If ongoing trials are successful, the device sector may one day have another innovative implantable technology, this one used to treat difficult-to-manage high blood pressure, particularly in patients who have a resistance to hypertension drugs. CVRx (Minneapolis) reported that it has received FDA approval for a conditional investigational device exemption (IDE) to begin a pivotal clinical to evaluate the safety and effectiveness of its Rheos baroreflex hypertension therapy system, an implantable device to treat high blood pressure.
The blinded study, sponsored by the company, is a prospective, randomized, multi-center trial that will be conducted at up to 40 sites in the U.S. The study seeks to determine the safety and effectiveness of the Rheos System when used in drug-resistant hypertension patients. To be enrolled in the trial, patients need to be resistant to treatment with at least three anti-hypertension agents, including a diuretic. Their systolic blood pressure must be greater than or equal to 160 mmHg. Data from this clinical trial is intended to support the pre-market approval application for the Rheos system to the FDA.
The Rheos system, CVRX's flagship product, is intended for use in patients who cannot control their blood pressure with medications, or medication combined with lifestyle modifications. The device provides what physicians might describe as a "physiologically rational" method to reduce blood pressure. It is designed to do this with the use of mild electrical signals to influence the body's blood pressure regulation system, called the baroreflex.
According to Robert Kieval, founder and current vice president and chief technology officer of CVRx, the Rheos is a pacemaker-like device designed to stimulate tissues within the body. "We stimulate areas of the vascular system that have sensors in them that report blood pressure to the brain," he told Cardiovascular Device Update. "The brain compares what it believes is the blood pressure to the needs of the body and then makes the appropriate adjustments."
Kieval said that the signals that the device generates are interpreted by the body as a rise in blood pressure that needs to be corrected. The brain then works through the body's own blood pressure control mechanisms to attempt to restore blood pressure to normal. Thus, in essence, it fools the body and leads to a net reduction in blood pressure. Kieval likened this mechanism of action to the ability to cool a room by holding a match under a thermostat: "The heat of a match fools the thermostat into thinking that the entire room has become too warm and causes the air conditioning system to be activated."
The device has thus far enjoyed early clinical success in European and U.S. feasibility clinical trials for its evaluation. European patients started enrolling in the trial in 2004. Early results for the first 12 patients were reported at the European Society of Hypertension meeting in June 2006.
Elsewhere in the product pipeline:
• Boston Scientific (Natick, Massachusetts) reported the launch of software enabling its Left Ventricular (LV) Offset feature in the company's Contak Renewal, Renewal 3, and Renewal 3 RF cardiac resynchronization therapy defibrillators (CRT-D). LV Offset allows physicians to further fine tune synchronization of the heart by allowing adjustment of the delay between right and left ventricular pacing, which helps physicians provide more tailored care for heart failure patients. The software will operate on the Zoom Latitude programmer and allow patients who have already been implanted with a Contak, Renewal 3 or Renewal 3 RF CRT-D to have the LV Offset feature activated. The LV Offset feature can be enabled by the Zoom Latitude programmer during a patient's routine in-clinic visit. Boston Scientific CRM said it will begin providing the FDA-approved software to physicians "in the coming weeks."
• Cardica (Redwood City, California) received FDA 510(k) clearance to market its C-Port xA Distal Anastomosis System. The system automates the creation of anastomoses, or attachments of blood vessels and grafts, such as those in coronary artery bypass graft (CABG) surgeries. The system is designed to deploy staples around the periphery of the anastomosis to help provide leak-proof sealing. Other features include improved access to the coronary artery and reduction of target site preparation; optimization of the staple configuration; and incorporation of vessel clamps for ease of loading the graft vessel for anastomosis. The C-Port xA system received the CE mark in July 2006 and is currently marketed in Europe. Cardica designs and manufactures automated anastomosis systems for CABG surgery.
