ZOLL Medical Corporation (NasdaqGS: ZOLL), a manufacturer of medical devices and related software solutions, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration to market and begin distribution of the new Propaq® M Monitor, a vital signs monitor for deployable military medicine that was developed to meet the special needs of military customers and air medical operations worldwide. Development of this product was a joint undertaking between the Department of Defense and a cooperative arrangement between Welch Allyn and ZOLL. Development was facilitated with grants from the U.S. Army Medical Research and Development Command.

The Propaq M is a new ultra-lightweight, compact device that combines highly sophisticated, advanced capabilities with the well-accepted and proven features of the Propaq monitors. New features of the Propaq M include 12-lead monitoring, a third invasive pressure channel, extensive trending and data collection, a large high-contrast color display with 4-waveform capability, a night vision goggle (NVG) mode for military and air medical night operations, and a user-removeable battery that will operate all the physiological parameters for over 7.5 hours. These new capabilities were designed into a new small, lightweight, rugged package nearly 5 lbs. lighter than currently deployed technology.

The Propaq M is a companion monitor version of the recently FDA-cleared Propaq MD transport monitor/defibrillator and has been developed to have a completely identical and common interface for operation, batteries, power supplies, blood pressure cuffs, cables, accessories, and data. This common interface between the Propaq M and Propaq MD facilitates a seamless transition and operator readiness. The Propaq M is the first transport monitor to utilize the same user interface and components as the Propaq MD, thus allowing military and air medical services to save significant expenses in training and logistics. These new products comprise the first system designed with a combination of interchangeability, flexibility, and portability to meet the special needs of critical care monitoring and therapy for the military.

“These two products, when combined, will meet the most expansive needs of the military for patient care in difficult environments,” said Jonathan A. Rennert, President of ZOLL. “The FDA clearance of both devices is a significant milestone for ZOLL. Given the success of earlier Welch Allyn Propaq monitors and ZOLL M Series® CCT (Critical Care Transport) monitor/defibrillators, we are well-positioned to capture a significant share of the military market as the need to replace and upgrade devices creates substantial business opportunities.”

In addition to the common interfaces between the Propaq M and Propaq MD, virtually all existing Propaq 206 monitor accessories, cables connectors, and ZOLL M Series CCT defibrillation accessories currently used in military applications will be compatible with the new products.

Designed specifically for the tough demands of battlefield medicine, encompassing air transport and evacuation, and highly mobile ground, sea and air deployments of medical assets, the Propaq M meets an unprecedented number of military and international standards related to durability, environmental operation and storage extremes, radio frequency emissions, and susceptibility to spurious electrical and radio frequency noise. The Propaq M, like Propaq MD, is rated to the most stringent water and sand/dust protection, achieving a rating of IP55, allowing protection from extremely fine sand and jets of water.

Source:
ZOLL Medical Corporation

Medtronic Inc.’s (NYSE:MDT) Integrity coronary stent received pre-market approval from the Food & Drug Administration and logged its first U.S. implantation.

The Fridley, Minn.-based medical device giant based the bare-metal stent on its so-called “continuous sinusoid technology,” which uses fewer welds than earlier stent models, such as the Driver, and a single wire of cobalt alloy.

The company designed the device to be more deliverable, or easier to insert. The stent’s first implantation, however, allowed it to exhibit its properties of comformability, according to Washington Adventist Hospital director of cardiac and vascular research Dr. Mark Turco, a Medtronic consultant, who performed the stent’s first implantation today.

Turco told MassDevice that the procedure involved a “bifurcation in the distal right corner artery” and while it didn’t significantly demonstrate the device’s deliverability, the operation “tested comformability in that it was an angulated right corner artery and that [the device] also allowed for good access into the side branch that was involved.”

Conformability is a measure of the stent’s ability to conform to the natural shape of the vessel, according to Medtronic.

The Integrity stent is “going to hopefully allow Medtronic to have another drug-elution vehicle for their drug-eluting stent program,” Turco said.

“It will be interesting to see whether this particular design helps with things like side-branch access and in treating bifurcation lesions,” he added.

Medtronic won CE mark approval for the Integrity stent system in February and the device is available in approximately 100 countries outside the U.S. The company said the stent enabled the it to lead the bare-metal stent market in Western Europe and Central Asia.

A company spokeswoman said continuous sinusoid technology will serve as the foundation for Medtronic’s pipeline going forward. Medtronic announced the FDA approval and implantation today ahead of the 2010 Transcatheter Cardiovascular Therapeutics conference in Washington, D.C.

