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August 21, 2017

Medtronic Receives CE Mark for Attain Stability Heart Lead


Medtronic announced it has received CE (Conformité Européene) Mark for the Attain Stability Quad MRI SureScan left heart lead. Paired with Medtronic quadripolar cardiac resynchronization therapy-defibrillators (CRT-D) and -pacemakers (CRT-P), the Attain Stability Quad lead features novel, active-fixation technology that is designed for precise lead placement and stability. In the United States, the Attain Stability Quad lead is under evaluation in a clinical trial and is not approved for sale.



The company has undertaken a limited European launch, and first commercial implants recently were performed at Haukeland University Hospital, Bergen, Norway.



CRT is a treatment for heart failure in which an implantable device sends low levels of energy through thin wires, called leads, to stimulate the heart muscle and improve the heart's pumping efficiency. The Attain Stability Quad lead, which is approved in CE Marked geographies for 3 Tesla (T) and 1.5T magnetic resonance imaging (MRI) scans, features a side-helix designed to be fixated precisely in veins of various sizes. Four electrodes (quadripolar technology) allow physicians flexibility in finding the optimal location for stimulating the heart.



Medtronic also has initiated a global, prospective, non-randomized, multicenter clinical study to evaluate the safety and effectiveness of the lead in heart failure patients. The study will enroll up to 471 patients across 56 sites in the United States, Canada, Europe, Hong Kong and Malaysia. The primary efficacy endpoint will evaluate the number of patients that have appropriate pacing capture thresholds in at least two programming configurations, and the primary safety endpoint is lead-related complication-free rate at six months. Co-principal investigators are Kevin Jackson, M.D., heart rhythm specialist at Duke Raleigh Hospital, and assistant professor of medicine at Duke University, and George Crossley, III, M.D., associate professor of medicine and electrophysiologist at Vanderbilt Heart and Vascular Institute. Toshimasa Okabe, M.D., recently performed the first implant in the clinical trial at Ross Heart Hospital of The Ohio State University Wexner Medical Center.




See more about the Attain Stability Quad MRI SureScan on Meddevicetracker.



BIOTRONIK Announces US Launch of Edora 8 HF-T QP


BIOTRONIK announced the commercial availability of Edora HF-T QP, an MR conditional quadripolar (QP) cardiac resynchronization therapy pacemaker (CRT-P) with MRI AutoDetect technology.




With a volume of 15 cc, Edora HF-T QP is one of the smallest MR conditional CRT-P available in the US with a longevity of nearly 10 years, reducing the frequency of device replacements for heart failure patients. Edora HF-T QP features MRI AutoDetect, Closed Loop Stimulation (CLS) and BIOTRONIK Home Monitoring with automatic, daily transmission verification. BIOTRONIK Home Monitoring is a cardiac device remote monitoring system designed to improve health outcomes in heart failure patients.




BIOTRONIK’s MRI AutoDetect technology is designed to improve patient safety by minimizing the time the device is in MRI mode and remedying logistical programming challenges for physicians and health systems. Once activated by a clinician, MRI AutoDetect automatically recognizes when a patient enters an MRI field and changes the device programming to MRI mode.




The BIOTRONIK Home Monitoring system includes the Heart Failure Monitor Online, a summary of nine long-term heart failure statistics including thoracic impedance. When combined with daily updates, this allows physicians to continuously monitor and evaluate patients’ heart failure status. Equipped with comprehensive patient monitoring and easily accessible statistical trends, physicians can review individual patient data quicker, leading to early intervention and better outcomes.




See more about the Edora 8 HF-T QP on Meddevicetracker.



August 22, 2017

DexCom Announces Results from DIAMOND Study


Data from the Phase IV DIAMOND Study were published in an abstract titled "Continuous Glucose Monitoring Versus Usual Care in Patients With Type II Diabetes Receiving Multiple Daily Insulin Injections: A Randomized Trial" in the Annals of Internal Medicine on August 22, 2017.




Continuous glucose monitoring (CGM), which studies have shown is beneficial for adults with type I diabetes, has not been well-evaluated in those with type II diabetes receiving insulin. The goal of this study was to determine the effectiveness of CGM in adults with type 2 diabetes receiving multiple daily injections of insulin. In this randomized clinical trial, 158 adults were split into two treatment arms; 79 Patients were treated in Dexcom G4 CGM treatment arm and 79 patients were treated in the usual care Control Arm. The study lasted 24 weeks.




The primary outcome was HbA1c reduction at 24 weeks.




Mean HbA1c levels decreased to 7.7% in the CGM group and 8.0% in the control group at 24 weeks (adjusted difference in mean change, −0.3% [95% CI, −0.5% to 0.0%]; P = 0.022). The groups did not differ meaningfully in CGM-measured hypoglycemia or quality-of-life outcomes. The CGM group averaged 6.7 days (SD, 0.9) of CGM use per week.