• CardioDynamics (San Diego), a developer of BioZ impedance cardiography (ICG) technology, reported the publication of a cost-effectiveness study in the Fall 2006 edition of American Heart Hospital Journal. The study showed that use of ICG was cost-effective in both the short and long term compared to standard care treatment of uncontrolled hypertension. In the previously-published CONTROL trial, use of ICG in the treatment of uncontrolled hypertension resulted in an 8 mm Mercury (mm Hg) greater systolic blood pressure (BP) reduction and a 7 mm Hg greater diastolic BP reduction than standard care. Until the completion of this study, it was unknown whether the clinical benefits of using ICG in uncontrolled hypertension could also be considered cost-effective, CardioDynamics said. The short-term cost-effectiveness analysis demonstrated that the additional BP reduction with ICG care in the CONTROL trial was achieved at a significantly lower incremental cost than the cost of reducing blood pressure with standard care. ICG care incremental cost per mm Hg reduced was $20 for systolic blood pressure (44% less than standard care's $36 cost per mm Hg reduced) and $23 for diastolic blood pressure (71% less than standard care's $79 cost per mm Hg reduced).
• CardioVascular Technologies (Palo Alto, California) has received a Notice of Allowance for its patent application, titled "Vascular Couplers, Techniques, Methods, and Accessories." The coupler system enables clampless coronary artery bypass graft (CABG) surgery, minimizing aortic manipulation and embolic dislodgement by not requiring cross-clamping or aortic side-biting during the procedure. By not utilizing a clamp on the aorta, the system is designed to reduce the incidence of postoperative cognitive dysfunction, which occurs in up to about 50% of patients undergoing CABG procedures. The sutureless vascular coupler system can be used during cardiopulmonary supported procedures, as well as off-pump/beating heart, minimally invasive direct coronary artery bypass (MIDCAB), endoscopic or robotically assisted surgical procedures. CardioVascular Technologies specializes in developing surgical and catheter-based technologies.
• CoreValve (Irvine, California) said that its ReValving System, consisting of an 18 Fr size delivery catheter, was used to percutaneously implant its porcine pericardial-tissue bioprosthesis over the severely calcified aortic heart valve of an 89-year-old female patient. In contrast to long post-surgical recuperation times, this "pure" PAVR patient was discharged from the ICU to the general ward on the morning after her ReValving procedure and was fully mobile and awaiting discharge from the hospital, the company said.
• CryoCath (Montreal) has received notification from the FDA allowing the company to expand its pivotal investigational device (IDE) STOP AF trial. The company can now enroll up to 150 patients in up to 20 centers. To date, five centers have received Internal Review Board (IRB) approval and have begun screening patients, including 16 that have already been enrolled and randomized. As many as 250 patients, randomized into two arms, will be enrolled to complete the trial. One cohort will receive cryoablation therapy with Arctic Front (the ablation arm); the other will receive currently prescribed drug therapies (the control arm). For every two patients in the ablation arm, there will be one in the control arm. Patients in the trial will be highly symptomatic paroxysmal atrial fibrillation (AF) patients who have failed at least one anti-arrhythmic drug. The trial's primary endpoint will be the absence of detectable AF at the end of the 12-month follow-up period. The trial's design also allows patients randomized into the drug arm to cross over into the ablation arm if they do not show improvement. Arctic Front is a minimally invasive cryo-balloon catheter designed specifically to treat AF. This bi-directional, double balloon catheter enables physicians to rapidly isolate all four pulmonary veins for the treatment of AF. Approved in Europe, it has treated more than 300 patients in more than 18 centers. CryoCath makes cryotherapy products to treat cardiovascular disease.
• CryoCor (San Diego) has filed a pre-market approval (PMA) application for the treatment of atrial flutter (AFL). CryoCor said it has developed a disposable catheter system based on its proprietary cryoablation technology for the minimally invasive treatment of cardiac arrhythmias. The Cryoablation System is designed to treat cardiac arrhythmias through the use of cryoenergy, or extreme cold, to destroy targeted cardiac tissue. In the U.S., CryoCor is conducting a pivotal trial to evaluate the safety and efficacy of the Cryoablation System for the treatment of AF, and has submitted a PMA for the treatment of AFL. CryoCor is a medical device company focused on the treatment of cardiac arrhythmias.
