Meddevicetracker weekly round up

January 8, 2018

Medicare Part D Plans May Now Cover OmniPod

Insulet announced that the Centers for Medicare and Medicaid Services (CMS) has issued guidance clarifying that Medicare Part D Plan Sponsors may provide coverage for products such as the Omnipod System under the Medicare Part D (prescription drug) program. Under Part D drug benefit, the physician writes a prescription, the patient goes to the pharmacy, and is able to pick up their insulin as well as their Omnipod System to deliver insulin into the body.

The CMS guidance empowers Insulet to begin working with Medicare Part D carriers to ensure beneficiaries living with diabetes have access to the Omnipod System. Securing Medicare Part D coverage also provides Insulet with a direct pathway to gain Medicaid coverage at the state level, as many state-run Medicaid programs follow CMS prescription drug guidance to determine coverage. This allows access for lower-income individuals and families on Medicaid for whom Omnipod is currently not an option. The Company estimates that obtaining Medicare and Medicaid coverage extends access to Insulet's Omnipod System to approximately 450,000 additional individuals with Type I diabetes in the United States.

See more about the OmniPod Insulin Management System on Meddevicetracker.

Tandem Diabetes Care Reports Successful Completion of First Pilot Study Using t:slim X2 Insulin Pump with TypeZero Hybrid Closed Loop Technology and Dexcom G6 Integration

Tandem Diabetes Care reported the successful completion of the first pilot study using a hybrid closed loop system featuring its t:slim X2 Insulin Pump with embedded algorithms from TypeZero Technologies and integration with Dexcom G6 Continuous Glucose Monitoring (CGM). This pilot study was the first of three in the National Institute of Health (NIH)-funded International Diabetes Closed Loop (IDCL) Trial using the t:slim X2 Pump running the algorithm directly on the pump. The second study is now moving forward with enrollment at seven clinical sites and is anticipated to begin in the first quarter of 2018. The IDCL Trial is expected to conclude with a pivotal study in 2018, and Tandem plans to use this data in a PMA submission to the U.S. Food and Drug Administration (FDA). Following the FDA approval, the Company is looking to launch the product in the first half of 2019.

The hybrid closed loop system predicts high and low blood sugar levels and adjusts insulin delivery accordingly throughout the day, while still allowing the user to manually bolus for meals. In addition to basal insulin adjustments, the system also automates correction boluses. The hybrid closed loop software developed by TypeZero includes a series of algorithms developed from initial research conducted at the University of Virginia.

The IDCL Trial started in late 2016 and is expected to include up to 360 adults with Type I Diabetes across all of its studies. Earlier phases of the IDCL, iDCL Main trial and iDCL Research Site Training Protocol trial used a Tandem insulin pump and Dexcom G5 sensor as part of a blood glucose control system that combined these devices with a smartphone running TypeZero’s inControl closed loop algorithms. The latest series of studies, now using the fully-integrated system, began with the supervised 36 to 48-hour pilot study in 5 subjects conducted at the University of Virginia. The next study, scheduled to take place in early 2018, will be a two-week, at-home study with enrollment at seven centers across the United States. A pivotal trial is planned to take place at these same centers following successful completion and review of the two-week study.

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

Endotronix Announces Successful First-In-Human Implantation of the Cordella Pulmonary Artery Pressure Sensor and Initiation of the SIRONA Clinical Trial

Endotronix announced the successful first-in-human implantation of the Cordella Pulmonary Artery (PA) Pressure Sensor and initiation of the SIRONA First-in-Human (FIH) clinical trial. Cardiologists Prof. Dr. Wilfried Mullens of Ziekenhuis Oost-Limburg and University Hasselt and Dr. Matthias Dupont of Ziekenhuis Oost-Limburg, both co-investigators of the SIRONA trial, performed the first implant at the Hospital Ziekenhuis Oost-Limburg in Genk, Belgium.

The SIRONA FIH trial is designed to evaluate the safety and performance of the Cordella PA Pressure Sensor in the treatment of advanced heart failure patients who remain unstable despite standard of care medical management. The wireless Cordella PA Pressure Sensor, the implantable component of the Cordella Heart Failure (HF) System, provides PA pressure data readings that clinicians interpret to guide therapy and provide proactive HF management. The Cordella HF System is a comprehensive disease management system that enables on-going therapeutic interventions to improve patient quality of life and decrease heart failure readmissions. The system collects and securely transmits biometric and relevant clinical data to the heart failure clinician, creating accurate snapshots of the patient’s health status over time. The myCordella Patient Management Portal is designed to streamline patient management for the clinician and support the delivery of complex chronic disease management.

