In-stent restenosis is a major issue when it comes to percutaneous coronary intervention of coronary vessels, often requiring patients to undergo repeat procedures, or more invasive surgery. And this is an even more vexing problem when it comes to occluded vessels of the leg.
"You can try balloon angioplasty," Will McGuire, COO of Spectranetics (Colorado Springs, Colorado), told Cardiovascular Device Update. "But data will tell you the success rate of this is fairly low."
Spectranetics is banking on a technique combining its Turbo elite laser catheters in combination with its recently FDA-cleared Turbo-Booster. The Turbo-Booster functions as a guiding catheter facilitating directed ablation of blockages in the main arteries at or above the knee. The Turbo-Booster, combined with Turbo elite laser catheters, enables removal of large amounts of plaque material within the superficial femoral artery (SFA) and popliteal arteries, Spectranetics says, and the company has just started a prospective registry of 100 patients, the PATENT trial, at up to 10 sites in Germany, with enrollment of the first patient.
The company submitted its 510(k) application to the FDA for its Turbo-Booster in May. That came just two months after the company said it stopped its CELLO trial, with the FDA's approval, after completing about three quarters of enrollment. The trial was stopped, the company told CDU at the time, because its preliminary data was strong enough to meet the endpoints. It then received FDA clearance of the Turbo-Booster in July.
So why the additional trial?
"We don't have [FDA] clearance to treat in-stent restenosis using both of the technologies," McGuire said — meaning both the Turbo elite laser and the Turbo-Booster. "In Europe we have a pretty broad clearance. But the PATENT trial will allow us to collect clinical data in a controlled manner. We would like to get a similar indication in the states."
Data derived from the trial will be able to give the company more ammunition to win FDA approval.
The trial will assess patency with the use of duplex ultrasound at various intervals up to 12 months following the procedure. It will also follow patients for up to one year as a measure to see if there are any adverse affects. PATENT is expected to be completed within 30 months, according to the company.
Spectranetics said that in the first procedure a patient with four local lesions was treated with the Turbo-Booster and Turbo elite 2.0 mm catheters in a 20 cm long SFA.
"The initial result from this Spectranetics device looks very promising, as the new features allow for ablation of more tissue in larger vessels," said Andrej Schmidt, MD, of the University of Leipzig-Heart Center.
"In-stent restenosis in a superficial femoral artery represents one of the most challenging procedures in our practice, he said. "The current standard of care, such as repeat balloon angioplasty, does not have good results as these lesions tend to reoccur. We are very excited with the start of this study in Germany, and we look forward to examining the mid- and long-term results of this new therapy."
If successful, the company could have the first procedure to deal with in-stent restenosis in this sector.
John Schulte, president/CEO of Spectranetics, in a company statement, said, "We believe that in-stent restenosis in the superficial femoral artery may represent 25% to 35% of all above-the-knee procedures." And he expressed hope that the trial will help offer help where "there is currently not a good solution for this challenging lesion subset."
Spectranetics laser systems are used to ablate lesions into tiny particles that are absorbed into the bloodstream. The company's disposable catheters use high-energy "cool" ultraviolet light to vaporize arterial blockages in the legs and heart, as well as scar tissue encapsulating pacing and defibrillation leads.
Elsewhere in the product pipeline:
- Abbott (Abbott Park, Illinois) reported enrollment of the first patient in HERCULES (Herculink Elite Cobalt Chromium Renal Stent Trial to Demonstrate Efficacy and Safety), a U.S. clinical trial designed to evaluate the safety and effectiveness of the investigational RX Herculink Elite renal stent system to treat patients with renal artery stenosis (RAS), a condition characterized by fatty plaque buildup in the kidney arteries that can lead to high blood pressure. The RX Herculink Elite is an .014-inch rapid-exchange (single-operator) renal stent system made of cobalt chromium, a material that is stronger and easier to see under X-ray than stainless steel. To qualify for the HERCULES study, patients must have uncontrolled hypertension that is not responding to treatment with at least two blood pressure medications, and must have at least 60% stenosis or blockage in a renal artery as measured by visual X-ray angiography. Abbott Vascular, a division of Abbott, is a vascular care business.
- Aloka (Wallingford, Connecticut) reported the introduction of two ultrasound systems with dedicated platforms for advanced cardiac and vascular imaging, the Alpha 10 and Alpha 7. The Alpha 10 incorporates all of the standard cardiovascular features such as stress echo, TDI/strain, TEE transducers, full reporting capabilities, and DICOM networking. The Alpha 7 provides image quality for mid-level and office based imaging. It offers a suite of cardiovascular capabilities in a compact chassis for those facilities where space is at a premium. Aloka specializes in ultrasound equipment.