• diaDexus (South San Francisco, California) re-ported the publication of a study showing that lipoprotein-associated phospholipase A2 (Lp-PLA2), a cardiovascular-specific inflammatory enzyme associated with unstable plaque, is a strong predictor of recurrent stroke. The report, based on the Northern Manhattan Stroke Study, appears in the Oct. 23 issue of Archives of Internal Medicine. The study followed 467 patients, diagnosed as having a first stroke, for about four years. Results showed that those with the highest levels of Lp-PLA2 had an increased risk of recurrent stroke, heart attack or vascular death, even after adjusting for factors such as age, sex, ethnicity and history of heart disease. Lp-PLA2 was measured using the diaDexus' PLAC test.
• Diagnosoft (Lutherville, Maryland) said it received FDA clearance for its Diagnosoft HARP software designed to assist in the analysis of MRI by providing quantitative measurements and visualization of regional heart function. Beta versions of the software have already been licensed for research purposes to more than two dozen research-oriented institutions around the world, the company said. With FDA approval, the software is now cleared for clinical applications and can be used by radiologists, cardiologists, and pharmaceutical companies in assisting the diagnosis, staging, and monitoring heart disease as well as in the development of new therapies. Diagnosoft is a medical imaging company specializing in computer-aided diagnostic software.
• FlowCardia (Sunnyvale, California) reported that Naveen Sachdev, MD, from Providence St. Vincent's Hospital (Portland, Oregon) enrolled the first patient into the Peripheral Approach to Recanalization in Occluded Totals (PATRIOT) study. FlowCardia's 10-hospital, 85-patient PATRIOT U.S. pivotal study is designed to determine the safety and efficacy of the Crosser 14 and Crosser 18 Catheters for CTO recanalization in the upper and lower legs. The Crosser system is a monorail catheter delivered over standard .014" and .018" guidewires to the site of a CTO. The CROSSER uses high-frequency vibration to cross CTOs allowing for subsequent plaque debulking, balloon angioplasty and stent placement. For many patients with chronic occlusions in the legs, this minimally invasive, endovascular approach to CTO recanalization will eliminate the need for potentially traumatic bypass surgery or amputation, the company said. FlowCardia also announced FDA 501(k) submission for the CROSSER 14 coronary platform. The data used to support the coronary submission came from FlowCardia's 19-hospital, 125-patient U.S. FlowCardia's Approach to Chronic Total Occlusion Recanalization (FACTOR) pivotal study. FACTOR was designed to assess the safety and efficacy of the Crosser catheter for chronically occluded coronary artery recanalization.
• Hydromer (Branchburg, New Jersey) has developed an anti-thrombogenic polymer coating complex (F202) designed to minimize blood coagulation. The surface bonding capabilities of the F202 polymer, which maintains long-term non-leaching properties, "are outstanding on a wide variety of medical materials such as cardiovascular devices and stents, hemodialysis equipment and intravenous catheters," the company said. Hydromer said it will target device manufacturers who will enter into confidentiality agreements with non-analysis restrictions, submit their device samples for trial coating and provide feedback to Hydromer.
