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

Xlumena, a privately held provider of innovative technology for gastroenterologists/interventional endoscopists, announced it has received clearance from the US Food and Drug Administration (FDA) to market its NAVIX™ Access Device. The NAVIX™ Device is an advanced endoscopy system, consisting of a multi-lumen catheter with a trocar, anchor and dilation balloons and two guidewire ports, designed to enable secure access, dilation and delivery of guidewires for pseudocyst and abscess drainage procedures.

“We are pleased to introduce the NAVIX™ Access Device, the first in a line of revolutionary products under development, based on Xlumena’s Advanced Translumenal Therapy™ technology,” said Michael Allen, President and CEO of Xlumena. “We believe this is an important first step in providing the interventional endoscopist with innovative tools that will enable a broader reach within the specialty and take interventional endoscopy to a new therapeutic level.”

Kenneth Binmoeller, M.D., Medical Director at the Interventional Endoscopy Center at California Pacific Medical Center in San Francisco, Calif. added: “Xlumena has accurately identified some of the technical challenges, the interventional endoscopists are struggling with, and is developing simple, elegant solutions with products such as the NAVIX™ Access Device.

Xlumena will initially make the NAVIX™ Access Device available to a select number of interventional endoscopy centers across the US. The clearance follows the Xlumena AXIOS™ translumenal gallbladder stent and delivery system receiving a humanitarian use designation by the FDA. FDA clearance for the AXIOS™ stent and delivery system is pending.

Xlumena will host a Tech Suite at the Digestive Diseases Week (DDW) meeting in New Orleans, LA on May 2-6, 2010 to showcase the NAVIX™ and other Advanced Translumenal Therapy™ platforms to invited partners and physicians.

Source: Xlumena, Inc