  • After 24 weeks participants with Type II diabetes using CGM while on MDI insulin therapy averaged a 0.8 percent A1C reduction compared to baseline (changes in A1C are measured as absolute percent changes; in this case, a reduction from an average baseline A1C of 8.5% to 7.7%)
  • A subset of this group with an A1C of 9.0 percent or higher saw an average 1.4 percent reduction from baseline at week 24
  • The CGM group also decreased time in hyperglycemia and increased time spent in the target range compared to the control group (use of only a standard meter to test glucose)
  • The CGM group increased time in range by 1.3 hours compared to baseline, and 0.6 hours compared to the control group
  • The A1C reductions occurred with minimal changes in insulin dosages or regimen, and nearly no additions of non-insulin diabetes medications




A high percentage of adults who received multiple daily insulin injections for type II diabetes used CGM on a daily or near-daily basis for 24 weeks and had improved glycemic control. Because few insulin-treated patients with type II diabetes currently use CGM, these results support an additional management method that may benefit these patients.




See more about the Dexcom G4 Platinum CGMS on Meddevicetracker.



August 23, 2017

Tandem Diabetes Announces U.S. Launch of the t:lock Connector


Tandem Diabetes announced the launch of the t:lock Connector for its insulin pump cartridges and infusion sets. All of the infusion sets currently offered by the Company will be made available with the new t:lock Connector, produced and supplied by Unomedical a/s, a ConvaTec Group Plc company.




The t:lock Connector was designed to look and feel like the previous Luer-lock connector, while improving the customer experience of filling an infusion set with insulin. The Connector incorporates a smaller inner cavity, which reduces the amount of insulin used in the process and reduces the time required to fill the infusion set tubing.




Unomedical manufactures Tandem’s existing sets as well as many of the most popular private-labeled infusion sets of major insulin pump manufacturers under their respective brand names. The t:lock versions of Tandem’s current infusion sets will be sold under the brand names AutoSoft, VariSoft and TruSteel. Tandem will conduct a gradual rollout of its t:lock Connector to all customers and distributors beginning September 5, 2017 and anticipates fully transitioning by the end of 2017.




No action is required by Tandem customers at this time. Tandem and its authorized distributors will work with customers to provide current Luer-lock versions of infusion sets and cartridges that are compatible with supplies they have on hand before transitioning to the t:lock Connector cartridges and infusion sets (while supplies last). Only t:lock Connector infusion sets will work with the new t:lock Connector cartridges. Infusion sets and cartridges featuring the t:lock Connector will have the same insurance coverage as current supplies.




See more about the t:slim X2 Insulin Pump on Meddevicetracker.




SI-BONE Announces Positive Coverage from Highmark



SI-BONE announced that Highmark, the nation’s 4th largest Blue Cross and Blue Shield-affiliated insurer, has established an exclusive positive coverage policy for MIS SI joint fusion using the iFuse Implant System. Highmark, an independent licensee of the Blue Cross and Blue Shield Association, includes Blue Cross Blue Shield (BCBS) of Pennsylvania, BCBS of Delaware and BCBS of West Virginia.




The policy provides iFuse coverage for more than 4.5 million Blue Cross Blue Shield plan members in Pennsylvania, Delaware and West Virginia effective August 21, 2017.




See more about the iFuse Implant System on Meddevicetracker.



Abbott Announces PMA Approval of the Heartmate 3 LVAD


Abbott announced that it has received U.S. Food and Drug Administration (FDA) approval for its Full MagLev HeartMate 3 Left Ventricular Assist System (also known as an LVAD). The HeartMate 3 system is indicated for providing short-term hemodynamic support (e.g., bridge to transplant or bridge to myocardial recovery) in patients with advanced refractory left ventricular heart failure. The system also provides patients living with their device new benefits that embody the evolution of left ventricular assist device (LVAD) therapy, such as improved blood flow in a pump that uses full magnetic levitation to reduce trauma to blood passing through the system.




Abbott submitted the PMA application in December 2016.




U.S. approval of the HeartMate 3 system was supported by the MOMENTUM 3 clinical study. In that study, patients who received a HeartMate 3 system had a significant improvement in their heart failure status, an 83 percent increase in their walk distance and a 68 percent improvement in quality of life at six months. Patients receiving HeartMate 3 also had an 86 percent survival rate with freedom from disabling stroke and reoperation to replace the pump at six months.




The MOMENTUM 3 study includes more than 1,000 patients with New York Heart Association (NYHA) Class IIIB or IV heart failure. Patients were followed for a short-term endpoint of six months and continue to be followed for a long-term endpoint of two years.




The HeartMate 3 system can pump up to 10 liters of blood per minute and Abbott claims that it is the only commercially-approved continuous flow implantable left ventricular assist system to utilize Full MagLev (fully magnetically-levitated) Flow technology, which allows the device's rotor to be "suspended" by magnetic forces—rather than bearings—with the goal of being able to more gently pass the blood cells through the pump. The magnets keep the rotor in place by calibrating tens of thousands of times per second to ensure it stays suspended and centered within the pump, no matter the speed settings used by a physician. This ensures the pump is performing effectively while continuing to deliver the best patient therapy possible.




