Leadless Cardiac Pacemaker – New Tech For Health

A totally self-contained, lead-less pacemaker (Nanostim, Pacesetter, Inc./St. Jude Medical, USA) has been shown to be safe and effective in 33 patients with an indication for single (right) ventricle pacing. It is a lead-less cardiac pacemakers experimental and investigational for arrhythmia and all other indications because of insufficient evidence of its safety and effectiveness.

Lead-less pacemakers are designed to achieve the same pacing results as a standard pacemaker, but the process for implanting the lead-less pacemaker is different from standard pacemakers. The lead-less pacemaker is placed via a catheter into the right ventricle. Unlike a standard pacemaker, a lead-less pacemaker does not require creation of a surgical pocket for the pacemaker, and it requires no leads. The pacemaker battery life is equivalent to that of similar standard single chamber pacemakers.

The primary safety end point was freedom from complications at 90 days. Secondary performance end points included implant success rate, implant time, and measures of device performance (pacing/sensing thresholds and rate-responsive performance). The mean age of the patient cohort (n=33) was 77±8 years, and 67% of the patients were male (n=22/33). The most common indication for cardiac pacing was permanent atrial fibrillation with auriculoventricular block (n=22, 67%). The implant success rate was 97% (n=32). Five patients (15%) required the use of >1 lead-less cardiac pacemaker during the procedure. One patient developed right ventricular perforation and cardiac tamponage during the implant procedure, and eventually died as the result of a stroke. The overall complication-free rate was 94% (31/33). After 3 months of follow-up, the measures of pacing performance (sensing, impedance, and pacing threshold) either improved or were stable within the accepted range.

Acknowledgement: The speaking panel acknowledge Radcliffe Cardiology for providing writing and editorial support.

Keywords: 

Lead-less pacemaker, cardiac arrhythmias, pacemaker-related complications, surgical pocket, venous thrombosis

A lead-less cardiac pacemaker system is a pulse generator with built-in battery and electrode for implantation in a cardiac chamber via a transferal catheter approach.

Additional studies are necessary to evaluate the safety, efficacy and stability of lead-less pacemakers.

Telescope In Contact Lens It Could Help People With Blinding Disease.

Lights, mirrors, action! Scientists are developing smart contact lenses embedded with miniscule mirrors that can magnify your vision by almost three times.

telescope-contact-lens

The 1.55mm-thick lenses incorporate a thin reflective telescope made of mirrors and filters; when light enters the eye it bounces off the series of mirrors and increases the perceived view of an object or person. It is hoped that the lens will improve the sight of people with age-related macular degeneration (AMD) — the third leading cause of blindness globally.

AMD causes the loss of central vision due to gradual damage to the eye’s retina and there are few options for cure or treatment. “AMD is the biggest problem where magnification is a proven visual aid,” says Eric Tremblay, research scientist at EPFL in Switzerland.

Tremblay led the optical design of the lens, which is based on a surgically implantable telescope currently used by some patients with AMD, but which is more invasive than a lens. “With a contact lens, it’s easy to try it,” says Tremblay.

Making the switch

A key innovation with the lenses is the added ability to switch between magnified and regular vision through a complementary pair of glasses. The battery-powered glasses use LCD technology to watch the movement of the eye and a simple wink can alter their polarization and determine whether light entering is magnified or not. “Having the ability to switch on demand is attractive,” says Tremblay.

The ability to selectively magnify your vision makes the design of the glass-lens combination more suitable for daily life. “When magnified you lose a lot of your field of view, your peripheral vision,” says Tremblay. A strategic wink will enable users to keep an eye on their periphery, such as cars approaching them as they cross a street, whilst also being able to zoom in and recognize the faces of those around them.

The team developed their technology on scleral lenses, which have an increased thickness and diameter, making them commonly used for more special purpose eye care. “[They provide] a lot more area to work with,” says Tremblay. The challenge these lenses bring with them, however, is comfort, as they impede the amount of oxygen reaching the eye.

