of electrosurgery. Technologies competing to replace the scalpel as the tool of choice for the surgical Maze process include various energy sources that heat or cool the tissue, both attempting to destroy the cells creating the aberrant electrical patterns that cause AF. Using radiofrequency energy to heat the tissue has been practice for many years, and it is a safe, predictable energy source, according to Cardima. "This is a new alternative for the cardiovascular surgeon," Bourquin said, one that has normally been available only to electrophysiologists. Now, he says, the cardiovascular surgeon can do the ablating with the RF tool, rather than a scalpel, in conjunction with other procedures, or even perform it laparoscopically as a stand-alone procedure.
Compumedics (Fridley, Minnesota) said the FDA has granted approval to market the company's portable Somte sleep-cardiology recording system in the U.S. The potential market for Somte in the U.S. is estimated to be of the order of $130 million a year. The company already has been approved to market Somte in Canada, the European Union, Australia and Japan. Somte is a lightweight medical recorder that combines features of diagnostic sleep systems and cardiac recorders. The combination of the technologies addresses the mounting evidence of the correlation between sleep disordered breathing and cardiovascular disease.
CryoLife (Kennesaw, Georgia) said a 21-patient study reported at the Society of Thoracic Surgeons annual meeting last month indicated that CryoLife's BioGlue surgical adhesive may eliminate the need for additional surgery to correct bleeding in patients implanted with ventricular heart-assist devices. According to the study, none of the patients treated with BioGlue, a bovine serum albumin and glutaraldehyde tissue adhesive, required re-operation to stop post-surgical bleeding. In contrast, 25% of patients not treated with BioGlue required additional surgery to correct bleeding. The study was presented by John Blizzard, MD, assistant professor of surgery at Oregon Health Sciences University (Portland, Oregon). The study also showed that the use of BioGlue to mechanically seal the connections between the device and the patient's cardiovascular system was not related to any short- or long-term adverse event. And the use of BioGlue did not increase the difficulty of the VAD removal and transplant procedure, according to the authors.
Daxor (New York) said two new studies conducted at Columbia Presbyterian Medical Center (also New York) were published in the journal Circulation. The first study used the Daxor BVA-100 Blood Volume Analyzer to measure the degree of blood volume expansion in congestive heart failure patients. They compared their findings to an independent physician's estimate of whether the patients had significant expanded blood volume or were normal. In half the heart failure patients, the physicians were not able to detect the abnormal expanded blood volume. The implications of these findings are that blood volume measurement can enable more precise treatment in patients. The second study published in the same journal, involves the treatment of heart failure patients who were found to be anemic by the standard hematocrit test. The authors found that treatment of these patients with erythropoetin significantly improved the symptoms of these patients. Blood volume measurement with the BVA-100 also enabled identification of those patients who were hemodiluted and had increased plasma volume from those patients who were truly anemic and had low red cell volume. Erythropoetin, manufactured by Amgen and Johnson & Johnson, is a restricted drug that increases a patient's red cell volume. The measurement of blood volume has implications for the treatment of patients who may be inappropriately denied treatment because their blood volume is not measured. A third study was published in the November 2002 issue of the Journal of Clinical Anesthesia by Ketan Shevde, MD, Murali Pagala, PhD, et al., from Maimonides Hospital, involving patients undergoing coronary bypass graft surgery. The patients had their blood volume measured with the BVA-100 prior to surgery. Women were found to be significantly more anemic than men and required more blood transfusions. The authors concluded that the increased number of transfusions required for women was related to their low red cell volume prior to surgery.
Eli Lilly and Co. (Indianapolis, Indiana) said the results of the AbESTT (Abciximab in Emergent Stroke Treatment Trial), a study in patients with ischemic stroke, were announced at last month's American Heart Association-sponsored International Stroke Conference in Phoenix, Arizona. The study showed trends suggesting that treating stroke patients with ReoPro (abciximab) might increase recovery of normal or near-normal function and reduce mortality, even when administered up to six hours after the onset of stroke. ReoPro is indicated for prevention of ischemic cardiac complications in high-risk patients undergoing coronary angioplasty. The product was developed by Centocor (Malvern, Pennsylvania). Lilly markets and distributes the product worldwide except in Japan. The companies plan to conduct a Phase III trial to confirm these findings, Lilly said.
