CVRx (Minneapolis) last month received the CE mark for its Rheos Baroreflex Hypertension Therapy System, which it said is the only implantable device designed to control hypertension. The company said the system was approved for European marketing based on clinical studies conducted in both Europe and the U.S.

The Rheos System, CVRx says, provides a "physiological rational" method to reduce blood pressure (BP), using the body's own natural BP regulation system, baroreflex, to control blood pressure.

The system includes a small pulse generator implanted under the collarbone; two thin lead wires that are implanted at the left and right carotid arteries and connecting to the pulse generator; and the Rheos Programmer System, an external device used by doctors to non-invasively regulate the activation energy from the generator to the lead wires.

The company says the system "electronically activates the baroreflex," which sends signals to the brain suggesting a blood pressure increase. "The brain then acts to lower blood pressure by sending signals to various parts of the body to reduce blood pressure, including the blood vessels, heart and kidneys."

Abstract results published recently in the Journal of Hypertension reported a significant decrease in BP with the Rheos at 12 months. One-year results from 13 patients showed a 39 mmHg average decrease in systolic BP and a 26 mmHg average decrease in diastolic blood pressure.

Citing receipt of the CE mark as "an important milestone for our company," Nadim Yared, president/CEO of CVRx , said, "Currently, we are focused on advancing the Rheos Pivotal Trial in the U.S. Patient enrollment in the Rheos Pivotal Trial is under way, and we expect outcomes from this study to support our pre-market approval application to the FDA."

The company has received investigational device exemption approval from the FDA to begin the Rheos Pivotal Trial evaluating the safety/effectiveness of the Rheos. The trial is enrolling 300 patients at multiple clinical sites in the U.S. and Europe.

The company noted that hypertension affects about 65 million people in the U.S. alone. It is estimated to cause one in every eight deaths worldwide.

Elsewhere in the product pipeline:

Ascent Healthcare Solutions (Phoenix) reported FDA has clearance of two Ascent 510(k) submissions to reprocess specific Medtronic (Minneapolis) and Guidant (Indianapolis) cardiac stabilization and positioner devices. The Medtronic models include the Octopus evolution tissue stabilizer (as well as the other predecessor Octopus models), Starfish and Urchin Heart Petitioners. Guidant models covered under this clearance include the complete line of vacuum and mechanical systems: Xpose, Ultima and Acrobat systems. The devices are mainly used in Off-Pump Coronary Artery Bypass (OPCAB) or "beating heart" procedures. About 350,000 U.S. patients undergo coronary bypass grafts annually. Currently, about 25% of the general population cases are being performed off-pump. Ascent Healthcare Solutions is an independent third-party reprocessor of single-use medical devices.

• AtriCure (West Chester, Ohio) said that results reporting on the company's minimally invasive products, which physicians have adopted to treat atrial fibrillation (AF), were published in the Journal of Cardiovascular Electrophysiology. The authors reported the results from 20 AF patients. Based on the use of 30-day continuous monitoring at one-year follow-up, 87.5% of the paroxysmal and persistent AF patients and 75% of overall patients were free from AF and left atrial arrhythmias and were also off anti-arrhythmic drugs. There were no reports of major complications. AtriCure makes cardiac surgical ablation products.

• ATS Medical (Minneapolis) reported FDA clearance for the ATS Simulus semi-rigid annuloplasty ring. ATS said that these semi-rigid rings are the next in a series of mitral valve repair products developed through the company's partnership with Genesee BioMedical (Denver, Colorado), a collaboration that works with cardiac surgeons to create a semi-rigid ring with the Flex-Zone anterior segment. "The ring respects the natural motion of the mitral annulus and its proximity to the aortic valve allowing for a safer, more physiologic valve repair," ATS said in a statement. Annuloplasty rings and bands are used in those cases where repair of a patient's heart valve is preferable to valve replalcement. Douglas Murphy, MD, of St. Joseph's Hospital (Atlanta), said: "I have utilized the original ATS Simulus flexible annuloplasty ring and band in hundreds of surgical cases and have been impressed with its superior handling and suturability. A semi-rigid version coupled with the variety of surgical repair techniques available will allow us to further individualize and refine each patient's care…."