The most recent prototype, unveiled by the team in February, overcame this challenge by introducing air channels to aid the flow of oxygen to the eye. But the team hopes to improve this further still by instead developing a contact lens solution saturated with oxygen which can be stored and slowly released into the eye. “[We will] build reservoirs into the back of the lens,” says Tremblay.

The lenses have only been trialled on a handful of humans to test for comfort, with the majority of research to date performed in the lab using a model chemical eye. But more human trials are on the cards with the eventual goal of daily wearable contacts to aid the visually impaired.

“We want it to move in the direction of a real world vision aid,” says Tremblay.

Getting smarter

These are not the first smart contact lenses. Other prototypes have been developed to monitor, as well as improve, health in both the eye and across the body.

Alcon, the eye care division of Novartis, formed a partnership with Google X in 2014 to develop smart-lens technologies for a range of medical eye care applications. One of the first examples of using lenses in this form was Sensimed, a spin-off also emerging from EPFL. Sensimed’s Triggerfish technology monitors the progression of glaucoma — the second leading cause of blindness, affecting more than 4.5 million people globally.

Glaucoma is a progressive cause of blindness caused by deterioration of the eye’s optic nerve. The traditional test used by optometrists to monitor patients uses puffs of air to measure pressure in the eye but such measurements are not ideal.

“The big need in glaucoma is for a 24-hour picture of what’s happening inside the eye,” says David Bailey, CEO of Sensimed. Its smart lens uses strain gauges and sensors embedded inside a chip located in the lens to measure changes in the volume of liquid in the eye as a surrogate measurement of pressure. It can be worn over a 24-hour period to monitor pressure patterns and communicate data wirelessly to a recording device worn around the user’s neck.

Optomotrist James Wolffsohn, spokesperson for the British Contact Lens Association, looks forward to one day using technologies like the telescopic lens in clinical practice. “The lens seems an interesting concept to provide optical magnification to the retina when required,” he says. But he adds that there will be challenges in reaching that stage: “It is currently a scleral lens and thick, including rigid mirror elements which are likely to affect corneal physiology and comfort.” Wolffsohn has seen colleagues trial the more established Triggerfish technology to monitor glaucoma and is optimistic about the future of the field. “There are also many other exciting developments in innovative uses of contact lenses,” he says.

“The eye is the window to many disease states,” says Bailey, who believes contact lenses are the future for eye care, both in terms of clinical use and lifestyle management. More than 30 million people wear contact lenses in the United States alone, according to the Centers for Disease Control, which means they could be a non-invasive path to health management — be it blindness progression or even insulin or alcohol level monitoring.

Spineology Announces Release of a Next Generation Spinous Process Fixation System

Spineology Inc., the innovator in anatomy conserving spine surgery, is excited to announce the full release of its VIA Spinous Process Fixation System.

“The implant and instrumentation help preserve patient anatomy and limit operating room time which follows Spineology’s anatomy conserving design philosophy. The system will be a great addition to our product line.”

VIA is the first and only Spinous Process Plate with independently compressible superior and inferior plates that are contoured to maximize the fit between the implant and the spinous processes and associated laminae.

“Our goal in developing the VIA Spinous Process Fixation System was to offer versatility beyond that of existing systems on the market,” said Karen Roche, vice president of R&D for Spineology told Surgical Blog. “The independently compressible plates accommodate varying spinous process widths and allow for fixation on each spinous process independent of fixation on the adjacent spinous process, maximizing teeth engagement. The anatomically contoured design allows the device to fit the contour of the spinous processes and laminae, utilizing the strength of the latter.”

“VIA is the most recent addition to Spineology’s Anatomy Conserving Technology (ACTTM) product platform,” said John Booth, CEO for Spineology. “The implant and instrumentation help preserve patient anatomy and limit operating room time which follows Spineology’s anatomy conserving design philosophy. The system will be a great addition to our product line.”