- Boston Scientific (Natick, Massachusetts) released data reflecting experience from the first 15,000 patients monitored wirelessly on the Latitude patient management system. The Latitude can detect clinical events between scheduled follow-up visits and then send the clinical event data directly to physicians. Virtually all Boston Scientific ICD and CRT-D patients are eligible to be enrolled on Latitude. To date, more than 60,000 patients are enrolled on the system at more than 1,300 clinics across the U.S. An optional component to the Latitude is a wireless weight scale and blood pressure cuff, which is aligned with the ACC/AHA physician society guidelines that recommend monitoring weight and blood pressure. Latitude also offers custom views with clinical data to both the implanting and health care following physicians. Boston Scientific makes interventional medical products.
- Cardica (Redwood City, California) reported that two independent groups of cardiothoracic surgeons performed advanced minimally-invasive, closed-chest bypass procedures using Cardica's C-Port Flex A Anastomosis system and Intuitive Surgical's (Sunnyvale, California) da Vinci robot. The C-Port Flex A system, an automated flexible shaft device, automates the attachment, or anastomosis, of a blood vessel graft to a coronary artery during bypass surgery. During minimally-invasive, closed-chest bypass procedures the surgeon guides the da Vinci Surgical System to perform precise movements through fingertip-size incisions in the chest area, similar to the procedures for minimally invasive abdominal surgery. To ensure the highest level of safety for the patient, the cardiothoracic surgeon creates an additional safety port insertion for extreme instances in which the surgeon needs direct and sudden access to the heart. The Flex A eliminates a bottleneck to the broad adoption of minimally invasive bypass procedures as it replaces hand-sewn sutures with an automated connection of the vessel graft to the coronary artery, which can be performed consistently, quickly and reliably. This connection, called an anastomosis, is often considered the most critical step during bypass surgery. Cardica makes automated anastomosis systems for coronary artery bypass graft surgery.
- CardioDynamics (San Diego) said it has received FDA market approval for the new ICG clinical parameters and electronic medical record (EMR) interface capability for its BioZ Dx system. The BioZ Dx is the product of a co-development partnership between the company and Philips Medical systems. The new ICG clinical parameters include total arterial compliance (TAC) and Q-C time interval (QC). TAC allows the assessment of peripheral artery elasticity, an early marker of peripheral artery and cardiovascular disease. Monitoring TAC may allow earlier identification of cardiovascular risk not apparent with standard tools, including blood pressure assessment, and earlier therapeutic intervention which has been proven to delay or prevent cardiovascular disease progression. QC has been demonstrated to offer enhanced assessment of cardiac contractility. CardioDynamics specializes in impedance cardiography technology.
- Cook Medical (Bloomington, Indiana) has received FDA approval to begin its three-center U.S. Phase I clinical trial designed to evaluate the Cook Zenith dissection endovascular system for the treatment of Type B thoracic aortic dissections. The system is intended for use in the endovascular treatment of descending thoracic aortic dissection in patients with anatomies amenable to endovascular repair. The device's Z-stent exerts a minimal radial force that allows gradual apposition of the dissection septum and re-expansion of the true lumen. Endovascular aortic repair (EVAR) eliminates the need for highly invasive open surgery. Rather than opening the chest cavity and clamping off the aorta to surgically implant a graft to treat the damaged section of the aorta, physicians insert a catheter loaded with a self-expanding, fabric covered stent-graft through a surgical opening in the femoral artery. The catheter is guided through the patient's blood vessels under fluoroscopy until the device is positioned across the weakened section of the aorta. The stent-graft expands upon deployment from the catheter to form a continuous tube through the aorta that carries the blood and reduces pressure on the damaged vessel, restoring normal blood flow. The uncovered Zenith Dissection Stent may be used to expand the true lumen in the distal thoracic aorta where preservation of the side branch artery blood flow is critical. Cook Medical makes interventional devices.
- FlowCardia (Sunnyvale, California) reported completing enrollment into the Peripheral Approach To Recanalization In Occluded Totals (PATRIOT) study. The study was designed to assess the safety and efficacy of the peripheral line of Crosser catheters in lower limb chronic total occlusions (CTOs). The Crosser is a rapid exchange catheter delivered over standard .014" and .018" guidewires to the site of a CTO. Using high frequency vibration, the Crosser is designed to safely and quickly cross CTOs allowing for subsequent debulking, balloon angioplasty and stent placement. FlowCardia is a privately held medical device company that makes CTO recanalization systems.