• Instrumentation Laboratory (IL; Lexington, Massachusetts) reported receiving FDA 510(k) clearance for its HemosIL Homocysteine assay, an automated, latex-enhanced immunoassay for the quantitative determination of total L-homocysteine (Hcy) in human citrated plasma on IL Coagulation Systems. Elevated levels of Hcy are associated with a variety of pathologies, particularly those which increase risk of cardiovascular disease and venous thromboembolism. HemosIL Homocysteine is the first fully automated Hcy assay dedicated to the Hemostasis laboratory, the company said. It allows for an extended thrombophilia work-up on a single coagulation instrument, in combination with other specialty assays. Hcy is derived from the metabolism of methionine, an essential amino acid in the diet. The normal adult range of total Hcy is 5 - 15 umol/L. An increase of 5 umol/L total Hcy corresponds to a 27% higher risk of venous thromboembolism (VTE). Instrumentation Laboratory makes in vitro diagnostic instruments, related reagents and controls for use primarily in hospitals and independent clinical laboratories.
• MedicalCV (Minneapolis) reported that it has been notified by the U.S. Patent Office that it will allow four of the company's patent applications covering various methods and apparatus for treating tissue, including treatments for atrial fibrillation. The coverage provides protection for use of both the company's minimally invasive system and the surgical wand products. MedicalCV develops products used by cardiac surgeons to ablate cardiac tissue to treat atrial fibrillation. Its core technology is the AtriLaze Ablation System.
• Orgis Medical (Lake Forest, California) reported that the U.S. Patent and Trademark Office has granted the company its 13th patent, "Implantable Heart Assist System and Method of Applying the Same." The patent covers the miniaturization of the company's Cancion and Exeleras systems for direct placement of a pump, blood flow conduits and pump control electronics directly into the vasculature of congestive heart failure patients. The Cancion system is being studied in the MOMENTUM pivotal trial and the first clinical use of the Exeleras system is expected next year.
• PLC Systems (Franklin, Massachusetts) said the FDA has granted conditional approval of an investigational device exemption to conduct a pilot clinical trial to evaluate the safety of the RenalGuard system and to measure and balance fluid inputs and outputs in patients undergoing a catheterization procedure where contrast media will be administered. RenalGuard is designed to provide balanced replacement hydration therapy to high-risk patients undergoing imaging procedures where contrast agents are administered. PLC develops technologies for the cardiac and vascular markets.
• Possis Medical (Minneapolis) reported receiving FDA clearance for its AngioJet Xpeedior catheter to remove thrombus from peripheral veins. The Xpeedior, used with Possis' AngioJet System, is the only device cleared for removing thrombus — a treatment known as thrombectomy — in peripheral veins, according to Possis. The Xpeedior catheter is cleared for removing thrombus from upper- and lower-extremity peripheral veins 3 mm and larger in diameter and it is cleared for vascular use with Possis' Power Pulse Delivery, a procedure that sprays smaller doses of clot-dissolving medicine directly into the thrombus and then quickly removes the softened clot material. Possis said the AngioJet System used for venous thrombectomy is identified as a reimbursable procedure for both physicians and hospitals. The company estimates that the realizable market opportunity for venous thrombectomy now exceeds $85 million, and will grow to more than $100 million by 2010.
• Radiant Medical (Redwood City, California) reported initiation of its COOL RCN trial, a safety and efficacy study of catheter-based cooling in patients undergoing cardiac catheterization at risk of developing radiocontrast nephropathy. The Reprieve Endovascular Temperature Therapy System is designed to enable the rapid induction of hypothermia in a conscious or unconscious patient by use of a venous heat exchange catheter. A catheter is threaded into the femoral vein and positioned in the inferior vena cava. As cool sterile saline is circulated within the catheter, blood flowing past the catheter is cooled, and the blood then reduces the body temperature. To rewarm the patient, the sterile saline within the catheter is simply warmed. Radiant's endovascular temperature therapy systems are to treat patients with acute ischemic or inflammatory medical conditions, such as heart attack, radiocontrast nephropathy, stroke and cardiac arrest.
