Three years after winning FDA clearance for its original Merci Retriever — the first medical device cleared by the agency to remove blood clots from the brain in patients experiencing an ischemic stroke —Concentric Medical (Mountain View, California) reported that it has obtained FDA approval its Merci L6 Retriever. The new Retriever joins four others in the Merci Retriever family on the market, providing physicians another choice for restoring blood flow to ischemic stroke patients, the company said.
The Merci L6 Retriever incorporates a 2.7 mm cylindrical helix with attached filaments. The filaments provide an additional mechanism for securing the clot during retrieval, Concentric said. The device is now available for shipment to "qualified accounts," Concentric said.
The Retriever is a shaped-wire made of nitinol — the company billing it as a "memory wire" —which allows linear delivery using standard catheterization techniques. A small puncture in the groin is used to introduce the device into an artery leading to the brain. Upon reaching the targeted area, the Retriever returns to its original shape when deployed, according to the company. The Merci Retriever is designed to restore blood flow by capturing and removing blood clots. The Merci family of systems offers more options for ischemic stroke patients, especially for those who have failed intravenous clot dissolving drug therapy or who could not be treated within the three-hour limit established for intravenous drug administration, the primary drug treatment for stroke.
Andrew Gordon, VP of marketing for Concentric, told Cardiovascular Device Update that the Merci L6 Retriever is different from the company's previous clot removal devices in that it is designed to target larger vessels.
Concentric said its Merci systems are available in more than 225 centers in North America. The company estimates that about 6,000 patients have been treated with its devices. Gordon said the Merci Retriever is still the only FDA-cleared device to remove blood clots from the brain in ischemid stroke patients.
Another company seeking to enter the ischemic stroke market is Ekos (Bothell, Washington), which is developing its Micro-Infusion Catheter MicroLysus infusion system in a clinical trial for the treatment of ischemic stroke. The device, which incorporates ultrasound technology into the tip of a microcatheter to accelerate the dissolving of the blood clot, is cleared for the treatment of peripheral arterial occlusions and deep vein thrombosis.
Earlier this month Concentric also filed a registration statement with the Securities and Exchange Commission for a proposed initial public offering of its common stock to raise up to $69 million, all shares to be sold by the company. The number of shares to be offered and the price range were not available at the time of publication.
The company said that at least $30 million of the IPO proceeds will be used for sales and marketing initiatives to support commercialization of its Merci systems; $10 million for R&D activities, including support of product development; and $7 million for clinical and regulatory initiatives, including $5 million to support the Merci Registry. The remainder will be used for general corporate purposes.
Elsewhere in the product piepline:
- Abiomed (Danvers, Massachusetts) reported receiving conditional approval from the FDA to begin its clinical trial in the U.S. for the Impella 2.5 circulatory support system. The study will determine the safety and effectiveness of the Impella 2.5 as compared to optimal medical management with an intra-aortic balloon pump (IABP) during "high-risk" angioplasty procedures. The study inclusion criteria have been extended to include patients with triple vessel disease with low ejection fraction. The study will compare 327 Impella 2.5 patients to 327 IABP patients and is comprised of two arms made up of patients receiving the Impella 2.5 for up to five days as a left ventricular assist device and patients receiving IABP therapy. Following IRB approval at each participating hospital and requisite training, the company plans to ship Impella 2.5 disposables and Impella consoles to the pivotal sites. The Impella 2.5 is a left percutaneous device inserted while in the cath-lab, which provides patients with up to 2.5 liters of blood flow per minute. It is the world's smallest VAD and has been used to treat conditions such as acute myocardial infarction, cardiogenic shock, and low output syndrome under CE mark approval in Europe. Due to a rise in conditions such as triple vessel disease in patients with poor cardiac function, which is caused by coronary vessel blocks in three vessels of the heart, the Impella 2.5 provides a new treatment option that aims to improve patient outcomes.