- HemoBioTech (Dallas) said it has gathered results from a pre-clinical study of its HemoTech blood substitute product in patients undergoing percutaneous coronary intervention (PCI) through angioplasty and stent implantation. In the ex vivo human study, HemoTech showed markedly reduced platelet aggregation, one of the major complications associated with PCI procedures. HemoTech also demonstrated the potential for preventing restenosis (narrowing of the artery), another potentially dangerous side effect of PCI. HemoTech is composed of bovine hemoglobin that is chemically modified with adenosine triphosphate, adenosine, and glutathione. In addition to carrying oxygen through the bloodstream, HemoTech also induces erythropoiesis (red blood cell production). Based on preclinical studies and an initial foreign human clinical study, the company believes that HemoTech, due to its novel chemical composition, may significantly diminish or even eliminate the intrinsic toxicities that have plagued other attempts at developing blood substitutes. HemoBioTech is focused on developing a commercial substitute for human blood.
- ImaRx Therapeutics (Tucson, Arizona) reported receiving approval from the data and safety monitoring board (DSMB) to proceed with the second dose cohort in its TUCSON (Transcranial Ultrasound in Clinical SONoLysis) Phase I/II dose escalation study evaluating SonoLysis + tPA therapy in patients with acute ischemic stroke. The ImaRx SonoLysis program is focused on the development of product candidates that involve the administration of its MRX-801 microbubbles and ultrasound to break up blood clots and restore blood flow to oxygen-deprived tissues with or without a thrombolytic drug. The sub-micron size of MRX-801 microbubbles may allow them to penetrate a blood clot, so that when ultrasound is applied their expansion and contraction, or cavitation, can break the clot into very small particles. ImaRx is conducting an ongoing Phase I/II multinational clinical trial evaluating its SonoLysis + tPA therapy to treat patients with acute ischemic stroke. ImaRx makes therapies for vascular disorders.
- Lumen Biomedical (Plymouth, Minnesota) reported FDA clearance from the FDA to market two additional sizes of their Xtract aspiration catheter in the U.S. The Xtract, which is indicated for use in the removal of soft, fresh thrombi and emboli from arteries in the body, is now available in two larger sizes (5 Fr and 5.8 Fr). The smaller catheter size (4.2Fr) was granted FDA clearance June 2006. Clots can restrict or interrupt blood flow within an artery, creating severe complications in patients. Thromboses events can be caused by physiological conditions or from interventional procedures themselves, one such complication being stent thrombosis. The Xtract is designed to remove fresh, soft emboli or thrombi from the arterial system. It is a single-use, 0.014" guidewire compatible, temporary intravascular extraction and aspiration catheter system. The catheter features a braided shaft for responsive delivery and kink resistance, a large aspiration lumen, and a soft curved tip to negotiate obstructions and provide directional suction. Lumen Biomedical makes products that can be used in any anatomical area where embolic protection or emboli removal is required.
- MedicalCV (Minneapolis) said that Crayton Pruitt, MD, a pioneer in the minimally-invasive surgical (MIS) treatment of atrial fibrillation (AF), completed the first closed-chest, beating heart cardiac ablation using the Solar surgical ablation system. The ATRILAZE Surgical Ablation System has been cleared for ablationof soft tissue, including cardiac tissue, and the SOLAR Surgical Ablation System has obtained clearance for the ablation of soft tissue. Bolling, a professor of surgery and the Gayle Halperin Kahn Professor of Integrative Medicine at the University of Michigan Cardiovascular Center and Banner Baywood Heart Hospital, said, "I have now used the SOLAR System to create an automated, circumferential box lesion on the beating heart and the ATRILAZE System to complete the remaining lesion sets of the Cox-Maze III-b procedure," said Bolling, who is also the Director of the Mitral Valve Clinic at the Cardiovascular Center. "Marc Flores, president/CEO of MedicalCV, said, "To date, our technology has been utilized in 57 concomitant ablations and seven stand-alone robotic ablation procedures, demonstrating that we compete in both the open and minimally invasive markets... . [O]ur intent is to aggressively pursue these two market opportunities." The Company's core products are the SOLAR and ATRILAZE Surgical Ablation Systems for use in soft and cardiac tissue ablation procedures, respectively. The ATRILAZE System has been utilized in concomitant open-heart and, by some cardiothoracic surgeons, in minimally invasive cardiac surgery procedures. The SOLAR System has been used in concomitant ablation procedures on both stopped and beating hearts.