Bayer Receives EU Approval For EYLEA In Diabetic Macular Edema

Bayer HealthCare announced today that EYLEA (aflibercept solution for injection into the eye) has been approved by the European Commission for the treatment of visual impairment due to diabetic macular edema (DME). Bayer plans for an immediate roll-out with Germany being one of the first launch countries in Europe.

“The approval of EYLEA in Europe in this important indication is great news for the increasing number of patients suffering from visual impairment due to DME,” said Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development. “This is an important step that further demonstrates our commitment in ophthalmology to bring new treatment options to patients suffering from serious ophthalmologic conditions.”

“The results of two phase 3 studies were very encouraging with the majority of patients with visual impairment due to diabetic macular edema experiencing a significant two-line improvement in visual acuity with aflibercept solution for injection,” said Prof. Jean-Francois Korobelnik, Principal Investigator of the VIVID-DME trial and Chief of Ophthalmology, CHU Bordeaux. “Early diagnosis of DME is critical, and if not treated rigorously, there is a high risk of DME leading to blindness.”

EYLEA has been approved in many countries for the treatment of neovascular age-related macular degeneration (wet AMD) and for the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO). Regulatory submissions have been made in Asia Pacific including Japan and Latin America for the treatment of DME. In Japan, EYLEA has been additionally submitted for approval to regulators for the treatment of choroidal neovascularization secondary to pathologic myopia (mCNV). Furthermore a regulatory submission has been made in Europe and the U.S. for EYLEA for the treatment of visual impairment due to macular edema following branch retinal vein occlusion.

Bayer HealthCare and Regeneron Pharmaceuticals, Inc. are collaborating on the global development of EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States. Bayer HealthCare has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of EYLEA, except for Japan where Regeneron receives a percentage of net sales.

Breg Introduces Knee Brace To Help Runners With Patellofemoral Pain Syndrome

Breg, Inc., a premier provider of sports medicine products and services, has launched the FreeRunner™ knee brace with new innovations to help people, particularly runners, who suffer from patella mal-tracking return to active lifestyles.  FreeRunner’s patent-pending design acts on knee anatomy differently than other braces, providing support when patients need it most, and the ability to move normally when they don’t.

Patellofemoral issues are the most common cause of knee pain seen by health care providers.1 In fact, more than 2.5 million runners are diagnosed with patellofemoral pain syndrome every year.2  It is typically caused by overuse, injury, excess weight, muscle imbalance or a knee cap that is misaligned. Common examples of patella mal-tracking are patella dislocation, runner’s knee and patellar tendonitis, among other conditions.

“Working with Breg on this brace is my first experience with a manufacturer partnering with clinicians to design a better product,” said Jill Monson, PT, OCS, CSCS, Monson Orthopaedic Consulting, LLC. “The team really listened to relevant clinical needs and goals of patients, and helped develop a brace design rooted in known patellofemoral joint biomechanics.”

Unlike other patellofemoral braces, FreeRunner provides maximum stabilization of the patella when the leg is extended, helping to keep the knee cap in place when it is most vulnerable to mal-tracking or dislocation. The brace offloads pressure when the leg is bent in flexion and the patella is not as unstable. This allows freedom of movement without sacrificing support.

“Patellofemoral braces have not changed much in the last 20 years,” said Brad Lee, president and CEO, Breg. “Our new FreeRunner challenges the outdated way of bracing these conditions. It is highly functional, comfortable and non-binding during activity. We set out to make a brace that works and people want to wear.  We believe we’ve achieved that goal.”

At just 7 ounces, FreeRunner is lightweight and low profile for minimal interference during activities. The brace incorporates new, breathable Smart-Zone™ compression fabrics that direct moderate compression for anatomic support where needed, and light compression over the patella and the popliteal space at the back of the knee for a non-binding fit.

Siemens Announces FDA Clearance Of Artis One Angiography System

Siemens Healthcare has announced that the U.S. Food and Drug Administration (FDA) has cleared the Artis one – an angiography system optimized for broad clinical utilization. The Artis one is designed for routine interventions, including revascularizations of peripheral vessel occlusions, functional tests of dialysis shunts in patients with kidney failure, diagnostic or minimally invasive angiographic treatment of narrowed coronary arteries, and pacemaker implantations.