- AGA Medical (AGA; Minneapolis, Minnesota) said that it has received FDA and CE mark approvals for the Amplatzer vascular plug II. The Amplatzer is a self-expandable nitinol mesh occlusion device designed to be introduced in a minimally invasive fashion through a catheter. The delivery cable that comes pre-attached uses the Amplatzer user interface to enable the physician to more precisely position the device in the targeted blood vessel. Once positioned, the cable is unscrewed and the device is released. The vascular plug II is designed with multiple lobes to facilitate rapid clotting.The new vascular plug comes in sizes ranging from 3 mm to 22 mm enabling treatment of a wider range of vessel sizes. AGA specializes in the repair of congenital and structural heart defects using non-surgical techniques.
- Atrium Medical (Hudson, New Hampshire) reported the availability of its di-2-ethylhexyl phthalate- (DEHP) free thoracic catheters. The company said DEHP-free catheters are its latest advance in a series of medical device innovations, engineered for improvements in patient outcomes following thoracic drainage intervention. Atrium makes chest drainage products, and chest tube insertion kits.
- Cardica (Redwood City, California) said that two independent groups of cardiothoracic surgeons performed minimally-invasive, closed-chest bypass procedures using its C-Port Flex A Anastomosis system and Intuitive Surgical's (Sunnyvale, California) da Vinci robot. The C-Port Flex A system, a 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 safety, the 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. 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 procedures.
- Cook Medical (Bloomington, Indiana) said it has submitted the final module of its pre-market application to the FDA for the Cook Zenith TX2 thoracic aortic aneurysm endovascular graft. Cook's PMA submission includes safety and efficacy data on about 230 patients who have been treated with the Zenith TX2 in clinical trials. Thoracic aortic aneurysms occur when the section of the aorta that runs down the chest weakens and bulges outward like a balloon. The Cook Zenith TX2, a reinforced fabric tube that is sized to the length of the aorta and covered, is used to seal off the aneurysm. The Zenith TX2 helps to relieve pressure on the aneurysm and reduce the risk of rupture. Cook Medical makes interventional devices.
- Corgenix Medical (Denver) said it has submitted a 510(k) premarket notification to the FDA for its IgG Anti-AtherOx test kit. This new laboratory test uses the company's AtherOx technology to detect IgG antibodies to complexes formed by oxidized low-density lipoprotein (oxLDL) with b2-glycoprotein I (b2GPI) in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). The AtherOx technology uses oxLDL complexed with the plasma protein b2GPI. Although oxLDL has been implicated in cardiovascular disease, clinical data demonstrates that the determination of oxLDL/b2GPI complexes (AtherOx), rather than oxLDL alone, is a more physiologic and accurate way of assessing the risk of progressive atherosclerotic cardiovascular disease. Corgenix licensed the technology in 2002. Corgenix makes specialized diagnostic kits for vascular diseases, immunology disorders, and bone and joint disorders.
- Critical Diagnostics (New York) reported a "pivotal" research paper published in the Journal of the College of Cardiology titled, "Measurement of the Interleukin Family Member ST2 in Patients with Acute Dyspnea: Results from the ProBNP Investigation of Dyspnea in the Emergency Department (PRIDE) Study." It said study results demonstrate the strength of ST2 as a biomarker for risk stratification and prediction of mortality in patients who present to the emergency department with shortness of breath and suspected acute decompensated heart failure. ST2 is a mechanically-induced cardiomyocyte protein, and serum levels of ST2 have been shown to predict outcome in patients with acute myocardial infarction or heart failure. The research described in this paper indicates that ST2 is a powerful biomarker for prediction of near-term mortality in dyspneic as well as acute decompensated heart failure patients. Critical Diagnostics makes the Presage laboratory assays using ST2 for the diagnosis and prognosis of cardiovascular disease.
