Boston Scientific (Natick, Massachusetts) reported the launch of the Chilli II Cooled Ablation Catheter – which it said is the first bi-directional cooled-tip catheter available in the U.S. The company said the Chilli II catheter, which is available immediately for sale, offers physicians the benefits of cooled ablation technology coupled with the proven performance of the Boston Scientific Blazer catheter platform.
Cooled cardiac ablation is a recent advancement in the treatment of ventricular tachycardia (VT) using radio frequency (RF) energy. VT is a serious cardiac arrhythmia characterized by heart rates above 100 beats per minute.
The Boston Scientific Chilli II Cooled Ablation System features a closed-loop cooling system designed to reduce complications often encountered in standard ablation procedures for the treatment of VT. Consistent, continuous fluid circulation cools the catheter tip, reducing coagulum formation and allowing deeper lesions to be created. The closed-loop design of the system eliminates the need to add fluid and monitor flow rates during the procedure, reducing the potential for fluid overload. The Chilli Catheter uses a pump to inject fluid into a catheter lumen to cool the catheter ablation electrode during the delivery of RF energy.
The heat of RF ablation is considered a key drawback, since it limits the amount of energy that can be delivered to the treatment site. In the Chilli Catheter system, circulation of fluid draws heat away from the metal electrode and from the electrode-to-tissue interface, enabling delivery of higher RF power to create wider and deeper lesions.
Boston Scientific acquired the Chilli technology with its $115 million acquisition of Cardiac Pathways (Sunnyvale, California) in August 2001. Cardiac Pathways became part of Boston Scientific’s EP (electrophysiology) division. The company also acquired Cardiac Pathway’s Realtime Position Management (RPM) System, a cardiac mapping and catheter navigation technology, which it has incorporated into its Blazer RPM advanced navigation and ablation catheter. The RPM advanced mapping and navigation provides guidance of the ablation catheter while creating 3-D representations of the heart chambers. By creating visual maps of the heart’s conduction system, that device can assist in the identification of complex tachycardias. The Blazer platform integrates advanced mapping, navigation and electrophysiology recording into one unit, allowing a single operator to perform all of the functions.
Separately, Boston Scientific said an article in the Sept. 14 edition of the Journal of the American Medical Association (JAMA) on the TAXUS V clinical trial found that the company’s Taxus Express2 paclitaxel-eluting stent system “significantly reduces” the risk of artery re-narrowing nine months following angioplasty for patients with complex coronary artery lesions, compared to bare-metal stents.
The company-sponsored study showed that compared with bare-metal stents, implantation of paclitaxel-eluting stents reduced the nine-month rate of target lesion revascularization (TLR), defined as the need for a repeat procedure in the stented area, from 15.7% to 8.6% and target vessel revascularization (TVR) from 17.3% to 12.1%.
The trial – which included the use of multiple stents as well as single stents – originally included 1,172 patients at 66 centers and was designed to assess the safety and efficacy of a paclitaxel-eluting coronary stent in reducing restenosis in de novo lesions 10 mm to 46 mm in length and 2.25 mm to 4 mm in diameter. It had a primary endpoint of nine-month TVR. The analysis population ended up consisting of 1,156 patients, 577 of whom were randomized to receive the paclitaxel-eluting stent and 579 of which were randomized to receive a bare-metal stent.
“The TAXUS V trial investigated the use of paclitaxel-eluting stents in a patient population with more complex lesions than had been previously studied. Angiographic restenosis and target vessel revascularization were significantly reduced in the entire cohort, as well as in those patients with complex disease,” the authors wrote.
In the case of a need for multiple stents, the paclitaxel-eluting device did not fare as well as the bare-metal stent, a trend that is still being investigated. In the study, multiple stents were implanted in 379 patients (planned in 281 and “bail out” for complications or suboptimal results in 98), in whom the mean lesion and stent length were 25.3 mm and 43.9 mm, respectively. In the patients requiring multiple stents, paclitaxel-eluting stent use was associated with an increased incidence of myocardial infarction (MI) at 30 days (8.3% vs. 3.3%), most of which were non-Q-wave MIs.
Elsewhere in the product pipeline:
• Agilent Technologies (Palo Alto, California) has introduced its ChIP-on-chip microarray solution for analyzing activity at regulatory regions of gen-omes. The ChIP (chromatin immunoprecipitation) technology, also known as location analysis, provides insight into key mechanisms of embryonic stem cells and illnesses such as cancer, cardiovascular disease and central nervous system disorders. Agilent said scientists also can use the technology to develop therapies.