The HeartMate 3 system also uses one of the industry's widest pump pathways, designed so the blood cells are not damaged when passing through. The system also relies on a built-in "pulse" programmed to help ensure the blood continues to move through without becoming static, therefore reducing the risk of blood clot formation.




The HeartMate 3 system includes the LVAD pump as well as the rest of the components that are crucial to making the technology work—an external, wearable controller, driveline and battery system that powers the pump. The HeartMate 3 System was CE Mark approved in Europe for both short-term and long-term support in October 2015.




See more about the Heartmate 3 on Meddevicetracker.




August 24, 2017

Propeller Health Announces Expansion of Collaboration with GSK


Propeller Health announced the expansion of its 2015 collaboration with GlaxoSmithKline (GSK), enabling both companies to prepare for and undertake commercial activities using the Propeller clip-on sensor and software platform for use with GSK's ELLIPTA Inhaler. The companies will continue ongoing research and development efforts to collect evidence from the Propeller clip-on sensor and software platform used in conjunction with GSK's respiratory medicines for asthma and COPD.




The announcement follows successful CE marking and US FDA 510(k) class II clearance of the Propeller sensor and software program for the ELLIPTA Inhaler, in late 2016. The clip-on sensor for the ELLIPTA Inhaler automatically records medication use, which the Propeller platform analyzes and presents to patients and physicians through its data-driven digital interfaces, providing an in-depth view into adherence.




See more about the Propeller System on Meddevicetracker.




NxStage Medical Announces Clearance for Home Hemodialysis


NxStage Medical announced that the U.S. Food and Drug Administration (FDA) has cleared its System One for solo home hemodialysis, without a care partner, during waking hours.




Since receiving its first clearance for home hemodialysis from the FDA in 2005 and the first and only home nocturnal hemodialysis clearance in 2014, the NxStage System One has provided over 14 million treatments to thousands of patients in their homes around the world, during the day and at night. However, certain patients have not had access to this therapy option due to the fact that the System One's indication has required that a care partner be present when a patient performs home hemodialysis. This new expanded indication provides both new and existing System One patients, trained to perform solo home hemodialysis, the freedom to dialyze at home without a care partner during waking hours.




NxStage will be working with its customers and partners to implement additional patient training for this new indication later this year and into 2018.




NxStage Medical submitted the 510(k) application in May 2017.




See more about the NxStage System One on Meddevicetracker.





August 25, 2017

Novo Nordisk Announces Approval of Victoza


The U.S. Food and Drug Administration (FDA) has approved a new indication for Victoza (liraglutide) to reduce the risk of major adverse cardiovascular (CV) events in adults with type 2 diabetes and established CV disease.




The FDA's decision is based on the results from the LEADER trial, which demonstrated that Victoza statistically significantly reduced the risk of cardiovascular death, non-fatal heart attack or non-fatal stroke by 13% vs placebo, when added to standard of care, with an absolute risk reduction of 1.9%. The overall risk reduction was derived from a statistically significant 22% reduction in cardiovascular death with Victoza treatment vs placebo, with an absolute risk reduction of 1.3%, and non-significant reductions in non-fatal heart attack and non-fatal stroke.




Victoza is administered via an injection pen that contains 18 mg of a drug solution and will deliver doses of 0.6 mg, 1.2 mg, or 1.8 mg. It uses a thin needle and includes a dose monitor to keep count of remaining injections.




See more about the Victoza Pen on Meddevicetracker. As this product is a drug-device combination product, the full regulatory and clinical history of Victoza can be seen in the Biomedtracker profile.



NIH Announces Data from a Cohort Study on Crouch Gait


Researchers from the National Institute of Health announced data from a cohort study on crouch (or flexed-knee) gait in children with cerebral palsy using a newly developed robotic exoskeleton.




The study followed seven individuals between the ages of 5 and 19 who were diagnosed with crouch gait from cerebral palsy and had Gross Motor Function Classification System levels I-II, meaning each could walk at least 30 feet without use of a walking aid.




Walking with the exoskeleton was well-tolerated with all participants able to walk independently without a mobility aids or therapist assistance with six doing so in the first practice session. Improvements in knee extension were observed in six participants with gains (8-37°) similar to or greater than average improvements reported from invasive surgical interventions. Importantly, the gains in knee extension occurred without a reduction in knee extensor muscle activity, indicating that these participants worked with the exoskeleton rather than offloading the task of straightening the leg during walking to the robot.




The exoskeleton that the NIH has developed is specifically designed to treat crouch (or flexed-knee) gait in children with cerebral palsy by providing powered knee extension assistance at key points during the walking cycle. The exoskeleton consists of two motorized braces that attach to the legs and don’t extend up to the rest of the body. The devices help push the legs during certain points of each step, constantly monitoring at which point in the step the child is in and reacting accordingly.




See more about the Robotic Exoskeleton on Meddevicetracker.

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