• bioMérieux (Marcy L'Etoile, France) said it has received FDA clearance to market Vidas B R A H M S PCT. The test will be used with critically ill patients on their first day of admission to the ICU as an aid to assess their risk for progression to severe sepsis and septic shock. The Vidas platform is well suited to emergency situations, with Vidas B R A H M S PCT providing test results in 20 minutes. The new test completes the large Vidas emergency panel available in the U.S., which includes markers of cardiac necrosis (Vidas Troponin I, CK-MB) and venous thromboembolism (Vidas D-Dimer Exclusion). BioMerieux specializes in in vitro diagnostics.

• Broncus Technologies (Mountain View, California) said that the results of its open-label Exhale drug-eluting stent (DES) feasibility study are published in the October issue of the Journal of Thoracic and Cardiovascular Surgery. Results include a statistically significant reduction in the amount of air trapped in the lungs and an improvement in breathing for patients at six months after the airway bypass procedure. Airway bypass is a catheter-based bronchoscopic procedure designed to reduce lung hyperinflation and improve breathlessness, by making new pathways for trapped air to exit the lungs. During the minimally invasive procedure, new openings are created in the airway wall connecting the damaged lung tissue to the natural airway. These pathways are supported and kept open by Exhale DES devices. The hope is to improve quality of life by relieving severe symptoms including shortness of breath and hyperinflation of the chest. Broncus Technologies makes products for the treatment of emphysema.

• Cardiac Science (Bothell, Washington) reported the launch of the Quinton Q-Tel RMS 3.0, a cardiac rehabilitation system offering connectivity upgrades and workflow advancements to enable the best possible treatment decisions in cardiac rehabilitation. Some features include: bi-directional connectivity to a hospital's EMR and HIS system; improved tracking of HIPAA compliance requirements through user activity logs; session recovery advancements to prevent the loss of patient data due to power interruption or application error and Q-Tel pocket assistant for wireless session management. Cardiac Science makes cardiac monitoring and defibrillation products.

• Cardium Therapeutics (San Diego) and its operating unit, InnerCool Therapies (San Diego), have initiated the launch of InnerCool's new CoolBlue surface temperature modulation system. InnerCool's new CoolBlue surface temperature modulation system, which includes a console and a disposable CoolBlue vest with upper thigh pads, is designed to provide a complementary tool for use in less acute patients or in clinical settings best suited to prolonged temperature management. InnerCool's CoolBlue vest and thigh pads wrap the body without requiring any adhesives to stick to the skin and produce cooling rates of around 1 C per hour, i.e. similar to those of currently-marketed surface cooling systems and endovascular systems using inflatable balloon-based catheters. Cardium and its subsidiaries, InnerCool and the Tissue Repair Company, are focused on products and devices for cardiovascular, ischemic and related indications.

• Cook Medical (Bloomington, Indiana) has received FDA approval to begin a 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. 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.

• CryoCath (Montreal, Canada) reported positive 12-month follow-up data from the second and final cohort of 18 patients treated during the feasibility stage (33 patients total) of its STOP AF (atriall fibrillation) investigational device exemption trial. The results confirm that 14 of the 18 subjects are free of AF, with 12 of the 14 not taking any anti-arrhythmic drug therapy. The trial, now in the pivotal stage, is assessing CryoCath's Arctic Front catheter to treat AF. Arctic Front is a minimally invasive cryo-balloon catheter designed specifically to treat paroxysmal Atrial Fibrillation. This bi-directional, double-balloon catheter enables physicians to rapidly isolate all four pulmonary veins for the treatment of AF. CryoCath makes products to treat cardiac arrhythmias.

• LifeScience PLUS (Santa Clara, California) said that its flagship product, BloodSTOP, has won FDA approval. Touted as being a "high-tech" band-aid, BloodSTOP interacts with blood platelets to form a clear gel that instantaneously blocks the flow of blood, stopping bleeding several times faster than traditional cotton gauze and pressure techniques. Made from natural cellulose, this hypoallergenic gauze is water-soluble, easily washing off without causing additional trauma to the wound area. BloodSTOP can also be cut to fit difficult areas such as the mouth, nose and even deep wounds. Also, because the gauze is transparent, medical professionals can easily monitor the wound. LifeScience PLUS makes medical care products.