- CryoCor (San Diego) reported the completion of enrollment of its pivotal clinical study for the treatment of atrial fibrillation. Helen Barold, MD, chief medical officer of CryoCor, said, "We continue to see an excellent safety profile for our cryoablation device and expect to file a PMA in late 2008. At this point we will begin our non-randomized continued access protocol in which patients will be enrolled into the ablation arm." Ed Brennan, PhD, CEO of CryoCor, said, "With the recent approval of our cryoablation system for the treatment of right atrial flutter, in the fourth quarter, we will begin placing our system at high volume ablation centers across the U.S., familiarizing physicians with our system and establishing our installed base of consoles in anticipation of approval for the treatment of atrial fibrillation in 2009." Cryo-Cor has enrolled more than 170 patients in its pivotal clinical study and ssays that it will complete a 12-month follow up for each patient. CryoCor develops treatments for cardiac arrhythmias.
- ELA Medical (Denver), a Sorin Group (Milan, Italy) company, reported the first U.S. implant in NATURE, an observational study that will enroll 1,440 patients in North America and Europe. The objective of the NATURE study is to observe the evolution of atrio-ventricular conduction disorders in pacemaker patients over a two-year period. Patients implanted with either ELA Medical/Sorin Group's Symphony model 2550 or Reply DR dual chamber pacemakers will be included in the study. Data will be collected using AIDA+, ELA's exclusive feature that is capable of identifying different types of atrio-ventricular blocks. Symphony pacemakers are equipped with AAIsafeR, an algorithm designed to deliver right ventricular pacing only when needed. REPLY pacemakers incorporate the same algorithm. ELA manufactures implantable pacemakers and defibrillators.
- A new red blood cell substitute from Hemosol (Toronto) improved the survival of mice with sickle cell disease that were subjected to conditions to simulate a sickle cell crisis, according to a report by Canadian researchers. The product candidate, HRC 101, a hemoglobin-based oxygen carrier, improved survival in mice genetically modified to have a condition similar to sickle cell disease, according to an article in the journal Anesthesiology. Reducing levels of oxygen simulated a sickle cell crisis in the animals. Mark Crawford, MD, and colleagues at the Hospital for Sick Children (Toronto) and the University of Toronto noted in the article that there are risks associated with the use of red blood cell transfusions to treat children during a sickle cell crisis. Sickle cell disease is an inherited condition in which the body produces red blood cells that have a "sickled" shape, rather than a normal oval appearance. Because these sickle cells are not efficient, patients become anemic and the cells periodically obstruct blood flow, especially reducing flow to major organs and other parts of the body, depriving them of oxygen and causing a sickle cell crisis. The researchers administered 0.02 mL/g of the agent or placebo to regular mice and sickle cell mice. The results, they said, show that HRC 101 "protects sickle mice from the lethal effects of acute, severe"oxygen deprivation.
- Lumedx (Oakland, California) has introduced cardiology software that automates donor/recipient record keeping for heart transplant centers, to streamline the process of collecting and managing cardiac transplant patient data from first consultation through evaluation, activation, transplant and post-transplant follow-up visits. The module also allows the heart transplant center to track all donation offers and actual donor information for each patient, enabling the center to meet government record-keeping requirements. Lumedx provides cardiovascular information systems.
- Lumen Biomedical (Plymouth, Minnesota) reported FDA clearance to market two additional sizes of its Xtract aspiration catheter. 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 (4.2 Fr) was granted FDA clearance last year. 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 manfuactures products that can be used in any anatomical area where embolic protection or emboli removal is required.
- MedicalCV (Minneapolis) reported that Steven Bolling, MD, has performed five full Cox-Maze procedures using a combination of the ATRILAZE and SOLAR Surgical Ablation Systems. Bolling, professor of surgery and the Gayle Halperin Kahn Professor of Integrative Medicine at the University of Michigan Cardiovascular Center (Ann Arbor), 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." Marc Flores, president/CEO of MedicalCV, said that the 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. Moving forward, our intent is to aggressively pursue these two market opportunities." ATRILAZE is cleared for ablation or coagulation of soft tissue, including cardiac tissue, and the SOLAR Surgical Ablation System is cleared for the ablation of soft tissue; the systems are not cleared for treatment of cardiac arrhythmias. MedicalCV develops laser-based surgical ablation systems in soft tissue and in cardiac tissue.