ReNu Medical, Inc., an environmentally safe and sustainable medical device reprocessor, announces that in August 2010, FDA completed a full Quality Systems inspection without noting any observations or deficiencies. This is the fifth consecutive inspection that ReNu Medical has demonstrated full compliance with the federal regulations for quality in medical device manufacturing and reprocessing.

“This impressive record of continuing full compliance with the federal Quality Systems Regulation demonstrates the commitment this company has to providing its customers with safe, effective reprocessed medical devices,” said Don Selvey, international-recognized expert in medical device reprocessing and ReNu Medical Board Director. “ReNu Medical continues to work diligently to reprocess non-sterile medical devices according to best practices, and to exceed customer expectations for quality medical devices.”

Since the inception of the company in 2000, ReNu Medical has been inspected by the FDA on a regular basis, in accordance with the federal laws for medical device manufacturers. Consistently, the FDA inspectors find the company to be in full compliance with all requirements.

When a deficiency is found in an inspection, FDA provides formal notice of violation and requires the company to provide a written plan to correct problems. If a company fails to correct the violation, FDA may seek sanctions against the company, up to an including civil and criminal charges. Companies with serious violations can be found through public records on the FDA website, located here.

“Consistently receiving Establishment Inspection Report’s (EIR) with zero deficiencies from the FDA, is the best assurance we can give our hospital customers and their patients, that ReNu Medical provides the safest, highest quality reprocessed products possible in the industry,” said Randy Long, ReNu Medical CEO.

ReNu recommends to hospitals that as part of any current contract review, or prior to executing a new contract with a medical device manufacturer or reprocessing company, they review the history of Warning Letters and Establishment Inspection Reports (EIR) from each company. These reports provide a clear indication to hospital purchasing agents and quality assurance authorities how that company values quality in their products.

“We follow the strictest safety protocols,” said Bruce Pierson, ReNu Medical COO. “It’s very gratifying to have the FDA recognize our proprietary methodology and protocols meet their high standards for reprocessed medical devices. Our trained professionals ensure that full regulatory compliance is employed in every step of the process delivering a 100% non-toxic, safe, quality alternative to healthcare facilities nationwide.”

ReNu continues its long standing focus on patient safety and cost savings while maintaining the highest levels of compliance with FDA guidelines and standards.

Source:
ReNu Medical

LensAR, Inc., the leading developer of next generation laser technology for cataract surgery and presbyopia, announced that the company has received 510(k) clearance from the FDA for use of the LensAR Laser System for anterior capsulotomy during cataract surgery.

The LensAR Laser System integrates propriety ocular measurement and 3D laser scanning technologies with an advanced tissue cutting laser. The clinical data from the APEC Hospital Mexico City showed the laser capsulotomies were significantly more precise than manual capsulorhexis in the intended vs. achieved diameter and in circularity.

“The capsulotomy is arguably the most critical and precise step in cataract surgery and the ability to improve its sizing, centration, and consistency through automation is an important and exciting advance,” stated Dr. David F. Chang, LensAR Medical Monitor, who has personally used the LensAR Laser System in Mexico.

Dr. Louis D. “Skip” Nichamin, Medical Advisory Board member, who also has had experience using the system directly, commented, “The application of femtosecond technology to cataract surgery is the most exciting development in ophthalmic surgery in decades. The increased precision of the LensAR technology can help in the improvement of surgical outcomes while assisting experienced and inexperienced surgeons achieve more consistent results.”

“This is a critical milestone for the company. Our first cleared indication of what we believe will be many to come in this exciting new field of laser cataract surgery,” said Randy Frey, founder and chief executive officer of LensAR.

About LensAR, Inc.

LensAR, Inc. is the leading developer of next generation laser technology for cataract surgery and presbyopia. The LensAR Laser System, which integrates an advanced ultra short pulse laser with propriety ocular measurement and laser scanning technologies, is being designed to allow physicians to perform several of the steps in cataract surgery (capsulotomy, lens fragmentation, precise astigmatic corrections and unique clear corneal incisions) in a single laser procedure. In addition to advancing its laser technology in the area of cataract surgery, the company is also developing the LensAR Laser System for the treatment of presbyopia.

The LensAR Laser System is cleared by the FDA for anterior capsulotomy. For other indications it is an investigational device limited by United States law to investigational use only.