• Bioheart (Sunrise, Florida) said the U.S. Patent and Trademark Office has issued a notice of allow-ance regarding two of its patent applications – 10/152,110, titled “Deflectable Microimplant Delivery System” and 10/181,741, titled “Apparatus for Inserting Particles Into Tissue.” The patent applications, acquired by Guidant in June 2003 and licensed back to Bioheart on a co-exclusive basis, cover delivery systems for delivering cells, therapeutic agents, particles and/or other biologics to human tissues. Bioheart is focused on repairing damaged heart muscle with its MyoCell product, a myogenic cell composition made up of adult muscle stem cells called myoblasts.
• Biosite (San Diego) reported that the FDA has granted a Clinical Laboratory Improvements Amendment (CLIA) waiver for its Triage BNP test, which it said would result in “substantially expanding” physicians' access to the test, designed for the diagnosis and assessment of patients with symptoms of heart failure. The Triage BNP Test is a rapid immunoassay blood test that aids in the diagnosis of congestive heart failure, assessment of disease severity and in the risk stratification of patients with acute coronary syndromes. Biosite said the CLIA waiver would expand access to the test among physicians’ offices and decentralized hospital sites of service, allowing more patients to benefit from the 15-minute blood test. “This is a significant competitive advantage for us,” Biosite Chairman and CEO Kim Blickenstaff said, noting that it is “a significant reduction of barriers.” He noted that there are no other companies with CLIA waiver for the BNP test. Biosite secured FDA clearance to market its BNP test in November 2002. It is one of three licensees for the technology from Scios (Fremont, California), which became a subsidiary of Johnson & Johnson (New Brunswick, New Jersey) in 2003. The other two licenses are Roche Diagnostics (Indianapolis) and Bayer Diagnostics (Tarrytown, New York). “Receiving waived status for the Triage BNP test is a significant milestone that nearly triples the number of cardiology, family practice and internal medicine practices with access to BNP testing,” Blickenstaff said. “While approximately 103,000 U.S. physician offices laboratories can perform ... the Triage BNP Test, our efforts will focus on the 55,000 physician practices that most commonly treat heart failure patients.” Previously, use of the test in physicians’ office laboratories was limited to the approximately 18,000 facilities licensed to perform moderately complex tests, Biosite said. In 2004 alone, sales of the Biosite Triage test with just FDA clearance totaled $165 million, Blickenstaff said, giving Biosite about “80% of the market.”
• Biotronik (Lake Oswego, Oregon) reported that the first U.S. implantation of its Lumos DR-T implantable cardioverter defibrillator (ICD) was performed at Loyola University Medical Center (Chicago) by Niraj Varma MD, director of cardiac electrophysiology laboratories at Loyola. The Lumos defibrillator was recently approved by the FDA. Biotronik said it is the first ICD that automatically transmits intracardiac electrograms (IEGMs) via radio frequency (RF) communications and allows the physician to view that vital patient information on a secure website at any time, from anywhere. The IEGM provides beat-by-beat heart rhythm information similar to that of a surface ECG. The company has incorporated that data into its Home Monitoring communications technology. In the instance of a cardiac event such as a ventricular arrhythmia, the wireless system incorporated in the Lumos ICD will automatically and transmit the record to the physician’s office without any patient involvement required. Biotronik’s Home Monitoring system provides automatic, instantaneous transmission of data from both pacemakers and defibrillators to the physician at the time of a cardiac event or change in the implant status.
• CardioTech International (Wilmington, Massachusetts) reported that its wholly owned subsidiary, Gish Biomedical (Rancho Santa Margarita, California), has received FDA clearance for its auto transfusion and cardiotomy reservoir products with GBS (Gish Biocompatible Surface) Coating for the cardiopulmonary surgery market. The GBS Coating is a covalently bonded heparin-based coating composed of heparin and hyaluronic acid, or hyaluronan. Hyaluronan is a hydrophilic biopolymer that occurs naturally in the human body.