- Novare Surgical Systems (Cupertino, California) reported completion of what it says it believes to be the first laparoscopic nephrectomies that left no visible scar. The RealHand HD instruments are full range of motion hand-held laparoscopic instruments. Developed with the EndoLink mechanism, RealHand technology is designed to mirror the surgeon's hand direction with the added benefit of tactile feedback. As such, when the surgeon's hand moves in one direction, the instrument tip exactly follows. RealHand offers 7 degrees of freedom of movement in a hand-held instrument and with no need for additional hardware. RealHand can help surgeons perform more difficult maneuvers that otherwise cannot be completed with traditional rigid instruments. Novare Surgical Systems make devices for cardiac surgery.
- 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.
- Smart Products (Morgan Hill, California) recently introduced its 101 micro barbed check valve. The small valve, which fits 1/8" ID (inner diameter) tubing, is ideal for medical applications that incorporate tubing, including blood pressure cuffs, kidney dialysis, and post-surgery instrumentation — or any application where space is at a premium. The 101 micro barbed check value delivers a range of precise opening pressures that range from 2 PSI to 20 PSI. Due to the spring-loaded design, the 101 barbed check valve does not require pressure to close and can also be used as a pressure relief valve. The valve easily inserts into tubing, which eliminates potential leak points. Check valves are used in applications to restrict the ability of a fluid to flow in one direction (the check direction) while allowing fluid to flow freely in the opposite direction (flow direction). Smart Products makes check valves, pumps, and related components.
- The FDA has approved Evithrom (human thrombin), a blood-clotting protein used to help control bleeding during surgery. Evithrom, manufactured by Omrix Biopharmaceuticals (Ramat Gan, Israel), is the first human thrombin approved since 1954 and is the only product currently licensed. It is derived from human plasma obtained from carefully screened and tested U.S. donors and has undergone steps to further reduce the risk for transfusion-transmitted diseases. Evithrom is indicated as an aid to stop oozing and minor bleeding from capillaries and small veins and when control of bleeding by standard surgical techniques is ineffective or impractical. The product is applied to the surface of bleeding tissue and may be used in conjunction with an absorbable gelatin sponge. Evithrom must not be injected into blood vessels, which would result in serious clinical complications and may even be fatal. "The approval of Evithrom offers an important additional option for surgeons and their patients to help control surgical bleeding," said Jesse Goodman, MD, director of FDA's center for biologics evaluation and research. "Surgeons will now be able to choose between human thrombin and thrombin derived from cattle plasma."
- Thoratec (Chicago) an FDA advisory panel will review, later this year, its premarket application seeking for its HeartMate II, an implantable device used for advanced-stage heart failure patients, as a bridge to transplant. The company said that the FDA has set Nov. 30 as the tentative date for the review by its Circulatory Systems Device Advisory Panel. Recently, the company reported it had filed an amendment to PMA the week of July 23 that it believes addresses all of the significant deficiencies outlined by the FDA in its comment letter. The company also reported that it has now responded to all outstanding questions raised in the FDA's comment letter. Thoratec makes therapies to address advanced stage heart failure.
- 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 2 microglobulin was an independent predictor, even after taking into consideration traditional risk factors such as cholesterol, diabetes, and age. Vermillion is a developer of diagnostic products for cardiology, oncology/hematology and women's health with an initial focus in ovarian cancer.