Flexible with low space requirement

Despite being floor-mounted, the Artis one enjoys a positioning flexibility similar to ceiling-mounted systems and occupies just 269 square feet, compared to the standard 484 square feet required by ceiling-mounted systems. The system features several axes that can move independently of one other, enabling physicians and hospital staff to easily position the system where needed – regardless of where they stand. It accommodates full head-to-toe coverage of patients up to 6 feet, 10 inches without the need for patient repositioning. The system allows free access to the patient’s head, enabling optimal care during the procedure.

Tactile buttons on the Artis one’s tableside console can be manipulated easily even under the sterile covering. The system’s on-screen, menu-guided user interface allows the physician to navigate directly using the heads-up display. All information regarding the procedure remains directly in front of the operator. The Artis one’s 30-inch display size delivers images up to 90 percent larger than conventional 19-inch monitors.

Premium cardio applications, powerful X-ray tube

Artis one’s Clearstent Live application for interventional cardiology procedures – previously available only with Siemens’ premium family Artis Q and Artis Q.zen – freezes motion in the region of the stent, allowing the physician to mask out movement of the beating heart and place the stent in precisely the correct position. The Artis one also offers new tools for cardiac imaging, including HeartSweep, which uses dual-axis rotational angiography to image the entire heart in a single, smooth C-arm movement instead of multiple acquisitions from different projections. This single-sweep movement has the potential to speed up procedures and save contrast agents.¹ By utilizing 20 percent less energy than Siemens’ Artis zee floor system, the Artis one also helps reduce operational costs. This feat is achieved primarily through components manufactured by Siemens for industry automation.

The Artis one angiography system is available in multiple configurations that are tailored to fit a broad range of clinical requirements.

¹ This is the experience of individual users. Results may vary.

Siemens Showcases New Clinical Diagnostics Solutions At IFCC WorldLab 2014

Siemens Healthcare today unveils its latest in vitro diagnostics innovations during the IFCC WorldLab 2014 in Istanbul, Turkey, June 22-26. Visitors to the Siemens exhibit – themed “Test smarter. Run faster.” – can explore Siemens’ portfolio of solutions, including new central laboratory clinical analyzers designed to help customers meet growing workload demands, a next-generation drug testing platform, enhanced informatics capabilities and coagulation testing for use at the point of care.

“At Siemens, we understand the critical role that in vitro diagnostic (IVD) testing plays in the lives of patients and their families,” said Michael Reitermann, CEO, Siemens Healthcare, Diagnostics Division. “This year’s IFCC WorldLab provides an excellent platform to demonstrate how our products and services, regardless of where testing takes place, deliver clinical excellence and workflow solutions that can ultimately enable better patient care.”

New Testing, Automation and IT Offerings for the Central Lab

This year, Siemens is showcasing its latest advancements in central laboratory testing, including the ADVIA Chemistry XPT System1 and ADVIA Centaur XPT Immunoassay System1. These new clinical systems are designed to enhance workflow and streamline processes to help customers quickly, reliably and cost-effectively meet ever-increasing workload demands. For example, the systems offer new user interfaces, large touchscreens and remote service diagnostics to support easy operations. Also, each system features versatile technology enabling a broad range of testing that support clinicians in the screening, diagnosing and monitoring of the most complex diseases.

In addition, both the ADVIA Chemistry XPT System and ADVIA Centaur XPT Immunoassay System have enhanced data management capability with Siemens’ CentraLink Data Management System2 and connect to Aptio Automation2, the company’s latest track-based automation system. Booth visitors can explore Aptio Automation, including the new Tube Inspection Module2, which helps labs reduce pre-analytical errors and minimize the risk for tube mismatch, as well as featured multidisciplinary connectivity options including Sysmex CS-5100 Hemostasis System2 and ADVIA 2120i Hematology System.