SIRONA Study Design

The SIRONA trial will enroll up to 10 patients at two European sites. The primary safety endpoint is freedom from adverse events related to use of the system through 30-days post sensor implantation. Accuracy of the Cordella PA Pressure Sensor readings as compared to a fluid-filled PA pressure measurement taken by right heart catheterization (RHC) at 90-days is the primary efficacy endpoint.

See more about the Cordella Heart Failure System on Meddevicetracker.

January 9, 2018

Biocartis and Amgen Sign New Companion Diagnostic Agreement for Novel Oncology Compound

Biocartis Group announced the signing of a new companion diagnostic (CDx) development agreement with Amgen aimed at the development of Idylla CDx biomarker tests for a novel oncology compound to be used in the treatment of certain solid tumors.

This is the second CDx agreement that Biocartis has signed with Amgen. The first CDx agreement between both companies was announced on December 4, 2017 and aims to register the Idylla KRAS Mutation Test and the Idylla NRAS-BRAF Mutation Test with the US Food and Drug Administration (FDA) as a CDx test for Amgen’s drug Vectibix (panitumumab).

See more about the Idylla CDx on Meddevicetracker.

Ozempic Approved in Canada for the Treatment of Adults with Type 2 Diabetes

Novo Nordisk announced that Health Canada has approved Ozempic (semaglutide injection) as an adjunct to diet and exercise to improve glycemic control in adults with type II diabetes mellitus, when metformin is not tolerated or contraindicated. Ozempic, a once-weekly glucagon-like peptide 1 (GLP-1) receptor agonist, can also be used together with other antidiabetic drugs, when diet and exercise do not achieve adequate glycemic control.

Ozempic was studied in the SUSTAIN clinical trial program, which involved more than 8,000 adults with type II diabetes. In the SUSTAIN program, Ozempic was studied in combination with oral-antidiabetic agents and basal insulin.

In pivotal trials, Ozempic demonstrated statistically significant and sustained blood glucose control compared to sitagliptin, exenatide extended-release, once-daily insulin glargine U100 and placebo. These trials also evaluated the effect of Ozempic on weight loss compared with such treatments.

Across the SUSTAIN clinical trial program, Ozempic had a safe and well-tolerated profile. The most frequently reported adverse reactions in clinical trials were gastrointestinal disorders, including nausea, diarrhea and vomiting. In general, these reactions were mild or moderate in severity.

Ozempic will be available in a prefilled pen, based on the latest generation of Novo Nordisk prefilled devices.

See more about the Ozempic Pre-Filled Pen on Meddevicetracker.com

CardioFocus Announces Expanded Partnership with Japan Lifeline

CardioFocus announced that it has entered into an expanded partnership with Japan Lifeline Co (JLL). The expanded partnership solidifies the commercial strategy for bringing the HeartLight Endoscopic Ablation System to the Japanese market. 

To support Japanese approval, CardioFocus originally established a distribution partnership with JLL in 2015. Since receiving approval from the Japanese Ministry of Health, Labour and Welfare in July 2017, initial commercial cases have been completed successfully at four hospitals. The companies expect a full commercial launch of the HeartLight System to begin in 2018 after national reimbursement is in place. 

Under the expanded agreement, CardioFocus and JLL will increase the scope of their Japan commercialization efforts and pursue commercialization of the HeartLight System in other Asia Pacific markets. JLL is also making a substantial financial investment in CardioFocus that will be used to accelerate the market expansion of HeartLight globally and support development of the company's third-generation product, the HeartLight X3 System, which will begin clinical evaluation in Europe during 2018 with prospects of a Japan launch in the future. 

The HeartLight System is a visually guided laser balloon technology for controlled and consistent pulmonary vein isolation (PVI) treatment of atrial fibrillation (AF). Its direct visualization, titratable laser energy, and universal balloon design make it a new standard for PVI procedures. It provides an effective and safe treatment option for patients whose heart arrhythmias are insufficiently controlled with medication. 

See more about the HeartLight Endoscopic Ablation System on Meddevicetracker.