- Vital Images (Minneapolis, Minnesota) said it has released its next generation enterprise-wide advanced visualization and analysis product solutions with the release of Vitrea 4.0 and ViTALConnect 4.1. This package offers powerful advanced visualization and analysis capabilities via workstation clients, remote clients and Web-based clients. In addition to the new version enhancements, the company also released ViTAL EP, a new electrophysiology (EP) planning application to augment its cardiovascular suite of products and Medicsight's ColonCAD for its InnerviewGI virtual colonoscopy application. Enhancements to the company's Vitrea 4.0 workstation-client release include cardiovascular workflow enhancements such as automatic segmentation and probing of the coronary tree, easier vessel management and labeling, easy centerline editing and comprehensive reporting with automatic population of findings. Neurovascular improvements include motion correction and simultaneous multi-slice computation for true 4-D perfusion for stroke patients. This release also includes improved colon enhancements such as fly-through capabilities, polyp probe and automatic registration of prone and supine, among other significant usability improvements including computer-aided detection (CAD) designed to identify suspicious regions in the colon. Vital Images makes visualization and analysis solutions.
- VivoMetrics (Ventura, California) said that it has made enhancements to its LifeShirt preclinical system by incorporating Bluetooth wireless technology. The upgraded capabilities of the wireless technology deliver fast connections between the LifeShirt and data management systems that measure and quantify the research subject's vital signs. LifeShirt technology has been used in clinical studies of human subjects and has proven to be a reliable and beneficial component of research. The company says that the LifeShirt system is the first non-invasive, real-time ambulatory monitoring system that continuously collects, records and analyzes a broad range of cardiopulmonary parameters. Designed for the needs of the preclinical market, the system includes a lightweight, machine washable garment with embedded sensors that collect pulmonary, cardiac, posture and activity signals from freely moving subjects for up to 24 hours. Data generated is wirelessly transmitted and VivoSoftware allows researchers to monitor and analyze data of up to 16 subjects in real-time or to be stored for later analysis. VivoMetrics makes non-invasive products and services.
- 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. Gore says that 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 reinforced, biocompatible, expanded polytetrafluoroethylene (ePTFE) liner attached to an external nitinol stent structure. The Gore Medical family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair and sutures for use in vascular, cardiac and general surgery.
- World Heart (Oakland, California) reported completion of the first multi-day animal study of a miniaturized, pediatric, ventricular assist device (VAD). The PediaFlow, developed by a National Institutes of Health-funded consortium including WorldHeart, is postioned to be the platform for a future minimally invasive adult VAD, intended to meet a large clinical need for earlier-stage heart failure patients, World Heart said. The animal implant was performed by Peter Wearden, MD, PhD, pediatric cardiac surgeon at the Children's Hospital of Pittsburgh. The six-day study, at the University of Pittsburgh McGowan Institute, focused on hemodynamic performance and biocompatibility under physiologic conditions. The device provided uninterrupted support and met all design targets. Biocompatibility was demonstrated, with no indications of blood damage or clotting. Jal Jassawalla, president/ CEO of World Heart, said, "We are excited that this technology, first embodied in the Levacor VAD, is being extended to the pediatric VAD and then potentially to a WorldHeart minimally invasive adult VAD." The latter, providing partial circulatory support, would serve a broad population with less advanced heart failure and would complement WorldHeart's Levacor VAD. A U.S. feasibility-phase bridge-to-transplant study of the Levacor VAD is planned to begin in late 2007 or early 2008. The PediaFlow is an implantable, magnetically levitated rotary VAD based on WorldHeart's MagLev technology. PediaFlow is being developed to provide medium-term (< 1 year) implantable circulatory support to patients from birth to 2 years of age with congenital or acquired heart disease.
- Zoll Medical (Chelmsford, Massachusetts) has FDA clearance to market and sell the Zoll AED Pro with See-Thru CPR technology. This device helps minimize interruptions in CPR-one of the key recommendations of the American Heart Association guidelines for advanced cardiac life support. See-Thru CPR reduces interruptions by allowing clinicians to see organized electrical activity during CPR compressions by filtering out compression artifact (noise). This lets rescuers see a patient's underlying cardiac rhythm during resuscitation efforts and eliminates the need to stop compressions to see if defibrillation was successful. The AHA notes that a primary source of interruption of CPR is stopping to determine underlying ECG rhythm. Zoll Medical makes resuscitation devices and related software solutions.