• Cook (Bloomington, Indiana) said it would launch the Zenith Renu abdominal aortic aneurysm (AAA) ancillary graft – calling it an “industry-unique device” – following receipt of FDA approval. The company said the Zenith Renu is the “first device for secondary endovascular intervention in the U.S.” Cook said the device is the first designed specifically for secondary endovascular intervention in patients who have received prior endovascular repair of infrarenal abdominal aortic aneurysms. The device, which has successfully treated a “significant” number of AAA patients in Europe and Australia since 2002, will be available to U.S. physicians beginning in September, the company said. Barry Thomas, global leader of the company’s endovascular therapy products division, said that, “Basically, these are in older people. You put in a device, you improve their quality of life and avoid rupture and death.” What the company found in its work in Australia, he said, was that with earlier devices to treat AAA, “they don’t remain in position the length of time that people are surviving and you get migration in the aneurysm, or the aorta continues to expand.” The Zenith Renu device is available in two configurations, a main body extension and a converter. Thomas said that the Renu is “actually a very simple device.” He said the main body extension form is a “short tube that you would put in the current device that would reseal up to the renal arteries.” The converter type “goes all the way down through the current device and goes all the way down through the [iliac].” The Renu AAA Ancillary Graft has been engineered to treat migrations in either Dacron or ePTFE membrane-based aortic endografts, Thomas said.
• EP MedSystems (West Berlin, New Jersey), said that Health Canada has issued a license to allow the company to market its EP-4 Computerized Cardiac Stimulator in that country. EP Medsystems has previously received regulatory approval to market the product in the U.S., Japan and Europe. The company said the EP-4 Computerized Cardiac Stimulator is among the most technologically advanced cardiac stimulators, an essential component of nearly all electrophysiology procedures to diagnose and treat certain cardiac rhythm disorders. It consists of a touch-screen portable PC controlling a two- or four-channel dedicated EP stimulator capable of single-channel, simultaneous and sequential stimulation at programmed output settings. The system is integrated with the company’s EP-WorkMate, as well as other diagnostic technologies used in the monitoring and diagnosis of arrhythmias in the heart.
• Epix Pharmaceuticals (Cambridge, Massachusetts), a developer of pharmaceuticals for MRI, reported the publication of results of the first and second of four MS-325 (gadofosveset trisodium) Phase III clinical trials, MS-325-12 and MS-325-13, in the July and September issues of Radiology. The articles indicate that MS-325, a contrast agent designed specifically for vascular imaging with magnetic resonance angiography (MRA), provides higher quality images of the aortoiliac vessels resulting in better agreement with X-ray angiography, the standard of reference, than non-contrast MRA. MS-325 is being co-developed by Epix and Schering (Berlin).
• Estech (Danville, California) said that David Jayakar MD, chief of cardiac surgery at St. Catherine Hospital (East Chicago, Indiana), successfully completed the first minimally invasive cardiac ablation procedure ever performed using the company’s Cobra Adhere Ablation Catheter System. The surgery was performed on a 42-year-old patient with chronic atrial fibrillation. The device that combines the company’s Cobra radio frequency ablation technology with a suction stabilizer, which Jayakar said allowed him to maintain contact of the device with the epicardial surface of the heart while it was beating; therefore, enabling a minimally invasive approach to the surgical ablation procedure.
• Guidant (Indianapolis) reported that it has enrolled more than 300 patients in its SPIRIT II and SPIRIT III clinical trials, meeting a milestone in the company's license agreement with Novartis Pharma (Basel, Switzerland). Novartis supplies the drug everolimus for use in Guidant’s drug-eluting stent (DES) devices, as well as access to data supporting Guidant’s regulatory filings. Under the terms of the agreement with Novartis, reaching the milestone goal triggers a $60 million in-process R&D charge in 3Q05, of which $40 million will be paid to Novartis in the third quarter. The remaining $20 million will be paid by Dec. 31, 2006, Guidant said. It said that the notified body found no non-conformities and would recommend certification. “We are pleased with our recent progress with the Xience V Everolimus Eluting Coronary Stent System,” said John Capek, PhD, president of Guidant’s Vascular Intervention business. “Enrollment in SPIRIT II and SPIRIT III is progressing well, and successful completion of the audit brings us one step closer to approval to market the Xience V Coronary Stent System in Europe.” SPIRIT II and SPIRIT III are pivotal, single-blind randomized trials evaluating Guidant’s DES system for the treatment of coronary artery disease. They are comparing Xience V, an everolimus-eluting coronary stent system using Guidant's cobalt chromium Multi-Link Vision Coronary Stent System platform, vs. the Taxus Express2 DES from Boston Scientific (Natick, Massachusetts). The company also said that it had concluded “successfully” an inspection of its DES manufacturing and quality systems at its Temecula, California site by its European Notified Body, which also is reviewing the company’s submission for ap-proval to market the Xience V system in Europe. Separately, Guidant reported FDA approval of the Latitude Communicator and secure data storage system. It said these elements represent the final components of the Latitude Patient Management system, which presently can be used with the Contak Renewal 3RF cardiac resynchronization therapy defibrillator (CRT-D) and the Zoom Latitude Programmer. The company said that patients and physicians now have the ability to conduct wireless, automatic device data uploads from a patient’s home. Wireless, automatic data uploads are designed to make the device and patient follow-up process easy for patients and more efficient and effective for physicians, according to Guidant. The Latitude Communicator wirelessly reads implantable device information at times specified by the patient's physician, then transmits the data to a secure Internet server where the physician can access the information anytime, from anywhere. The Communicator also enables Latitude Active Monitoring of the Re-newal 3RF CRT-D device. Latitude Active Monitoring is a daily confirmation of the patient’s device status.