Medtronic Enrolls First Patient in Pain Study to Assess Optimized Spinal Cord Stimulation Programming

Medtronic announced the first patient enrolled in the Vectors Post Market Clinical Study. The study will follow patients with chronic intractable pain who are undergoing spinal cord stimulation (SCS) treatment managed with the Evolve workflow, which standardizes guidance that balances high-dose (HD) and low-dose (LD) therapy settings to help physicians optimize treatment. Evolve runs on Medtronic SCS systems including Intellis which recently received U.S. Food and Drug Administration approval and CE Mark approval. The first patient was enrolled by The Center for Interventional Pain & Spine in Wilmington, Delaware.

Lead investigators for the trial include John Hathaway, M.D. (Northwest Pain Care) and Michael Fishman, M.D. (The Center for Interventional Pain & Spine).

The Vectors study is a prospective, multi-center, post-marketing study that will enroll up to 175 patients with chronic intractable pain of the low back and legs at up to 25 sites in the U.S. The study will assess SCS's long-term efficacy and impact on quality of life and was designed to provide evidence for the Evolve workflow by evaluating the effectiveness and potential patient benefits of having access to both HD and LD stimulation modalities. Patients will be followed for 12 months post implant.

The Intellis platform offers several patient benefits. Using Medtronic's Overdrive battery technology, the Intellis platform can be fully recharged in approximately one hour, addressing a common patient complaint about the burden of recharging their implant. Physicians also get new tools, including Snapshot, a software platform that tracks activity, body positions and therapy usage. This provides physicians with objective insights about patient outcomes, like mobility and progress.

See more about Intellis on Meddevicetracker.

January 10, 2018

Aesculap and Christoph Miethke Found Joint Venture

Aesculap, a subsidiary of B. Braun Melsungen AG, together with Christoph Miethke announced the formation of the joint venture B. Braun Miethke GmbH & Co. KG. The newly established B. Braun Miethke GmbH, based in Potsdam, is devoted to developing implants for targeted drug delivery. The Company is expected to bring its first product in this field to the market within the next few years.

The drug delivery implant will transport pharmaceuticals directly to the targeted location in the patient’s body. This allows for a significant dose reduction and therefore reduces undesirable side effects for the patients.

See more about B. Braun and the new Drug Delivery Implant on Meddevictracker.

Check-Cap Receives CE Mark Approval for C-Scan

Check-Cap announced it has received CE Mark approval for the C-Scan system.

The C-Scan system offers an alternative to current colon cancer screening methods that require laxative preparation and invasive endoscopic procedures. This novel platform consists of a fully autonomous system that utilizes an ingestible, ultra-low dose X-ray capsule combined with a wireless tracking system, enabling generation of structural information on the lumen of the colon. This information is used to create 2D and 3D maps of the colon, allowing physicians to identify pre-cancerous polyps and other abnormalities. C-Scan is designed to improve the patient experience and increase the number of adults screened by eliminating procedural requirements frequently cited as barriers to adherence to screening guidelines such as bowel preparation, fasting, and sedation.

See more about the P1 Capsule System on Meddevicetracker.

UnitedHealthcare and Dexcom Announce Glucose Management Pilot Program

UnitedHealthcare and DexCom announced an individualized glucose management pilot program driven by wearable technology to help people with Type II diabetes manage their condition in real time. The program is being showcased at the annual technology convention, the Consumer Electronics Show (CES), in Las Vegas.

Eligible UnitedHealthcare Medicare Advantage plan participants can use the Dexcom Mobile Continuous Glucose Monitoring (CGM) System to track their blood glucose levels 24/7, enabling them to understand how their behaviors affect their glucose so they can take appropriate actions. Participants also receive personalized diabetes coaching and an activity tracker to help them understand and act upon the data gathered by the CGM device. Together, these tools empower people with Type II diabetes to manage glucose levels and can result in increased glucose control, reductions in medications and improved confidence in managing their diabetes.

The program is part of UnitedHealthcare's focus on integrating human support with data from real-time sources, such as digital health technology, and historical sources, like claims data, to help improve and personalize how people navigate the health care system.

DexCom and UnitedHealth announced the partnership in November 2017.

See more about the Dexcom G4 Platinum CGMS on Meddevicetracker.

