Stryker robotic-arm can assist hip or knee replacement

Photo: Stryker

Stryker Corporation announced the commercial launch of the highly anticipated robotic-arm assisted total knee arthroplasty application for use with its Mako System at the American Academy of Orthopaedic Surgeons (AAOS) annual meeting in San Diego. This latest advancement distinguishes the Mako System as the first and only robotic technology that can be used across the joint replacement service line to perform total knee, total hip and partial knee replacements.

Mako Total Knee combines Stryker’s advanced robotic technology with its clinically proven Triathlon Total Knee System (“GetAroundKnee”), enabling surgeons to have a more predictable surgical experience with increased accuracy.1 Through CT-based 3D modeling of bone anatomy, surgeons can use the Mako System to create a personalized surgical plan and identify the implant size, orientation and alignment based on each patient’s unique anatomy. The Mako System also enables surgeons to virtually modify the surgical plan intra-operatively and assists the surgeon in executing bone resections.

Total knee replacements in the United States are expected to increase 673 percent by 2030,2 yet studies have shown that approximately 30 percent of patients are dissatisfied after conventional surgery.3 As this procedural growth materializes, surgeons will continue to seek clinical solutions that leverage technological advancements to improve their patient’s satisfaction.

“We are excited to be leading the transformation of the orthopaedics industry with the commercial launch of the Mako Total Knee application,” said Bill Huffnagle, President of Stryker’s Joint Replacement Division. “We believe that pairing our Mako robotic-arm technology with our market leading implant systems will enable surgeons to have an improved surgical experience.”

More than 83,000 Mako robotic-arm assisted procedures, including total knee, partial knee and total hip replacements, have been performed through 2016.  More than 350 Mako Systems have been placed in the United States with over 1,400 Mako Total Knee replacements performed to date.

Source: Stryker

FDA Approved Medtronic Insertable Cardiac Monitor

Photo: Medtronic

Medtronic announced U.S. Food and Drug Administration (FDA) 510(k) clearance for its Reveal LINQ(TM) Insertable Cardiac Monitor (ICM) with TruRhythm(TM) Detection, an advanced cardiac monitor offering improved accuracy to better identify abnormal heartbeats.

Reveal LINQ ICM with TruRhythm Detection offers exclusive algorithms that result in a 95 percent reduction in false bradycardia (slow heartbeat) episodes and a 47 percent reduction in false pause (brief absence of cardiac activity) episodes when compared with its predecessor, the Reveal LINQ(TM) ICM. The device also features a self-learning atrial fibrillation (AF – an irregular and often very fast heart rate) algorithm, which learns and adapts to a patient’s heart rhythm over time.  AF episodes, which are most likely to trigger false positives with ICMs, experienced a 49 percent reduction in false detections with the Reveal LINQ ICM with TruRhythm Detection when compared to the Reveal LINQ ICM.

“ICMs help physicians find answers for patients at risk for cardiac arrhythmias to better manage a range of patient populations,” said James Allred, M.D., electrophysiologist at Cone Health Medical Group Heartcare in Greensboro, N.C. “The enhancements with the Reveal LINQ ICM with TruRhythm Detection make it smarter by streamlining device data review so physicians can make decisions more accurately and quickly for patients.”

Reveal LINQ ICM with TruRhythm Detection, which allows physicians to continuously and wirelessly monitor a patient’s heartbeat for up to three years, is approximately one-third the size of an AAA battery (~1 cc). It is placed just beneath the skin through a small incision of less than 1 cm in the upper left side of the chest, using a minimally invasive procedure, and its presence is often nearly undetectable to the naked eye once the incision has healed. The device communicates wirelessly with a patient bedside monitor that uploads device data to the Medtronic CareLink® network; it is MR-Conditional, allowing patients to undergo magnetic resonance imaging (MRI), if needed.

“For nearly twenty years, Medtronic has led innovation in cardiac monitoring, including Reveal(TM), the world’s first loop recorder, and Reveal LINQ, the world’s smallest ICM,” said Nina Goodheart, vice president and general manager of the Patient Monitoring & Diagnostics business at Medtronic. “We collaborated with hundreds of clinicians and analyzed more than 50,000 ECGs allowing us to pinpoint how we could redesign our algorithms to improve detection specificity, without compromising sensitivity.”