• Inovise Medical (Portland, Oregon) reported the introduction of Audicor 200, its next-generation combination heart sound and electrocardiogram technology intended for the diagnosis of heart failure and acute myocardial infarctions by paramedics. Weighing less than a pound, the portable Audicor 200 is the first diagnostic to help paramedics in the confident diagnosis of shortness-of-breath in patients with subtle signs and symptoms of heart failure. The company said its Audicor technology accurately detects, interprets, and documents the presence of an S3, a highly specific indicator of left ventricular dysfunction, helping lead to the faster diagnosis, appropriate treatment and better clinical outcomes.
• Masimo (Irvine, California) said the FDA has cleared the Masimo SET (Signal Extraction Technology) LNOP Blue sensor, which the company termed “an important milestone for care of cyanotic infants and children.” The clearance of the sensor is for measuring the oxygen saturation of arterial blood (SpO2) in pediatric, infant and neonatal patients with congenital cardiac lesions. Due to what it termed “the unique physiology and critical condition of these patients,” Masimo said “accurate monitoring of SpO2 has not been possible.” Prior to the introduction of the SET LNOP Blue sensor, it said pulse oximeters' inaccuracies were as high as 15% on cyanotic patients. Masimo said its new sensor has an accuracy of 3% in the 80% to 100% oxygen saturation range and accuracy of 4% in the 60% to 80% oxygen saturation range. Peter Cox, MD, clinical director of the pediatric intensive care unit at The Hospital for Sick Children (Toronto), said, “This new sensor has remarkable precision and accurately tracks the arterial oxygen saturation to low levels. In the past, oximeters have been inaccurate in this range.” Masimo said the LNOP Blue sensor is the first sensor to receive accuracy claims for cyanotic infants and children.
• MedicalCV (Minneapolis) said that Dr. Carmelo Otero of Baptist Medical Center (San Antonio) performed three concomitant mitral valve/cardiac tissue ablation procedures with the company’s AtriLaze Surgical Ablation System, completing the minimally invasive procedures through a 4 cm thoracotomy incision and then proceeded to ablate cardiac tissue. Otero said, “This less-invasive technique eliminated the patient sternotomy and associated trauma and provided these patients with a decreased length of hospital stay, making this a promising procedure for patients as well as the hospital.”
• Medtronic (Minneapolis) reported the U.S. introduction of the SelectSecure Lead System, which received approval by the FDA in early August. The company said the Model 3830 lead is the world’s thinnest bipolar lead, adding, “Its lumenless design allows for flexibility and a smaller body size (4.1 Fr) without sacrificing insulation thickness.” Medtronic said the SelectSecure system is the industry’s first lead designed to enable physicians to reach selective sites of the right heart, using a deflectable catheter to allow positioning of the lead in select locations in either the right atrium or ventricle. The SelectSecure pacing lead and SelectSite catheter can be used with pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy (CRT) devices, including CRT-pacemakers and CRT-defibrillators. Medtronic said leads typically have been designed to be placed in the apex of the right ventricle (RV) or right atrial appendage, but recent studies have shown that right ventricle apical pacing may cause mechanical and electrical dyssynchrony, which in turn may increase the patient’s risk of atrial fibrillation and heart failure hospitalizations. Medtronic sponsored a variety of clinical-oriented sessions and other activities during the European Society of Cardiology (ESC) scientific congress in Stockholm, Sweden, in early September. ESC is one of the largest cardiology meetings in the world. Among the activities conducted were scientific presentations about the Endeavor drug-eluting coronary stent program, the CARE-HF heart failure trial and the Reveal Plus insertable loop recorder. Twelve-month results from the ENDEAVOR I clinical trial, published in the European medical journal EuroIntervention, were available at ESC.