• Siemens Medical Solutions (Malvern, Pennsylvania) is introducing the Axiom Artis dBA Twin, an imaging system designed for universal angiography and the highly specialized field of neuroradiology, at this week's scientific assembly and annual meeting of the Radiological Society of North America. The Axiom Artis dBA Twin is a milestone in advanced biplane imaging. The system features the largest biplane anatomical coverage available, and is uniquely equipped with two 30 x 40-cm flat detectors. The Axiom Artis dBA Twin provides flexibility across a complete applications spectrum, from neuroradiology to cardiac imaging, with fine detail resolution in 2-D and 3-D. Flat detector biplane technology delivers exceptional detail resolution to support both diagnostic and interventional decision making, the company said. The system supports the latest cross-sectioning 3-D imaging techniques with the optional syngo DynaCT cross-sectional imaging capability.
• Spectranetics (Colorado Springs, Colorado) reported that it has received FDA clearance to market its Turbo elite product line for the treatment of blockages within leg arteries. The Turbo product line is designed for improved pushability, trackability, and ablation capability as a result of an improved outer jacket and inner guidewire lumen, and additional laser fibers in most sizes, the company said. Spectranetics makes single-use medical devices used in minimally invasive surgical procedures within the cardiovascular system in conjunction with its excimer laser system.
• Stereotaxis (St. Louis) reported FDA 510(k) clearance of its Niobe magnetic navigation system for use in neurovascular and peripheral applications with the company's family of Cronus magnetically enabled .014" vascular guidewires. Stereotaxis had previously received FDA clearance to use the Niobe System and Cronus guidewire family in coronary vasculature procedures only. The Cronus guidewire family will now integrate with the Niobe magnetic navigation system to provide precise magnetic guidewire navigation in coronary, neurovascular and peripheral anatomy. "[T]this clearance provides us with the flexibility to do so at a time of our choosing," said Bevil Hogg, president/CEO of Stereotaxis. Stereotaxis' instrument control systems are used in the interventional surgical suite.
• St. Jude Medical (St. Paul, Minnesota) reported FDA approval of its new tachycardia software for the Merlin Patient Care System, a computer used to program and interrogate cardiac rhythm management devices like pacemakers and implantable cardioverter defibrillators (ICDs). The software upgrade, which will be launched over the coming weeks, extends the benefits of the previously released Merlin graphical user interface to both St. Jude Medical pacemaker and ICD products. The Merlin Patient Care System, which received FDA approval in April 2006, is a programmer designed to help physicians conduct tests and analyze therapeutic and diagnostic data more efficientyly.
• Tryton Medical (Newton, Massachusetts) reported completion of the company's first 10 clinical cases using its Side-Branch Stent and that all patients in the trial had coronary blockages involving a side branch and were successfully treated using the stent without any in-hospital complications. Richard Davis, co-founder and chief technical officer of Tryton said these bifurcated lesions account for 20% of all coronary lesions treated. He said the new Side-Branch Stent functions like a standard workhorse stent, but its specific task is to treat bifurcated lesions. The typical way to treat bifurcated lesions is to "provisionally" span the Y with a straight stent, in the hope of saving one vessel and, if there is enough blood flow afterwards, attempting to save the second vessel. The company says that the Side-Branch Stent is designed to save the side branch, and at the same time providing blood flow and access to the main vessel.
• Vascular Solutions (Minneapolis) has received FDA 501(k) clearance for its D-Stat Dry hemostatic bandage. The company said the product reduces time to hemostasis in patients undergoing diagnostic femoral catheterization procedures. The D-Stat Dry hemostatic bandage is a thrombin-based pad together with an adhesive bandage that can be applied for rapid control of topical bleeding. Vascular Solutions develops solutions for interventional radiology and cardiology.
• Viasys Healthcare (Conshohocken, Pennsylvania) reported receiving FDA 510(k) clearance for its Sonara and Sonara/tek digital Transcranial Doppler (TCD) systems and introduced that it the systems at the Medica meeting in Düsseldorf, Germany. TCD is a noninvasive method of measuring blood flow velocities in the arteries of the brain using ultrasound Doppler technology. Sonara and Sonara/tek systems were developed with a new digital data acquisition approach which is designed to provide higher resolution data.