Siemens is also introducing the CentraLink Data Management System Version 15, with the optional Advanced Hematology Module1. This hematology module enables labs to automate the hematology workflow resulting in reduced manual steps and increased efficiency. In addition, this latest version of the CentraLink System includes enhancements in quality control and customization to further enhance test result accuracy and enable healthcare organizations to increase productivity while reducing costs.

Experts will be on hand to discuss Siemens’ drug testing solutions, including the new Viva-ProE System1, a next generation drug-testing platform with intuitive software and enhanced components designed to lower operating costs while delivering reliable results.

Testing and Workflow Innovations at the Point of Care

With the growing demand for near-patient testing, Siemens is also showcasing its latest instruments and workflow innovations for use at the point of care (POC). This includes the Xprecia Stride Coagulation Analyzer1, a handheld coagulation system designed to perform prothrombin time testing (PT/INR).

Visitors to the booth can also learn about enhanced capabilities now offered by the RAPIDComm Data Management System2, the company’s POC informatics solution. With upgraded software, the RAPIDComm Data Management System now supports the new RAPIDComm Web Application, which allows POC coordinators, via a handheld device, to view instrument status, troubleshoot issues, and remotely manage blood gas instruments. The new software enables an interface to Siemens PEP (Personalized Education Plan) Administrator, an innovative web-based software that helps to simplify and streamline administration or staff education and training programs. With these features, the RAPIDComm Data Management System fully supports an ecosystem approach to POC testing, which encompasses device and operator management, quality control (QC), compliance reporting, competency management, inventory management, remote monitoring and mobile access.

Additionally on display is the RAPIDLab 348EX Blood Gas System2, a cost-effective solution for the measurement of pH, oxygen, carbon dioxide, electrolytes and hematocrit designed for the low-volume laboratory settings. The RAPIDLab 348EX Blood Gas System accurately delivers actionable patient test results in approximately 60 seconds on as little as 50 µL of whole blood.

Toshiba’s New Cardiovascular X-ray System – Infinix Essential

Hospitals are now able to address their interventional cardiology needs with Toshiba America Medical Systems, Inc.’s newest X-ray system, the InfinixTM Essential. As healthcare reform challenges hospitals to do more with less, the Infinix Essential is an ideal value system that doesn’t sacrifice performance. With its slim, off-center C-arm design, the system allows steep angulations for optimized vessel profiling during cardiac interventions.

Featuring Toshiba’s revolutionary C-arm design and WorkRite technology, Infinix Essential provides unprecedented access and coverage during interventional cardiac procedures. As facilities grow, they can add advanced features to their system to perform procedures such as TAVR or left atrium appendage closures. Based on Toshiba’s commitment to achieve the highest image quality at the lowest possible dose on all systems, Infinix Essential is available with a comprehensive set of dose management optimizing tools, including Spot Fluoroscopy, Dose Tracking System (DTS) and Advanced Image Processing (AIP).

“Reform requires hospitals to provide the same standard of care with fewer resources, and Toshiba is responding to these changes by introducing the Infinix Essential,” said David Sloop, director, X-ray Vascular Business Unit, Toshiba. “Toshiba’s entire Infinix product line is designed to provide our customers with the right technology for better patient care and the new business environment.”

In addition to the launch of the Infinix Essential, Toshiba is repositioning its line of existing cardiovascular X-ray systems to meet the needs of providers during healthcare reform. Toshiba’s Infinix Select is a shared lab solution with two differently sized, independent flat panel detectors that can perform a range of both simple and sophisticated cardiac and vascular procedures. For customers in need of a full cardiovascular lab to conduct the most advanced procedures, the Infinix Elite is available in multiple configurations and with Toshiba’s revolutionary five-axis C-arm, which provides head-to-toe and fingertip-to-fingertip coverage.

These systems are available with Toshiba’s numerous dose reduction technologies and recently FDA-cleared software upgrade, for improved and expanded imaging applications.