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

Five engineering breakthroughs, from software for virtual surgery to an energy saving device that detects drafts, were cited today by IEEE-USA, the U.S. career and public policy unit of the IEEE, the world’s largest professional association for the advancement of technology.

The five breakthroughs, as included in television news reports recently distributed to almost 200 local U.S. TV stations, are:

1. “Doctors Playing Doctor,” in which biomedical engineers designed software that allows surgeons to perform a virtual surgery before entering the operating room
2. “Save Money: Cut Energy Costs,” in which engineers have designed a hand-held device that detects drafts around windows and doors
3. “Soldier Safety: Sniper-Detecting Helmet,” in which electrical engineers (EEs) have developed a system that allows a soldier’s combat helmet to determine the locations of enemy shooters and the type of weapons they are firing
4. “Can You Hear Me Now?,” in which EEs have designed a radio chip for communication devices that mimics the way the human ear absorbs sound
5. “‘Intelligent’ Tools Help Disabled,” in which artificial intelligence researchers have developed intelligent medical assistive devices that make mobility easier for patients

Source:
Pender M. McCarter

Terumo Medical Corporation, a U.S.-based subsidiary of Terumo Corporation, has announced it has received an investigational device exemption (IDE) conditional approval from the U.S. Food & Drug Administration (FDA) for its Occlusive/Stenotic Peripheral Artery Revascularization Study (OSPREY) in the U.S., which will evaluate the safety and effectiveness of the MISAGO™ Self-expanding Stent System for use in the superficial femoral artery (SFA). This marks the company’s first U.S. clinical trial for a premarket approval (PMA) device. A unique feature of the clinical trial is that it will simultaneously enroll patients in the U.S. and Japan. Referred to as “Medical Device Collaborative Consultation and Review of Premarketing Applications” under the larger “Harmonization by Doing” (HBD) initiative, Terumo’s trial was selected as one of two projects to pilot this approach, which is intended to shorten the gap between product approvals in these two significant world healthcare markets.

HBD is an international effort to develop global clinical trials and address regulatory barriers that may be impediments to timely device approvals. This process is a cooperative effort to move both Japan and the U.S. toward international regulatory harmonization. The HBD initiative is a pilot project launched in December 2003 that seeks regulatory convergence between FDA and MHLW-PMDA (Japan’s regulatory bodies). The learning obtained in the “proof of concept” trials will assist both regulatory bodies in streamlining the clinical trial process for faster approvals in both countries, as well as promote the idea of global trials for purposes of collecting better data. In this pilot HBD approach, the products will be submitted for review and approval at the same time.

“I believe this approach to shorten the time for new product approvals between the U.S. and Japan is critical and exciting,” said Takao Ohki, MD, Chairman and Professor, Department of Surgery, Jikei University School of Medicine, Division of Vascular Surgery, and the global principal investigator of the OSPREY trial. “This innovative movement could dramatically solve the current device lag issue between our countries.”

In the U.S., OSPREY is a single-arm, multi-center, non-randomized prospective clinical trial for the treatment of atherosclerotic stenoses and occlusions of the SFA. In Japan, there are two arms of the study, 50 patients receiving the MISAGO Stent and 50 patients receiving percutaneous transluminal angioplasty (PTA).

The primary endpoints of the U.S. study are:

• Primary stent patency rate at one year as confirmed by duplex ultrasound or angiography.
• Freedom from major adverse events within 30 days of the procedure, which would result in target lesion revascularization, amputation of the treated limb or death.

The study will include up to 350 patients, a maximum of 250 patients in up to 30 centers in the U.S. and 100 patients in Japan. There have already been six patients enrolled in Japan, which received regulatory approval to begin the trial last year. The first U.S. enrollments are expected in June 2010. The U.S. principal investigator is J. Fritz Angle, MD, Associate Professor of Radiology, University of Virginia.

“Peripheral vascular disease management continues to be a major clinical problem,” said Dr. Angle. “We need better tools to improve revascularization of femoral-popliteal vessels. I applaud Terumo’s efforts to advance this field.”

The MISAGO Self-expanding Stent consists of a nitinol stent pre-mounted on the distal portion of a rapid-exchange delivery catheter system. The stent has three radiopaque markers located on each end of the stent to help ensure accurate placement in the lesion. The stent is currently available for sale in Europe.

“We are eager to move forward with the first harmonized clinical trial in the U.S. and Japan,” said Juichi (Jim) Takeuchi, President and CEO, Terumo Medical Corporation. “We are not only proud of the MISAGO Stent, but also of Terumo’s selection to participate in this precedent-setting international collaborative effort between regulators, industry, clinical researchers, patients, and academia. We look forward to initiating our first PMA clinical trial in the United States and to bringing innovative new interventional technology to market to improve patients’ quality of life.”