• Microlife USA (Dunedin, Florida) reported launch of the Microlife blood pressure (BP) monitoring and Peak Flow/FEV₁ monitoring drivers as a part of its newly launched consumer health platform, Microsoft HealthVault, to provide consumers with a new way to 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 BP 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 BP monitors, digital and infrared thermometers and peak flow meters.

• NMT Medical (Boston) said that the first patients were randomized in its pivotal patent foramen ovale (PFO)/migraine trial in the U.S. — MIST II, designed to evaluate the safety/efficacy of its BioSTAR implant for the treatment and prevention of migraine headaches in patients with a patent foramen ovale (PFO) hole in the heart. The randomization took place at the Swedish Medical Center (Seattle, Washington). The trial currently is being conducted at more than 25 sites across the country. Stewart Tepper, MD, and Mark Reisman, MD, are co-principal investigators of MIST II. "MIST II is a landmark trial that will advance the collective understanding within the medical community of the potential link between PFO and migraine headaches," said Reisman. "The patients enrolled in MIST II will benefit from the only clinical trial which utilizes a device made of bioabsorbable collagen matrix material designed to promote closure of structural heart defects, such as PFO. In addition, MIST II is supported by evidence from a predicate PFO/migraine study, MIST, and several retrospective studies at various medical centers throughout the world." A double-blinded trial, MIST II is designed to randomize about 600 migraine patients with PFO to either PFO closure with Biostar or a control arm. More than 50 migraine headache specialists and interventional cardiologists are participating. NMT makes implant technologies for treatment of structural heart disease via catheter-based procedures.

• Northstar Neuroscience (Seattle) said that the last patient in the company's EVEREST trial for stroke motor recovery completed four week follow-up. EVEREST is a national, multi-center, single-blinded, randomized clinical trial investigating whether Northstar's Renova-ST cortical stimulation system in conjunction with physical rehabilitation improves hand and arm function in stroke survivors compared to those receiving physical rehabilitation alone. The trial is being conducted at 21 stroke centers throughout the U.S. and when complete will include data from more than 150 subjects. Northstar is focused on developing neurostimulation therapies to treat neurological injury, disorder and disease.

• OmniSonics Medical Technologies (Wilmington, Massachusetts), a developer of medical devices for use in the treatment of vascular disease, said that it has received FDA clearance to market 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. The OmniWave is based on OmniWave technology, the first minimally invasive catheter-based technology that delivers low-power, transverse ultrasonic energy to remove thrombus quickly, safely, and effectively. Thrombus (also known as a blood clot) 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. "Clearly, this is a major accomplishment for the company as we continue on track towards building a world-class enterprise that can deliver advanced medical devices to treat vascular disease," said Richard Ganz, president/CEO of OmniSonics. "The OmniWave System is designed to safely and rapidly remove blood clots in a single session. We believe that OmniWave Technology has the potential to be used in a wide range of vascular applications."

• Physio-Control (Seattle) reported that the Lucas chest compression system is available in the U.S. through a distribution partnership with Jolife AB (Lund, Sweden). The Lucas Chest Compression System is an external medical device that provides chest compressions during CPR. Lucas runs on high-pressure air supplied either by a compressed air tank or the air wall outlet in a hospital. Designed for both out-of-hospital and in-hospital use, Lucas is indicated for treatment of adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, as well as loss of consciousness. The system enables hands-free compressions, provides sustained circulation during patient transport in both out-of-hospital and in-hospital situations, makes CPR possible from the field to the hospital and reduces the impact of extenuating circumstances on the interruption and quality of chest compressions, such as transport conditions, and secures the patient's arms before transport and enabling rescuers to sit, wearing seatbelts during transport, rather than standing to provide compressions in a moving vehicle. Physio-Control is a subsidiary of Medtronic (Minneapolis).