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.

Source: Medtronic

Myriad Genetics launches early stage breast cancer test in US

Myriad Genetics announced that it has launched the EndoPredict® test in the United States for patients with ER+ HER2- early-stage breast cancer.  EndoPredict is a second-generation test for assessing the 10-year risk of disease recurrence following surgery and for determining which patients can safely forgo adjuvant chemotherapy.

“Today’s launch strengthens our oncology product portfolio and represents a meaningful advancement in the treatment of patients with breast cancer,” said Lloyd Sanders, general manager, Oncology, Myriad Genetic Laboratories.  “Along with our best-in-class tests for hereditary cancer and our companion diagnostics, the launch of EndoPredict underscores our commitment to pioneering science, personalized medicine and patient care.”

EndoPredict is supported by multiple prospective clinical studies and data from more than 3,500 patients with ER+ HER2- node negative and node positive early-stage breast cancer.  The results of the clinical development program show that EndoPredict substantially outperforms the first generation breast cancer recurrence tests.  EndoPredict was trained and validated using 10-year outcomes data and includes proliferation-related genes as well as hormone receptor-related genes, providing accurate assessment of early and late risk for recurrence and definitively classifies patients as low or high risk.

“Breast cancer is a complicated disease and there is a critical need for accurate breast cancer recurrence tests that help physicians determine which patients can safely forgo adjuvant chemotherapy,” said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetic Laboratories.  “The launch of EndoPredict is an important advancement for patients and doctors.  By automatically incorporating clinical features and generating an individualized patient test result, EndoPredict identifies a larger subset of true low-risk patients who may safely forgo adjuvant chemotherapy.”

EndoPredict already is included in medical guidelines including the American Society of Clinical Oncology (ASCO), European Society of Medical Oncology (ESMO) and the St. Gallen International Breast Conference.  Additionally, the Integrated Oncology Network (ION) named EndoPredict as its preferred breast cancer recurrence test.  Myriad is working with payers to making sure EndoPredict is a widely accessible to patients.  So far, the test has received positive coverage decisions from 19 payers, bringing total coverage to over 70 million patients in the United States.

Source: Myriad Genetics

ViewRay MRI-guided radiation therapy system FDA cleared

Photo: ViewRay

ViewRay, Inc. announced that the company received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the MRIdian Linac system, the company’s next generation linear accelerator-based MRI-guided radiation therapy system.

“FDA clearance of the MRIdian Linac is a transformative milestone for ViewRay,” said Chris A. Raanes, president and chief executive officer of ViewRay. “We believe that availability of the world’s first commercial system to combine MRI for soft-tissue visualization and a compact linear accelerator will lead to a new standard of care in radiation oncology. Clinical experience with ViewRay’s first generation MRIdian System has demonstrated the benefits of on-table adaptive therapy and real-time MRI guidance, as clinicians are seeing for the first time how much tumors and organs move and change shape during the course of treatment.”

The first two MRIdian Linac systems in the United States are expected to be installed at Henry Ford Hospital in Detroit and Barnes-Jewish Hospital at Washington University in St. Louis.

“Radiation oncologists have long awaited the availability of a clinical system that integrates MR-imaging with linac radiation delivery, as this is a major breakthrough in improving the efficacy of radiation therapy for patients,” said Benjamin Movsas, M.D., chairman of Radiation Oncology at the Henry Ford Cancer Institute in Michigan. “At the Henry Ford Cancer Institute, we’re proud to be among the first centers to offer treatment with MRIdian Linac. The ability to see what’s happening inside the body while the patient is undergoing radiation therapy and ensure the radiation continually remains on target is a huge leap forward and will help us to improve patient outcomes.”

“With MRI-guided radiation therapy, we’re able to watch the movement of tumors and organs in the body as radiation is being delivered and adapt the dose of radiation in real-time, to help ensure the maximum dose reaches the tumor and that surrounding healthy tissue is spared,” said Sasa Mutic, Ph.D., director of Radiation Oncology Physics at Washington University School of Medicine. “This technology helps us treat tumors such those in the lung, liver and pancreas where increased precision is important due to nearby organs and other critical structures.”