Source: LensAR, Inc

Optovue, a pioneer in fourier/spectral-domain optical coherence tomography (OCT), has announced that the new iVue compact SD-OCT has received FDA 510(k) clearance on April 29, 2010.

“The iVue compact SD-OCT was officially launched outside the United States in January of this year, and we have seen very high demand – as expected – in the first quarter,” stated Paul Kealey, Vice President of Marketing for Optovue. “This regulatory clearance for the US market allows us to offer the benefits of advanced OCT imaging to more segments within eye care, where the economic feasibility of the larger systems simply did not work. The iVue begins the next phase of the OCT revolution in the US that started with the RTVue launch in 2006.”

The iVue compact SD-OCT system is delivered on a standard slit lamp style base and is comprised of a small scanning head (4.5 lbs / 2.2 kg), a control module, laptop PC and foot switch. The system can be mounted to a small table and may have other mounting options in the near future for other eye care environments.

About RTVue and iVue

RTVue was the first FDA cleared Fourier domain (also known as spectral domain) OCT launched in the United States, and also the first OCT cleared by the U.S. Food and Drug Administration for both corneal and retinal imaging. The iVue is the compact fourier-domain version of the RTVue OCT, offering the same scanning speed and resolution as the larger system, that includes scanning and reports for retina, retina nerve fiber and cornea assessment by the clinician.

About Optovue

Optovue Incorporated is a privately-held ophthalmic device company dedicated to working with eye care professionals and clinical researchers to lead the commercialization of new imaging modalities that improve diagnosis and therapy of ocular disease. Optovue has achieved widespread market success through a combination of unique data analysis design, a reputation for excellent customer service, and rapid innovation of its technology in response to physician feedback. The company is headquartered in Fremont, CA, with operations in Carlsbad, CA and European operations in Heidelberg, Germany.

Source: Optovue

Embrella Cardiovascular™, Inc., a medical device company, announced its European notified body has granted CE Mark approval for the company’s Embrella Embolic Deflector®, an aortic embolic protection device which acts as a protective shield to reduce the incidence of embolization to the brain. This approval will allow the Company to begin marketing the device in European countries and other countries around the world that recognize the CE Mark approval process.

The Embrella Embolic Deflector® will serve as an adjunctive device to be used in procedures such as the less invasive Transcatheter Aortic Valve Implantation (TAVI) procedure. This technology is currently approved in Europe for high risk patients with severe aortic stenosis. Frequently the aorta contains atheromatous plaque and the valve can be densely calcified. During TAVI, wires, catheters and balloons pass over the aortic arch where they may dislodge debris and calcific particles. Unless deflected from the arteries leading to the head, such debris may embolize to the brain and cause stroke.

Commenting on this CE Mark approval, Embrella Chairman and CEO, Jeffrey O’Donnell said, “The TAVI market is expected to grow dramatically over the next few years. According to analysts, the global TAVI market is expected to grow from over $200 million in TAVI sales in 2009 to over $1.7 billion in 2015. This approval enables us to begin to commercialize the Embrella Embolic Deflector® in European markets. We believe that cerebral protection will be used as a standard of care in all Transcatheter Aortic Valve Implantation procedures.”

“We are pleased that we continue to receive positive feedback from physicians in Europe and Canada. They not only find the Embrella Embolic Deflector® to be intuitive and easy to use, but it also performs effectively without affecting the index procedure,” added Carol Burns, Vice President, Product and Business Development.

Source
Embrella Cardiovascular

BIOTRONIK announced that the U.S. Food and Drug Administration has cleared the Evia® pacemaker for distribution in the U.S., giving physicians and patients access to a unique Bradycardia system designed and manufactured with BIOTRONIK’s unparalleled legacy of quality.

Evia® is the only device that provides a decade of longevity and innovative therapies for physiologic pacing packaged into a device that is 20 percent smaller than our current can size and which has integrated wireless remote monitoring. BIOTRONIK is a leading manufacturer of high-quality implantable cardiac devices and the pioneer of wireless remote monitoring technologies.

Setting the Standard for Remote Monitoring

Evia provides advanced patient management with the complete integration of the clinically proven1 BIOTRONIK Home Monitoring® system. BIOTRONIK introduced home monitoring to the industry almost a decade ago with a system that today monitors, stores data, and provides physicians with early alerts that save lives and prevent hospitalizations. Evia has the unique capability to cellularly transmit required patient and device data, including IEGM Online HD, to perform a complete remote follow-up. It is the world’s smallest pacemaker with integrated wireless remote monitoring. This technology is fully compliant with Heart Rhythm Society and European Heart Rhythm Association device follow-up specifications. Last year, the FDA approved BIOTRONIK Home Monitoring® as the only remote monitoring system on the market that can replace conventional device interrogation during follow-ups.