Source:
Robert Murphy
The Storch Murphy Group

Medtronic, Inc. (NYSE: MDT) announced today that it now offers the new Medtronic M-Link™ cellular accessory, which provides cardiac device patients with an option to securely send information stored in their implanted devices to their clinics via the CareLink® Network using cellular signals, rather than a telephone landline. This simplified connection to the CareLink® Network enables clinicians to remotely monitor more patients who are implanted with cardiac devices.

“The M-Link cellular accessory is making remote monitoring accessible to a greater number of eligible patients,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic. “Now patients without a telephone landline have a convenient option to access the CareLink Network and take advantage of the benefits that come with remote monitoring, including fewer in-clinic visits and peace of mind from knowing their device data can be transmitted using cellular technology, without the need for a landline.”

The introduction of the M-Link cellular accessory comes on the heels of a landmark study showcasing the benefits of remote monitoring for patients and their physicians. Results from Medtronic’s CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) trial presented at the American College of Cardiology Scientific Sessions in March 2010 showed cardiac resynchronization therapy-defibrillator (CRT-D) and implantable cardioverter-defibrillator (ICD) patients monitored through the CareLink Network experienced a significant reduction in time from clinical event to clinical decision and also benefitted from shorter hospital stays and reduced costs per hospitalization.

The M-Link cellular accessory provides patients with a convenient option to stay connected with their clinic from home, work, or while traveling globally. The M-Link cellular accessory securely connects to any CareLink Patient Monitor and allows patients to transmit data from their implanted device directly to their clinic through the secure CareLink Network. It also allows Medtronic CareAlert® Notifications to be transmitted when any of the programmable alert conditions from a patient’s implanted device has occurred. Physicians and nurses can view the transmitted data through a secure Web site, giving them the opportunity for a “real-time” look at how the patient’s device is functioning. The information transmitted is comparable to that provided during an in-clinic device follow-up visit.

Medtronic will showcase the M-Link cellular accessory as well as its portfolio of patient management and connectivity tools that simplify a clinician’s workday at Heart Rhythm 2010 in Denver, May 12-15, 2010 (booth 503). Also, showcasing the depth and breadth of data collected through Medtronic’s CareLink Network, four poster sessions and one late-breaking clinical trial will be presented at Heart Rhythm 2010 based on aggregate, de-identified data garnered exclusively through the CareLink Network.

About the Medtronic CareLink Network

The Medtronic CareLink Network is the world’s largest and most widely used remote monitoring system for implantable cardiac device patients, with more than 4,000 clinics and 500,000 patients enrolled in 30 countries. The CareLink Network has registered more than 2 million patient data transmissions since the service’s inception in 2002.

The CareLink Network provides the most flexible alert system in the industry that offers customizable and color-coded alert notifications for devices with Conexus® Wireless Telemetry. Through this network, patient data are transmitted from their implanted device using a portable monitor through cellular signals or a standard telephone line. Within minutes, the patient’s physician and nurses can view the data on a secure Internet Web site. Available information includes, but is not limited to, arrhythmia episode reports and stored electrograms along with device integrity information.

Source
Medtronic

Covidien (NYSE: COV), a leading global provider of healthcare products and recognized innovator in mechanical ventilation, announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the Puritan Bennett™ 840 ventilator’s minimum delivered tidal volume down to 2 mL. This feature will enable the Puritan Bennett 840 ventilator to provide ventilatory support for neonates weighing as little as 300 grams.

The Puritan Bennett 840 ventilator delivers a comprehensive, user-friendly solution offering ventilation for a broad range of patients and acuity levels, from neonates to adults. Multiple therapies of ventilation help clinicians respond with the most appropriate ventilation strategy, including a neonatal continuous positive airway pressure (CPAP) mode, enabling noninvasive ventilation in neonates.

The ability to deliver a minimum tidal volume of 2mL will enable clinicians to safely ventilate the smallest and most critically ill neonatal patients with the Puritan Bennett 840 ventilator. This feature will complement recent enhancements to the Puritan Bennett™ 840 NeoMode™ software, including neonatal CPAP mode and the ability to increase the fraction of inspired oxygen (FiO2) by 20% for up to two minutes during suctioning. An increased FiO2 is necessary to manage adequate oxygenation in patients who are critically ill.

“This FDA 510(k) clearance allows Covidien to make clinicians aware that one device, the Puritan Bennett 840 ventilator, can be used on all patients from newborn to adults,” said Douglas Hansell, M.D., M.P.H., Chief Medical Officer and Vice President, Respiratory and Monitoring Solutions, Covidien. “Now patients, from the smallest neonates in the NICU through adults in the ICU, can receive the clinical benefits provided by the Puritan Bennett 840 ventilator.”