Guidant (Indianapolis, Indiana), reported the U.S. availability and launch of the Insignia Entra line of pacemakers. The Entra line complements the existing Insignia family of pacemakers, which was launched worldwide in June 2002, and gives clinicians another option for treating a diverse population of patients. The Insignia Entra pacing system offers comprehensive patient management with 110 seconds of dual channel Electrogram (EGM) storage, the most available on the market today, according to Guidant. EGMs give the physician a recording of the electrical activity occurring within the heart. The increased storage capabilities provide physicians more information for better patient management and diagnostic accuracy.
IDev Technologies (Houston, Texas) said it has received the CE mark for its AKonya Eliminator mechanical thrombectomy device. The company also said that it has been awarded quality certification from BSI, a quality management systems registrar. The AKonya Eliminator mechanical thrombectomy device has been initially indicated for use in declotting of synthetic dialysis grafts. Axial and rotational manipulation of the device's Thrombasket, a woven mesh structure, serves as the declotting procedure mechanism of action. High radial force and vessel compliance can be achieved through user deployment of the Thrombasket, putting additional control back into the hands of the clinician, according to the company. IDev said the receipt of the CE mark positioned it to launch European sales last month through a network of distributors.
Intuitive Surgical (Sunnyvale, California), said it is now promoting use of its robotic da Vinci Surgical System in the U.S. for performing the additional cardiac surgical procedure of totally endoscopic atrial septal defect closure. On the heels of the FDA's November clearance of the da Vinci System for thoracoscopically-assisted cardiotomy procedures such as mitral valve repair, the company said the availability of this additional intracardiac surgical procedure further broadens available use of the da Vinci System, bringing "significant advantages" to hospitals that invest in the da Vinci System and to their patients who benefit from robotic surgical treatment, the company said.
Ischemia Technologies (Denver, Colorado) is hoping that with FDA approval to market its Ischemia Modified Albumin (IMA) test in the U.S., emergency room physicians will have a fourth diagnostic tool to determine if someone who presents with chest pain is suffering or about to suffer a heart attack. ER physicians must make rapid decisions, and currently they have three diagnostic tools to help them determine acute coronary distress (ACS), according to Ischemia Technologies. One tool is the ECG, which measures electrical activity of the heart and according to the company identifies less than half of patients with ACS. A second is biomarkers of cardiac necrosis, or death of heart muscle, including troponin, myoglobin and CK-MB, but these tests may take several hours from the onset of chest pain to determine if someone has had a heart attack, the company said. A third tool is to make decisions based on a physician exam and the patient's history. Ischemia Technologies won 510(k) clearance last month, and the test went on the market the same day the approval was received. IMA is an in vitro test based on the fact that albumin is modified by exposure to ischemic tissue. Albumin binds to certain metals at one end of a molecule, the N-terminus. "The way it works is we take a serum sample, add cobalt, and then test how much cobalt is not bound to the albumin," said President and CEO Peter Crosby. Based on the results, a physician can tell whether or not ischemia exists. The company said the IMA is meant to be used in conjunction with existing diagnostic tests. It also says in product literature for the Albumin Cobalt Binding test that "clinical studies have shown that IMA has high sensitivity for detection of ACS at presentation, and can be as much as four times that of [troponin] and twice that of ECG." The test has been marketed in Europe and Canada since mid-2001 as the Albumin Cobalt Binding test.
Medtronic Physio-Control (Redmond, Washington) reported FDA clearance and commercial market release of its infant/child electrodes for use with automated external defibrillators (AEDs) for children younger than 8 years old. In addition, a new study presented at the recent Society for Critical Care Medicine Critical Care Congress indicates that the new infant/child electrodes provide a wide margin of safety for delivering the appropriate energy for children being resuscitated from sudden cardiac arrest. The new electrodes also allow pediatric patients to benefit from an escalating energy protocol in the AED, meaning that the device first uses a small shock and then uses larger shocks only if the smaller shocks are ineffective. The new infant/child electrodes can be used with Medtronic Physio-Control's biphasic Lifepak 500 AEDs and all Lifepak CR Plus AEDs.