January 11, 2018

Cordis and Medinol Announce First U.S. Commerical Implants of EluNIR Drug-Eluting Stent

Cordis and Medinol announced that the first commercial cases using the EluNIR drug-eluting stent (DES) in the United States were performed at New York-Presbyterian Hospital/Columbia University Medical Center in New York City and the Piedmont Heart Institute in Atlanta.

The EluNIR stent was approved in November 2017 for the treatment of patients with narrowing or blockages to their coronary arteries and is now being distributed to cath labs in the U.S. by Cordis. The EluNIR stent system is designed to help clinicians deliver this new DES in highly complex anatomy and disease and offers a novel metallic spring tip and one of the narrowest strut widths of any stent on the U.S. market.

Cardinal Health and Medinol entered into a long-term distribution agreement that gives Cordis, Cardinal Health’s interventional vascular business, the rights to sell Medinol’s coronary stent portfolio, which now includes the EluNIR DES and NIRxcell, a cobalt-chromium bare metal stent (BMS), in the U.S.

See more about the EluNIR Drug Eluting Coronary Stent System on Meddevicetracker.

LivaNova Initiates BELIEVE Aortic Heart Valve Study in the U.S. and Canada

LivaNova announced that the first patient has been enrolled in the Behavior of Valve Leaflets and the Incidence of Reduced Mobility Post-Surgical Aortic Valve Implant Study (“BELIEVE”). This study is a post-market, prospective, interventional, multi-center trial designed to report the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a commercially approved LivaNova bioprosthetic aortic heart valve.

The BELIEVE study is expected to enroll approximately 230 patients at 15 sites from the U.S. and Canada to ascertain whether valve leaflets are fully operational following surgery. Four-dimensional, volume-rendered CT scans will be obtained from patients at a minimum of 30 days after they discontinue anticoagulation or dual antiplatelet therapy. There will be one year of follow-up for all patients.

See more about the Crown PRT, Freedom SOLO Stentless Heart Valve, and the Perceval S Valve on Meddevicetracker.

January 12, 2018

Repatha SC Injection 420mg Auto Mini Doser Launched in Japan

Amgen and Astellas Pharma announced the launch of Repatha SC Injection 420 mg Auto Mini Doser (AMD), an additional dosage formulation to Repatha SC Injection 140 mg Syringe and Pen. Repatha is for the treatment of patients with familial hypercholesterolemia or hypercholesterolemia who have high risk of cardiovascular events and do not adequately respond to HMG-CoA reductase inhibitors (statins).

The new Repatha SC Injection 420 mg AMD is a new dosage form consisting of a compact, palm-sized device with prefilled cartridge and a dedicated injection system. While the conventional syringes and pens required three subcutaneous injections of 140 mg to administer 420 mg, Repatha SC Injection 420 AMD delivers a single dose in 9 minutes with a hands-free delivery system, allowing the patient to walk, stretch their arms, bend at the waist, or do other moderate everyday activities. Another characteristic of the product design is the needle which stays hidden during administration.

Repatha is approved in more than 50 countries, including the U.S., Japan, Canada, and in all 28 countries that are members of the EU. Applications in other countries are pending.

See more about the Repatha Pushtronex System on Meddevicetracker.

Myriad Receives FDA Approval of BRACAnalysis CDx as Companion Diagnostic for Lynparza in Patients with Metastatic Breast Cancer

 Myriad Genetics announced that the U.S. Food and Drug Administration (FDA) approved BRACAnalysis CDx for use as a companion diagnostic by healthcare professionals to identify patients with HER2-negative metastatic breast cancer who have a germline BRCA mutation and are candidates for treatment with the PARP inhibitor Lynparza (olaparib), marketed by AstraZeneca and Merck, known as MSD outside of the U.S. and Canada.  BRACAnalysis CDx is the first and only FDA-approved test for use in this indication.

The collaboration with AstraZeneca to develop a novel companion diagnostic test to identify candidates for treatment with olaparib began in 2007.  The new metastatic breast cancer indication is the second FDA approval of BRACAnalysis CDx for use in conjunction with Lynparza.  In Dec. 2014, Myriad received FDA approval for BRACAnalysis CDx to help identify patients with advanced ovarian cancer who are eligible for fourth-line treatment with olaparib.  BRACAnalysis CDx is Myriad's first FDA-approved companion diagnostic and was the first-ever laboratory developed test approved by the FDA.

See more about the BRACAnalysis Companion Diagnostic on Meddevicetracker.