Quality in every step of the production process

“BIOTRONIK looks forward to providing physicians with the important advancements Evia will bring to their practices. Evia is the latest example of BIOTRONIK’s absolute commitment to deliver quality products designed to enhance patients’ lives,” commented Jake Langer, president, BIOTRONIK U.S.

Evia is the first pacemaker in which all electronic components have been manufactured and tested with full automation, eliminating human touch and minimizing room for human error.

“BIOTRONIK is committed to developing and delivering products like Evia, because quality of life is paramount for patients,” Langer added.

Longevity – A new standard

The REPLACE Registry, sponsored by BIOTRONIK, is a multi-center analysis that quantified complication rates in device replacement procedures utilizing devices from all CRM industry manufacturers. The registry showed that one in 10 patients will suffer side effects and complications from device replacement. “By providing a decade of longevity with Evia, BIOTRONIK again has demonstrated its focus on patient-centric innovations,” stated Langer. “Evia’s new design provides a dramatic reduction in energy consumption. Replacement is safe for most patients, but we have minimized that small risk to a new standard.”

Small Device Delivers Wide Array of Therapy

Evia includes BIOTRONIK’s proprietary and proven Closed Loop Stimulation (CLS), which is the most advanced and physiologic rate regulation algorithm available on the market. CLS integrates into the natural cardiovascular loop by measuring changes in myocardial contraction dynamics and translating them into appropriate heart rate regulation, emulating a healthy sinus node, the human heart’s natural pacemaker. CLS is also the only rate regulation algorithm that is proven to pace effectively during periods of acute mental stress. Intrinsic Optimization (I-Opt), a one-button programming solution, optimizes AV delay with AV hysteresis (up to 400 ms) to minimize right ventricular pacing.

1. Varma N. et al. Evaluation of efficacy and safety of remote monitoring for ICD follow-up: the TRUST trial (abstract 4078). Circulation. 2008; 118;2316.

Source
BIOTRONIK

The U.S. Food and Drug Administration today approved the first medical device that uses radiofrequency energy to treat severe and persistent asthma in certain adults.

The Alair Bronchial Thermoplasty System is intended for patients ages 18 and older whose severe and persistent asthma is not well-controlled with inhaled corticosteroids and long-acting beta agonist medications.

The device is composed of a catheter with an electrode tip that delivers a form of electromagnetic energy, called radiofrequency energy, directly to the airways. A controller unit generates and controls the energy.

Inflammation causes the airways of people who have asthma to swell and narrow, making breathing difficult. The Alair system treats asthma symptoms by using radiofrequency energy to heat the lung tissue in a controlled manner, reducing the thickness of smooth muscle in the airways and improving a patient’s ability to breathe. To benefit, patients will require multiple sessions targeting different areas in the lungs.

“The approval of the Alair system provides adult patients suffering from severe and persistent asthma with an additional treatment option for a disease that is often difficult to manage,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

The FDA based its approval on data from a clinical trial of 297 patients with severe and persistent asthma. The trial showed a reduction of severe asthma attacks with use of the Alair system.

The FDA is requiring a five-year post-approval study of the device to study its long-term safety and effectiveness. The device manufacturer, Asthmatx, will follow many of the patients who were enrolled in the clinical trial and enroll 300 new patients at several medical centers across the United States.

Possible side effects during the course of treatment may include asthma attacks, wheezing, chest tightness or pain, partially collapsed lung (atelectasis), coughing up blood (hemoptysis), anxiety, headaches, and nausea. The Alair system is designed to reduce the number of severe asthma attacks on a long-term basis. However, there is a risk of immediate asthma attacks during the course of the treatment.

The Alair system is not for use in asthma patients with a pacemaker, internal defibrillator, or other implantable electronic device. Also, those patients with known sensitivities to lidocaine, atropine, or benzodiazepines should not use the device. Alair has not been studied for success in retreatment of the same area of the lung. Currently, patients should not be retreated with the Alair system in the same area of the lung.

Asthma patients considering the Alair system should not be treated while the following conditions are present: an active respiratory infection, coagulopathy (bleeding disorder), asthma exacerbations, or if they have had changes to their corticosteroid regimen 14 days before the proposed treatment.

Asthmatx Inc. is based in Sunnyvale, Calif.