Source: ViewRay

Scopis ENT Surgical Navigation System Cleared in USA & Canada

Photo: Scopis

Scopis, a company specializing in surgical navigation and medical augmented reality, announced today that it has received 510(K) clearance from the U.S. Food and Drug Administration (FDA) and Health Canada Medical Device License (MDL) for its breakthrough next-generation surgical navigation products for ear, nose and throat (ENT) surgery. To support the market launch, the Company also announced that Karl Ring has joined Scopis as Vice President of Sales in North America.

“Scopis currently provides surgical navigational systems with augmented reality for ENT, craniomaxillofacial, spine and neurosurgery procedures in 50 countries worldwide,” said Bartosz Kosmecki, CEO and Founder of Scopis. “Receiving both FDA 510(K) and MDL clearance enables the immediate commercial launch of our innovative ENT-based products in these significant North American markets.”

Mr. Kosmecki added, “We are excited to welcome Karl, a highly-experienced sales executive in our sector, to lead our commercialization efforts in North America. Operating from our new location in Cambridge, Massachusetts, we are well-prepared to enter these markets.”

Scopis designs surgical navigation systems that use augmented reality (AR) technology, where real-world imaging data from the surgical environment is enhanced by integrating computer-generated images. Scopis’ next-generation Target-Guided Surgery Systems (TGS)*, lead a surgeon along mapped-out pathways directly to anatomical targets using AR-generated images overlaid onto the surgeon’s endoscopic view.

The heart of the Scopis technology is the premium Hybrid Navigation platform that is based on a small and portable unit that supports optical, electromagnetic, and simultaneous hybrid tracking*. It allows surgeons to choose the best-suited technology for variety of surgical procedures across different disciplines. The modularity and versatility of this powerful platform also permits interdisciplinary use.

“With my experience in the US market, specifically in the ENT space, I’m confident that this breakthrough technology in surgical navigation will have a substantial impact on the ENT community and patients. I am looking forward to bringing these products to surgeons performing sinus procedures in both hospital and office-based settings,” said Karl Ring, VP Sales North America of Scopis.

Karl Ring joins Scopis as a seasoned expert in the fields of sales, marketing and business development for medical devices, including those specifically for ears, nose and throat. Most recently, Karl held the position of Director of Market Development, ENT at Smith & Nephew, Inc., where he also provided strategic consulting for transactions dealing with business and sales development. Prior to that, he held similar roles, ranging from Business Development, International, at ENTrigue Surgical to Vice President of Sales and Marketing at Biotronic NeuroNetwork and Regional Sales positions with Medtronic ENT.

Soruce: Scopis GmbH

Oral delivery system could make vaccinations needle-free

Photo: UC Berkeley

Patients could one day self-administer vaccines using a needleless, pill-sized technology that jet-releases a stream of vaccine inside the mouth, according to a proof-of-concept study conducted at UC Berkeley.

The study did not test vaccine delivery in people, but demonstrated that the technology, called MucoJet, is capable of delivering vaccine-sized molecules to immune cells in the mouths of animals. The technology is a step toward improved oral vaccine delivery, which holds the promise of building immunity in the mouth’s buccal region of cells, where many infections enter the body. When patients hold the MucoJet against the inside of their cheek, the device releases a jet stream that directly targets the buccal region. This region is rich in immune cells but underutilized in immunology because of the challenge of efficiently penetrating the thick mucosal layer in this part of the oral cavity with existing technologies, such as the oral spray often used for influenza vaccination.

In laboratory and animal experiments, the research team showed that the MucoJet can deliver a high-pressure stream of liquid and immune system-triggering molecules that penetrate the mucosal layer to stimulate an immune response in the buccal region. The jet is pressurized, but not uncomfortably so, and would remove the sting of needles.

“The jet is similar in pressure to a water pick that dentists use,” said Kiana Aran, who developed the technology while a postdoctoral scholar at Berkeley in the labs of Dorian Liepmann, a professor of mechanical and bioengineering, and Niren Murthy, a professor of bioengineering. Aran is now an assistant professor at the Keck Graduate Institute of Claremont University.

The portable technology, designed to be self-administered, stores vaccines in powder form and could one day enable vaccine delivery to remote locations, but years of further study are needed before the device would be commercially available.

Source: UC Berkeley