• MIV Therapeutics (MIVT; Vancouver, British Columbia), a developer of biocompatible stent coatings and drug-delivery technologies for the treatment of cardiovascular disease, said that interim results of a long-term animal study of its ultra-thin hydroxyapatite (HAp) coating would be featured at this year’s 17th annual Transcatheter Cardiovascular Therapeutics conference in Washington this month. Making the presentation will be Dr. Greg Kaluza, scientific director of the Center for Research in Cardiovascular Interventions at The Methodist Hospital Research Institute (Houston), who directed the independent pre-clinical study of MIVT’s passive stent coatings. MIVT developed its HAp coating technologies under a collaborative research agreement with the University of British Columbia (also Vancouver).
• Olympus (Melville, New York) said it received FDA clearance for its C-reactive protein (CRP) latex assay as an independent cardiac risk marker. It said that measurement of CRP “can have a role in the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.” The company said that “high sensitive application measurements, when used in conjunction with traditional clinical laboratory evaluations, may be useful as an independent marker of prognosis for recurrent events in patients with either stable coronary disease or acute coronary syndromes.” The Olympus CRP Latex assay offers three applications covering a variety of measuring ranges to quantify C-reactive protein in human serum, including normal (5 mg/L to 170 mg/L), sensitive (cardiac) (0.5 mg/L to 20 mg/L) and highly sensitive (neonatal) (0.05 mg/L to 2.00 mg/L). The assay is designed for use on Olympus’ full line of chemistry-immuno analyzers, including the AU400/400e, AU600, AU640/640e, AU2700 and AU5400.
• Radiant Medical (Redwood City, California) said the first patient has been enrolled in COOL MI II, an international clinical study designed to demonstrate that lowering a patient’s body temperature during a heart attack will reduce the subsequent damage to the heart. The procedure was carried out on a patient at William Beaumont Hospital (Royal Oak, Michigan), using Radiant’s Reprieve Endovascular Temperature Therapy System to rapidly cool the patient to 89.6 degrees F. “By rapidly cooling the heart we hope to preserve the heart muscle, and thereby improve long-term heart function and patient survival,” said Dr. Maher Rabah, who together with Dr. Simon Dixon performed the first case. “We were very pleased with the ease and speed of the procedure, and with how well the patient tolerated the reduction in temperature.” The COOL MI II study has been designed to show that earlier, faster and deeper cooling results in a clinically significant reduction in heart damage. Ken Hayes, president and CEO of Radiant Medical, said the new Reprieve System cools over three times faster than the original technology, reaching target temperature in less than 20 minutes. The COOL MI II study will enroll patients at 30 international sites over the next two years.
• Siemens Medical Solutions (Malvern, Pennsylvania) said that more than 80% of clinical research published to date on cardiac computed tomography (CT) has involved Siemens CT technology, with three 64-slice studies published in peer-reviewed, internationally renowned medical journals. Siemens bills its Somatom Sensation 64 CT system as “the most successful” 64-slice CT system, with more than 350 installations worldwide. More than 40% of these installations include the Somatom Sensation Cardiac 64, which specializes in the diagnosis and treatment of cardiovascular disease. In the published studies, results derived from 64-slice CT were compared to traditional invasive catheter angiography and intravascular ultrasound. The authors of all the articles highlight the Somatom Sensation 64’s excellent image quality with an isotropic spatial resolution of below 0.4 mm in all routine and cardiac scan modes, enabling a new level of clinical confidence, the company said. Using z-Sharp Technology and a rotation speed of 0.33 seconds, the system supplies high quantitative and qualitative diagnostic accuracy for the non-invasive assessment of coronary artery stenoses, coronary plaque composition and plaque burden in a broad spectrum of patients.