- Microlife USA (Dunedin, Florida) reported the launch of the Microlife blood pressure monitoring and Peak Flow/FEV1 monitoring drivers as a part of Microsoft Corp.'s newly launched consumer health platform, Microsoft HealthVault, to provide consumers with a new way to monitor and manage their health at home. The online environment allows consumers to search and connect people with their stored health information, putting them in greater control of their health and wellness. Microlife's contribution includes the manufacture and support of clinically validated, hospital accurate blood pressure monitors and digital electronic Peak Flow/FEV1 meters. The Microlife application allows patients to upload the stored measurement readings from their compatible Microlife blood pressure monitor to the HealthVault site where they can be reviewed by their physician or other authorized healthcare provider. Microlife makes medical diagnostic equipment for home and institutional use, with a focus on blood pressure monitors, digital and infrared thermometers and peak flow meters.
- NovoSci (The Woodlands, Texas) said that it has received FDA clearance to market its new D-Line brand of dual lumen, short-term hemodialysis catheters. They are first in a series of new product acquisitions for the company and part of its strategy to expand its offering of single-use, disposable medical products. The D-Line hemodialysis catheters are used to access the patient's vein and to route the blood to the machine. The D-Line catheters are made from polyurethane that resists kinks, making them easier for the clinician to use. NovoSci makes single-use disposable medical products.
- OBS Medical (Indianapolis) reported clearance to market its next generation patient deterioration early warning system (Visensia) in the U.S. Formerly known as BioSign, the Visensia technology evaluates up to five vital signs: heart rate, respiration rate, body temperature, oxygen saturation and blood pressure - and fuses this data into a single measurable index, the Visensia index. The Visensia can allow hospital clinical staff to evaluate patient deterioration from central locations (department central station or hospital-wide patient safety response center). In addition, the new system will be able to integrate vital signs from periodic monitoring environments (such as medical/surgical floors and telemetry floors) to create the first-ever hospital-wide patient deterioration early warning system.
- OmniSonics Medical Technologies (Wilmington, Massachusetts), a developer of devices for use in the treatment of vascular disease, reported receiving FDA clearance for its catheter-based OmniWave endovascular system for the infusion of physician specified fluids, including thrombolytics, and for the removal of thrombus in the peripheral vasculature. Based on OmniWave technology, the system is "the first minimally invasive catheter-based technology that delivers low-power, transverse ultrasonic energy to remove thrombus quickly, safely, and effectively," according to the company. Thrombus occurs in a number of conditions including deep vein thrombosis (DVT), when large veins are blocked and acute limb ischemia, when there is a sudden decrease of blood flow to the arteries of a limb. DVT affects approximately 2 million people in the U.S. every year, and acute limb ischemia affects more than 250,000 people in the U.S. every year. Richard Ganz, president/CEO of OmniSonics, said, "We believe that OmniWave Technology has the potential to be used in a wide range of vascular applications."
- Pervasis Therapeutics (Cambridge, Massachusetts) reported the publication of new animal data for its Vascugel product under investigation to aid in healing, function, and remodeling of traumatized veins and arteries. The study suggested that Vascugel, a biologically active matrix of endothelial cells that is placed directly on damaged blood vessels to stimulate natural repair and regeneration, was instrumental in increasing the diameter of injured vasculature, and reduced vascular narrowing, in tests utilizing a porcine model of arteriovenous (AV) grafts. Vascugel is an allogeneic cell therapy product for enhancing repair and preventing clinical failure of vascular surgery and intervention. Pervasis Therapeutics makes regenerative cell-based therapies and devices.
- Rochester Medical (Stewartville, Minnesota) reported the publication of results from a clinical study which demonstrates the effectiveness of the company's proprietary infection control technology. The study, presented in the Annals of Internal Medicine concluded nitrofurazone-impregnated urinary catheters reduced the incidence of catheter-associated bacteriuria and funguria in adult trauma patients, reducing the need to change or prescribe new antimicrobial therapy. The nitrofurazone-impregnated urinary catheters used in the study were manufactured by Rochester Medical. Rochester Medical makes disposable medical catheters and devices for urological and continence care applications.
- Stereotaxis (St. Louis) said that a presentation by Xu Chen, MD, of the Rigshospitalet at the University of Copenhagen, reported a 93% acute success rate in patients treated for atrial fibrillation (AF) with the Niobe magnetic navigation system. Chen's presentation focused on his use of catheter ablation to treat 42 patients with AF. In all cases, Chen guided the catheters with the Niobe magnetic navigation system, controlled from his remote station adjacent to the procedure room. In 93% of these cases the pulmonary veins were fully isolated from the left atrium, eliminating the main cause of the arrhythmia. Stereotaxis makes cardiology instrument control systems for use in the interventional surgical suite.