• Roche Diagnostics (Indianapolis, Indiana) said that its CoaguChek XS Plus system offers built-in controls and optional, external liquid controls to help non-waived clinics monitoring anticoagulation ensure accurate PT/INR (clotting time) test results for patients taking blood thinner medication. The handheld, battery-powered CoaguChek XS Plus system has the ability to store up to 500 patient and or liquid quality control results that can be searched by patient, date and time. The meter also is designed for data management connectivity with patient ID, operator lockout and quality control lockouts. The system performs two levels of onboard quality controls as part of every PT/INR test, all in a single test chamber, a feature designed to save time and provide enhanced confidence in the quality of results. The CoaguChek PT test strip also neutralizes therapeutic levels of heparin and low-molecular-weight heparin, enabling physicians to do point-of-care testing on a broad range of anticoagulated patients. Roche's diagnostics division supplies a wide array of testing products and services to researchers, physicians, patients, hospitals and laboratories.

• SonoSite (Bothell, Washington) reported the introduction of the M-Turbo ultrasound system for use in the full range of clinical applications at the point of care. The system delivers an increase in processing power for superior image clarity across all exam types, plus connectivity for digital image export in a rugged, hand-carried product weighing less than eight pounds. SonoSite said it plans to begin deliveries later this quarter. SonoSite says that the M-Turbo system offers a 16-fold increase in processing power yet weighs slightly less than the MicroMaxx system. The system's increased processing power generates dramatic improvements in image quality by simultaneously running multiple advanced algorithms: SonoADAPT Tissue Optimization, automatically adjusts imaging parameters depending on exam type and patient size based on imaging depth, thereby eliminating complicated clinician manipulation of multiple controls. SonoHD Imaging Technology — leverages the exponentially increased processing power to reduce speckle noise and other image artifacts while preserving and sharpening tissue information and enhancing the aesthetic and clinical value of the image; SonoMB Multi-beam Imaging, further enhanced and now available on all M-Turbo transducers, including the phased array transducer to facilitate cardiac and abdominal examinations, SonoMB technology was first introduced in April 2007 as a software upgrade for the MicroMaxx system.

• Terumo Interventional Systems (Somerset, New Jersey) reported launch of the TR Band, a radial artery compression device designed to comfortably stop bleeding after transradial procedures. The TR Band has a transparent band and precision pressure balloons that enable unobstructed visualization and monitoring of radial artery compression, all while preventing numbness and pain for enhanced patient comfort. The primary benefit that the TR Band has over similar devices is its directed radial compression, which enables hemostasis achievement without compromising local nerve structure. The TR Band does so with two separate, inflatable balloons. A large balloon compresses the entire puncture site and a small balloon gives it an angled direction for point compression. Terumo makes guidewires, catheters, introducer sheaths, guiding sheaths and embolization products for use in a multitude of different interventional procedures.

• Textronics (Wilmington, Delaware) reported that it has developed a transmitter for use with the stretchy fabric electrode sensors that are knit into the company's NuMetrex brand of heart rate monitor fitness apparel. The new transmitter snaps into a tiny pocket in NuMetrex sports bras and shirts, where it receives the heart rate signal from textile sensors located across the chest band area. The data is then transmitted to a watch or exercise machine that displays a read-out of the heart rate. The company says that the NuMetrex system is compatible with most analog heart rate monitor watches including Polar, Nike, Reebok, Oregon Scientific, New Balance, Highgear and Accumen models, as well as gym-quality treadmills and elliptical machines. "By replacing the conventional hard plastic electrodes with soft, flexible textile sensors that are knit directly into the fabric of our clothing, we are able to offer the most comfortable heart rate monitors on the market," said Stacey Burr, CEO. "Now, with the development of our own transmitter, we can also provide improved accuracy and compatibility with many different brands of watches. This makes our comfortable solution accessible to more people." The transmitter sorts through feedback to bring accurate data to the wearer. It is ergonomically designed to fit comfortably against the sternum without rubbing. Textronics develops textile sensor systems used to capture physiologic data from the body. It sells sensor components and markets its own line of clothes for personal monitoring under the brand name NuMetrex.