OmniSonics Medical Technologies (Wilmington, Massachusetts) reported the issuance of U.S. atent No. 6,524,251, titled "Ultrasonic Device For Tissue Ablation and Sheath For Use Therewith." The patent has device claims and method of use claims covering an ultrasonic probe or wire and the use of a sheath to direct and focus energy from the ultrasonic probe or wire. OmniSonics also has applied for an international patent to cover the ultrasonic device and method of use. OmniSonics has been developing a series of products to treat vascular occlusive disease based on its OmniWave Technology.
Orbus Medical Technologies (Fort Lauderdale, Florida) said that Michael Kutryk, MD, PhD, an interventional cardiologist at St. Michael's Hospital (Toronto, Ontario), presented his group's latest results on circulating endothelial progenitor cell (EPC) capture technology for improved blood compatibility and biocompatibility of cardiology stents and vascular grafts at the International Symposium on Endovascular Therapy and at the Local Drug Delivery Meeting and Cardiovascular Course on Radiation and Molecular Strategies in January. The EPC capture technology, which involves the immobilization of antibodies that capture EPCs on to blood contacting device surfaces, was developed in collaboration with Orbus. Laboratory results of antibody treated stainless steel and expanded polytetrafluoroethylene surfaces were shown exhibiting an enhanced rate and quantity of EPC binding vs. untreated controls when exposed to isolated human leukocytes and whole blood. At 48 hours, treated stainless-steel Orbus coronary R stents showed a confluent monolayer of endothelium in contrast to the untreated control stent samples which showed evidence of thrombus, disorganized fibrin matrix and discontinuously covering the stent struts. Also presented were early results from serial porcine coronary implants out to 28 days of R stents treated with immobilized antibodies directed toward EPCs. Initial histological examination of the treated 28-day porcine coronary explants showed a marked reduction of organized thrombus and neointimal thickening of the vessel when compared to untreated stainless-steel control stents, the company said.
St. Jude Medical (St. Paul, Minnesota) reported receiving the CE mark for its new Riata single-coil defibrillation lead. Initially released in 2002, the Riata defibrillation lead was previously available in only a dual-coil model. The Riata ICD lead, which the company calls "the thinnest ICD lead on the market," addresses physician preference for a single-coil vs. a dual-coil model. Joseph McCullough, president of St. Jude's international organization, said the Riata lead "is now available in the two configurations most frequently requested by our customers." The Riata's two models are Model 1572, a passive-fixation lead, which affixes within the heart using tines; and Model 1582, an active-fixation lead, which affixes in the heart using an extendable-retractable helix mechanism. The first implant of the Riata single-coil lead was performed Feb. 17 at Queen Mary Hospital in Hong Kong by Dr. Chu-Pak Lau. The implantation proceeded normally and the 67-year-old female patient is doing well, the company said. The Riata lead has been submitted to the FDA for approval.
Synthetic Blood International (SYBD; Costa Mesa, California) said that the company submitted an investigational new drug application (IND) to the FDA in early February for Oxycyte, its perfluorocarbon-based blood substitute and therapeutic oxygen carrier. The IND application informs FDA of the company's intent to start a Phase I safety study with Oxycyte in human subjects. SYBD is developing Oxycyte, which it believes may be useful in treating stroke, heart attack and cancer patients and for use as a blood substitute and in organ preservation, and Fluorovent, a liquid ventilation product that may be useful in treating respiratory disorders in adults and children.
World Heart (Ottawa, Ontario) unveiled the newest configuration of its not-yet-approved HeartSaverVAD (ventricular assist device) last month to the media and analysts at the Toronto Stock Exchange, saying that it believes the new system will "set the standard for the next generation of VADs." The company hosted a conference call to introduce the new device, which is the product of the joint efforts of the HeartSaver I and II programs that combined their research initiatives in August 2002. The device is the next generation to the Novacor device, which is awaiting U.S. and Canadian approval as a destination therapy, though it does have that clearance in Europe. World Heart said it expects both the U.S and Canadian okay for destination therapy with the Novacor sometime this year. The Novacor already is approved as a bridge to heart transplantation in both the U.S. and Canada. During the conference call, the company said the HeartSaver would be unique because it will be both small (about 350 ml) and pulsatile. Like the Novacor, the new device will assume part or all of the heart's pumping action, while leaving the heart in place, and therefore the need to choose between a pulse and a small device is removed. "What's unique about this next generation is that this is a device that is both small and pulsatile," said Jal Jassawala, senior vice president of R&D at World Heart.