- Transoma Medical (St. Paul, Minnesota) reported receiving FDA clearance for its Sleuth electrocardiogram monitoring system, the company saying that the Sleuth is the first wireless, implantable heart monitor for human applications. The Sleuth monitors heart activity to provide accurate, timely diagnostic data for evaluating cardiac arrhythmias and other serious conditions, which often lead to infrequent, unexplained syncope. The instrumentation includes a high-definition implantable loop recorder, a personal diagnostic manager, and a monitoring center. Transoma makes implantable wireless monitoring systems for biomedical research.
- Verax Biomedical (Worcester, Massachusetts) reported FDA clearance for its platelet PGD test system. The company said that the system cuts the detection time for bacterial contamination in leukocyte reduced apheresis platelets to about 30 minutes. To combat the risk of bacterial contamination, the American Association of Blood Banks (AABB), requires all of its members to detect and limit contamination in platelets. Recent articles published in Transfusion, the journal of the AABB, indicate that current culture testing methods fail to detect half of the contaminated units in the U.S. inventory and false negative results associated with this testing have resulted in 26 documented septic transfusion reactions including five fatalities since testing began in 2004. The platelet PGD test is designed to allow testing after platelets have entered the inventory and offers clinicians the opportunity to detect contaminated units that slip past current testing methodologies. Verax makes rapid tests for detecting bacterial contaminants in blood cells and tissue.
- Vermillion (Fremont, California) reported the publication of research that details how a protein biomarker called beta-2 microglobulin may aid in the diagnosis of peripheral artery disease (PAD). The findings, which suggest beta-2 microglobulin is elevated in patients with PAD and that the level of the protein is correlated with the severity of the disease, will be published in the September issue of Circulation. Vermillion said it intends to develop a blood test for the diagnosis of PAD and the company's development program is aimed at identifying and commercializing a panel of new biomarkers, which includes the newly discovered role of beta-2 microglobulin. Beta-2 microglobulin levels were correlated with the severity of disease, as determined by ankle blood pressures, and by the distance patients could walk on a treadmill. Beta 2microglobulin was an independent predictor, even after taking into consideration traditional risk factors such as cholesterol, diabetes, and age. Vermillion makes diagnostic programs in oncology/hematology, cardiology and women's health with an initial focus in ovarian cancer.
- W. L. Gore & Associates (Flagstaff, Arizona) said that it has received approval from the FDA to market its Gore Viabahn Endoprosthesis with Heparin Bioactive Surface for vascular bypass in the superficial femoral artery (SFA). The Gore Viabahn combines Gore's heparin surface treatment with the Gore Viabahn Endoprosthesis for treatment of peripheral vascular disease in the SFA. The Viabahn uses end-point covalent bonding to keep the heparin anchored to the endoprosthesis surface over time. The end-point surface attachment technology is designed to preserve the heparin bioactive sites such that they remain free to interact with the blood without being consumed. The Viabahn is constructed with a durable, reinforced, biocompatible, expanded polytetrafluoroethylene (ePTFE) liner attached to an external nitinol stent structure.
- W. L. Gore & also reported the availability of its Preclude vessel guard, calling it the first non-biological membrane indicated as a cover for vessels following anterior vertebral surgery. This advanced biomaterial reduces the risk of potential vascular injury by providing a permanent and visible plane of dissection around the vasculature to facilitate anterior revision surgery. Gore Preclude enables vasculature management in patients having undergone anterior spinal surgery for degenerative disc disease, including artificial disc replacement. Scarring around the aorta, vena cava and iliac vessels complicates revising, repositioning or removing a disc prosthesis. The vessel guard has a three-layer construction with two outer layers consisting of a tight expanded polytetrafluoroethylene microstructure preventing penetration by fibroblasts, and thus minimizing vascular tissue attachment to the device, allowing safer anterior revision. The Gore medical products division makes vascular grafts, endovascular and interventional devices, surgical patches and meshes for hernia repair, and sutures for use in vascular, cardiac, general surgery and orthopedic procedures.
- World Heart (Oakland, California) reported completion of a multi-day animal study of a miniaturized, pediatric, ventricular assist device (VAD). The PediaFlow is expected to be the platform for a future minimally invasive adult VAD, intended to meet a large clinical need for earlier-stage heart failure patients. The Levacor is a bearingless, fully magnetically levitated implantable centrifugal rotary pump with clinical experience. The Levacor VAD uses magnetic levitation to fully suspend the spinning rotor, its only moving part, inside a compact housing. In contrast to pumps with blood-immersed mechanical or hydrodynamic bearings, full magnetic levitation is designed to eliminate wear within the pump as well as eliminate dependence on blood properties for rotor suspension.