November 20, 2017
LivaNova to Sell Cardiac Rhythm Business to Microport
LivaNova and MicroPort Scientific announced that the companies have entered into a binding Letter of Intent (“LOI”) for the sale of LivaNova’s Cardiac Rhythm Management (“CRM”) Business Franchise to MicroPort for $190 million in cash.
The CRM Business Franchise develops, manufactures and markets products for the diagnosis, treatment and management of heart rhythm disorders and heart failures. CRM products include high-voltage defibrillators, cardiac resynchronization therapy devices and low-voltage pacemakers. The CRM Business Franchise generated approximately $249 million in net sales in fiscal year 2016 and has approximately 900 employees with operations chiefly in Clamart, France; Saluggia, Italy; and Santo Domingo, Dominican Republic.
LivaNova and MicroPort expect to enter into the definitive acquisition agreement contemplated by the LOI following completion of the notification and consultation process with CRM’s employee works councils as required by local laws. Completion of the transaction is subject to entry into the definitive acquisition agreement, receipt of relevant regulatory approvals, including fulfilling the requirements of the Hong Kong Stock Exchange’s Major Transaction requirements, and other customary closing conditions. The companies expect the transaction to close in the second quarter of 2018.
LivaNova anticipates it will recognize a material impairment primarily related to the intangible assets of its CRM Business Franchise during the fourth quarter of 2017 as a result of the commitment to undertake the proposed transaction. Beginning in the fourth quarter of 2017, LivaNova will present its results from continuing operations on a pro forma basis with the CRM Business Franchise presented as a discontinued operation. As a result, the Company expects full-year 2017 net sales from continuing operations will decrease by approximately 20 percent, adjusted operating margin from continuing operations will increase by approximately 200-300 basis points, and adjusted earnings per share from continuing operations will decrease by 5 to 10 percent, compared to previous guidance provided on November 2, 2017 at the Company’s third quarter earnings call. Additional financial details will be provided during the Company’s fourth quarter and full-year 2017 earnings call.
As closing of the proposed transaction will likely take place in second quarter 2018, MicroPort expects that the proposed transaction will have no impact to the company’s 2017 net profit. The proposed transaction will constitute a Major Transaction of MicroPort under the Listing Rules of the Hong Kong Stock Exchange. Accordingly, MicroPort has issued a Transaction Announcement with the HKSE contemporaneous with this press release and will issue to its shareholders a Transaction Circular with more detailed financial information of the proposed transaction by end of Q1 2018. In addition, MicroPort will provide additional financial details of the transaction during its 2017 earnings call anticipated to be held in April 2018.
See more about LivaNova and MicroPort on Meddevicetracker.
Medtronic Launches Azure Pacemakers with BlueSync
Medtronic announced that U.S. Food and Drug Administration (FDA) has granted approval and U.S. commercial launch for its portfolio of Azure pacemakers with BlueSync technology. Available in both single chamber and dual chamber models, the Azure XT MRI and Azure S MRI pacemakers offer improved longevity, estimated at 13.7 years (dual chamber) or 27 percent longer than its predecessor, so patients likely need fewer device replacements. The new pacemakers also allow patients to have MRI (magnetic resonance imaging) scans in either 1.5 or 3 Tesla (T) machines.
Azure pacemakers feature Medtronic-exclusive BlueSync technology, which enables automatic, secure wireless remote monitoring via the Medtronic CareLink Network, providing timely alerts of clinically relevant patient events that can be reviewed by a clinician at any time. Security controls implemented and validated on BlueSync enabled devices include access restrictions to protect integrity of device functionality and end-to-end encryption to protect patient data.
The Azure XT pacemaker features the Medtronic Reactive ATP (atrial-based antitachycardia pacing) algorithm, which was shown in the MINERVA Trial and real-world studies to slow the progression of atrial fibrillation (AF) in patients with implanted cardiac devices. Common among patients with cardiac devices, AF impairs quality of life and increases the risk of hospitalization, stroke and death.
The approval for the Azure Pacemaker was received in October 2017.
See more about the Azure Pacemaker on Meddevicetracker.
November 21, 2017
MiMedx Receives Positive Coverage for EpiFix
MiMedx Group announced that with the publication of the Venous Leg Ulcer (VLU) study earlier this quarter, one of the nation's largest not-for-profit health plans serving more than 3 million people recently decided to add EpiFix coverage for Diabetic Foot Ulcers (DFUs), VLUs and burns. the Company also added another state Medicaid with nearly 2 million lives adding EpiFix coverage for DFUs, VLUs and burns. The Company expect many more health plans to follow suit with this type of decision in the future.
Over the years, the Centers for Medicare and Medicaid Services (CMS), through its sub-committee, the Healthcare Common Procedure Coding System (HCPCS) Committee, has assigned Q Codes for numerous products. These Q codes are assigned based on the Committee's review and are maintained by the HCPCS national panel, composed of representatives from Blue Cross/Blue Shield Association, the Health Insurance Association of America and CMS. Once assigned, payers typically then determine whether to reimburse those Q Codes. The payers further develop coding decisions based on the product's efficacy. Since MiMedx's EpiFix was introduced to the market in 2011, this is the process that payers have followed regarding EpiFix payment policy.
MiMedx also provided a reimbursement update in light of the recently issued Food and Drug Administration (FDA) Final and Draft Guidance documents related to human tissue titled, "Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use" (the "HCT/P Guidance"). The company believed that with the issuance of the final HCT/P Guidance document issued by the FDA, the payer coverage for EpiFix will further improve.