Source
Covidien

Diazyme Laboratories announced today that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(k) clearance to market its SMART HbA1c Assay on its new SMART Point of Care System for diabetes monitoring. The SMART HbA1c Assay offers rapid testing capabilities and is based on Diazyme’s proprietary Direct Enzymatic HbA1c assay technology.

The assay can be run from a simple finger stick blood sample obtained in a physician’s office and delivers accurate and reliable results in minutes. Unlike other point of care systems for HbA1c, the Diazyme SMART HbA1c Assay has been shown to have no interference from common hemoglobin variants including Hb E, Hb C, Hb S and Hb D traits. This means the assay offers freedom from interference in HbA1c testing, which is of special importance today as the HbA1c test is now considered the key test for diagnosis and screening of diabetic disease.

“Diazyme’s new SMART HbA1c Assay provides a convenient and cost effective test method which will benefit laboratories, physicians and the patients they care for,” said Dr. Chong Yuan, Managing Director of Diazyme Laboratories. In addition to HbA1c, the SMART Point of Care System offers the capability to run tests for monitoring renal function as well as cardiac risk assessment. Additional assays in development for the SMART Point of Care System include Cystatin C, which has been shown to be a more reliable marker than creatinine for early detection of acute and chronic kidney disease, and Enzymatic Homocysteine and high sensitivity hsCRP, both of which are important biomarkers for cardiac and stroke risk assessment.

Source
Diazyme Laboratories

The U.S. Food and Drug Administration sent a letter to Baxter Healthcare Corp. on April 30 ordering the company to recall and destroy all of its Colleague Volumetric Infusion Pumps (Colleague pumps) currently in use in the United States. This action is based on a longstanding failure to correct many serious problems with the pumps. The FDA believes there may be as many as 200,000 of those pumps currently in use.

Additionally, the FDA is ordering the company to provide refunds to customers or replace pumps at no cost to customers help defray the cost of replacement.

Infusion pumps are devices that deliver fluids, including nutrients and medications, into a patient’s body in a controlled manner. They are widely used in hospitals, other clinical settings and, increasingly, in the home because they allow a greater level of accuracy in fluid delivery.

Hospitals and other users of Baxter’s Colleague pumps will be receiving further instruction and information from Baxter and the FDA regarding their transition.

The FDA has been working with Baxter since 1999 to correct numerous device flaws. Since then, Colleague pumps have been the subject of several Class I recalls for battery swelling, inadvertent power off, service data errors, and other issues.
In June 2006, the FDA was obtained a consent decree of permanent injunction in which Baxter agreed to stop manufacturing and distributing all models of the Colleague pump until the company corrected manufacturing deficiencies and until devices in use were brought into compliance. Since then, Baxter has made numerous changes to the Colleague pumps but these changes have not corrected the product defect leading to the permanent injunction.

On April 8, 2010, Baxter submitted a proposed correction schedule to the FDA that stated that Baxter did not plan to begin the latest round of corrections to the adulterated and misbranded pumps until May 2012. The proposal also stated that Baxter does not anticipate completion of the proposed corrections until 2013. On that schedule, a device with known safety concerns would remain in use on patients needing specialized care until 2013. FDA found this proposal unacceptable. The 2006 consent decree gave FDA authority to take any action it deemed appropriate. The FDA has determined that this action is necessary, as Baxter has failed to adequately correct, within a reasonable timeframe, the deficiencies in the Colleague infusion pumps still in use.

Therefore the FDA is now ordering Baxter to:

• Recall and destroy all Colleague infusion pumps.
• Reimburse customers for the value of the recalled device
• Assist in finding a replacement for these customers.

Infusion pumps, including the Baxter Colleague models, have been the source of persistent safety problems. In the past five years, the FDA has received more than 56,000 reports of adverse events associated with the use of infusion pumps. Those events have included serious injuries and more than 500 deaths. Between 2005 and 2009, 87 infusion pump recalls were conducted to address identified safety concerns, according to FDA data.

An FDA analysis of these adverse events has uncovered software defects, user interface problems and mechanical and electrical failures. Problems with infusion pumps are not confined to one manufacturer or one type of device.
In response, last month the FDA announced a new initiative to address safety problems associated with infusion pumps. As part of its initiative, the FDA is moving to establish additional premarket requirements manufacturers will be expected to meet, in part through static testing in FDA’s facilities before device submissions. The FDA is also holding a May public workshop on infusion pump design, and the agency is raising public awareness of the issue among health care workers and patients.