• Spectranetics (Colorado Springs, Colorado) reported receiving FDA 510(k) clearance for its CLiRpath 2.5 Turbo Catheter to treat total occlusions in the superficial femoral artery (SFA), and has begun marketing the product. The company calls the 2.5 Turbo the latest in its CLiRpath (Cool Laser Revascularization for Peripheral Artery Therapy) line of excimer laser catheters, ranging in diameter from 0.9 mm to 2.5 mm. The catheters are designed for treating blockages in the peripheral vasculature, and the 2.5 Turbo features an increased number of laser fibers to create more energy and faster penetration rate to more efficiently ablate larger lumens in the SFA and popliteal arteries; a “continuous on” lasing train, whereas the 2.5 catheter has a 10-second on feature enabling shorter procedure times and reduce radiation exposure; and hydrophilic coating to allow for smoother advancement through tight lesions and an easier transition over the aortic bifurcation. CLiRpath provides an alternative to amputation, the company said. Spectranetics manufactures single-use medical devices for minimally invasive surgical procedures within the cardiovascular system in conjunction with its excimer laser system. Separately, Spectranetics said it will extend features of the recently launched 2.5 Turbo product to its entire CLiRpath product line used for clearing arterial blockages in the leg. Spectranetics has received 510(k) clearance from the FDA for the “continuous on” lasing train to be added to the CliRpath product line. The company said it plans to launch the expanded CliRpath Turbo product line within the next 90 days, allowing for required software upgrades to be completed for its customers. Spectranetics said many patients suffering from peripheral vascular disease and critical limb ischemia have total occlusions that cannot be crossed with standard guidewires, and have so few treatment options that surgery – either bypass or limb amputation – is nearly inevitable. It said its CLiRpath (Cool Laser Revascularization for Peripheral Artery Therapy) product line “provides an alternative in the fight against amputation.”
• St. Jude Medical (St. Paul, Minnesota) said the results of a multi-center clinical study of its Epicor high-intensity focused ultrasound (HIFU) cardiac tissue ablation device have been published in the September issue of the Journal of Thoracic and Cardiovascular Surgery. The Epicor technology allows an ablation device to be placed on the outside of a beating heart and deliver high-intensity focused ultrasound energy across the wall of the heart to create precise and complete lines of cardiac tissue ablation. The Epicor Cardiac Ablation System includes the UltraCinch ablation device and the UltraWand handheld ablation device. In all, 103 patients were enrolled in the multi-center study from September 2002 through February 2004. The study showed that at six-month follow-up, 85% of patients in the study group remained free from atrial fibrillation (80% in patients with permanent atrial fibrillation, 88% in patients who received an additional mitral line, and 100% in patients with paroxysmal atrial fibrillation). Jane Song, president of St. Jude’s Atrial Fibrillation Division, said the study “provides valuable insight into HIFU technology and the Epicor Cardiac Ablation System’s potential.”
• vasamed (Minneapolis), a developer of non-invasive, hemodynamic assessment technology, said it has made initial customer shipments worldwide of its new AcQtrac Impedance Cardiography (ICG) Noninvasive Hemodynamic Assessment System. The company said AcQtrac ICG is “the newest generation of noninvasive solutions that assess cardiovascular functioning and provide physicians with rapid, reliable results.” The AcQtrac ICG “is unique in its class since it provides a waveform ‘image’ of the heart that serves as a diagnostic aid and helpful tool in guiding drug therapy management,” said Paulita LaPlante, vasamed president.
• Vascular Solutions (Minneapolis) reported 510(k) clearance from the FDA for the Pronto-Short extraction catheter and the subsequent immediate launch of the product through its direct U.S. sales force. The Pronto-Short is a product line extension of the Pronto extraction catheter designed to remove inter-arterial thrombus through a proprietary catheter using syringe aspiration. It is designed for use in de-clotting arterial-venous grafts and fistulas that are used in hemodialysis procedures. CEO Howard Root said, “Due to their frequent use, dialysis grafts and fistulas are prone to clotting, with each patient requiring on average one de-clot procedure each year. Since these grafts and fistulas are relatively large and since direct percutaneous access is used to perform the de-clot procedure, a larger and shorter version of the original Pronto catheter is required for this procedure.” He said the Pronto-Short combines these features with the company’s Silva tip to offer “a very simple, unique and low-cost approach to removing thrombus in A-V grafts and fistulas.” The company estimates the U.S. market opportunity addressed by the Pronto-Short to be about $100 million annually.
• ViaCell (Cambridge, Massachusetts), a clinical-stage biotechnology company, reported the publication of results of a preclinical study demonstrating that administration of stem cells sourced from umbilical cord blood and using ViaCell’s process significantly improved heart function in an in vivo model of myocardial infarction. The results of the preclinical study, sponsored by ViaCell and conducted in association with the Toronto General Research Institute at Toronto General Hospital, have been published in the Aug. 30 Cardiovascular Surgery Supplement of Circulation: Journal of the American Heart Association. As described in the publication, four weeks after cell transplantation, engrafted human unrestricted somatic stem cells were detected in the infarct region of the heart, and the implanted cells were shown to improve regional perfusion and wall motion of the infarct region compared to controls. In addition, ejection fraction increased in the transplant group compared to a decrease in controls.