See more about EpiFix on Meddevicetracker.
Life Spine Announces Alpha Launch of SIMPACT
Life Spine announced the alpha launch of the SIMPACT TRI-FIN Sacroiliac Joint Fixation Screw System. The SIMPACT TRI-FIN system was designed with an anti-rotational sleeve to inhibit component back out, and a screw thread design which affords the surgeon the ability to compress and stabilize the SI joint.
SIMPACT TRI-FIN also continues the use of Life Spine’s OSSEO-LOC technology. OSSEO-LOC is a proprietary surface treatment that creates a unique osteophylic surface architecture for potential bone on-growth. The unique surface architecture promotes mineralization of implant, while negating potential challenges associated with surface treated implants.
See more about the SIMPACT Sacroiliac Joint Compression Screw System on Meddevicetracker.
November 22, 2017
Admedus Receives Regulatory Approval in India
Admedus announced that it has received regulatory approval to launch the company’s flagship CardioCel product in the Republic of India, with Syncronei Medical appointed as the exclusive commercial partner managing all sales, marketing, and distribution.
This approval allows, effective immediately, the commercial sale of CardioCel in one of the world’s most important and dynamic medical markets. The overall Indian healthcare segment is $158 billion and growing rapidly. In a country with approximately 50 million cardiac patients and 28 million births per year, 1 in 1000 or 280,000 babies are being born annually in India with a Congenital Heart Defect (CHD).
Admedus’ agreement with Syncronei Medical followed a comprehensive due diligence process to ensure CardioCel is effectively launched and properly positioned in this major emerging market. Syncronei Medical was awarded the distribution partnership based on their credibility and experience in the Indian regenerative technology and surgical sectors, coupled with an unparalleled ability to introduce CardioCel to India’s lucrative public and private medical tourism market segments which continue to grow impressively.
The Company is currently in the final stages for CardioCel 3D's India pre-market assessment.
See more about the CardioCel on Meddevicetracker.
FDA Closes Warning Letter for Repro Med Systems
Repro Med Systems announced that U.S. Food and Drug Administration has officially notified the Company that the Warning Letter issued in February 26, 2016 has been closed.
The letter was cleared as a result of a comprehensive “Integrated Catch-Up Freedom Syringe Driver System” that was cleared in August 2017. The driver system not only confirmed the science behind the RMS technology but also the general and specific uses for subcutaneous (SQ) medications such as immunoglobulins and intravenous (IV) medications including antibiotics.
See more about the FREEDOM 60 Syringe Infusion System on Meddevicetracker.
November 24, 2017
MicroPort Receives Regulatory Approval in Argentina
MicroPort Scientific announced that the FOXTROT NC PTCA Balloon Catheter, developed in-house by Shanghai MicroPort Medical, recently received regulatory approval from the ANMAT, Argentina's National Administration of Drugs, Foods and Medical Devices. Previously, the product had received CE mark and gained approvals from the US Food and Drug Administration, China Food and Drug Administration, Japan's Ministry of Health, Labour and Welfare, as well as regulatory authorities in the Philippines, Thailand, Brazil, Mexico.
FOXTROT NC PTCA Balloon Catheter is a rapid exchange percutaneous transluminal coronary angioplasty catheter. It is indicated for balloon angioplasty or assisting with balloon expandable stents implantation in pre-dilation as well as post-dilation. The design is an integrated shaft system with a non-compliant balloon near the distal tip. The balloon is designed to provide an inflatable segment of rated diameter and length at recommended pressures. Two radiopaque markers aid in positioning the balloon catheter under fluoroscopy during the procedure. The device features high rated burst pressure, low compliance, and excellent pushability, trackability and crossability.
See more about the FOXTROT NC PTCA Balloon Catheter on Meddevicetracker.
November 27, 2017
Neurotech Signs Design Agreement with eemagine
Neurotech announced it has entered into an agreement with eemagine Medical Imaging Solutions (eemagine) to deliver design enhancements to the Company’s Mente Autism headband. Eemagine is a member of the Neuromotion Group (Neuromotion), the holding company for a range of businesses which develop, sell and service equipment and services for the study and treatment of human brain function in clinical and research applications. Eemagine is the contract manufacturing arm of Neuromotion and is responsible for the development, production and support for OEM development projects for third parties and customers worldwide, including several established brands in the neurology industry.
Under the design agreement with Neurotech, eemagine will look to deliver a number of design enhancements to Mente Autism, including investigating the feasibility of incorporating proprietary research grade waveguard touch electrodes within the headband, as well as designing the headband to suit varying age ranges of children from 3 to 12 years old, so that the headband can “grow” with the child.
See more about Mente Autism on Meddevicetracker.
New Data Featuring PREVENA Published in Scientific Journal
Acelity announced that the new independent data recently published in the Journal of Arthroplasty, entitled "Closed Incision Negative Pressure Therapy Effects on Postoperative Infection and Surgical Site Complication After Total Hip and Knee Arthroplasty," further demonstrates the body of expanding clinical evidence that closed incision negative pressure therapy (ciNPT) with the PREVENA Incision Management System reduces post-surgical wound complication potential. Results of a recent trial of nearly 600 patients undergoing total joint replacement illustrated the benefits of the PREVENA Incision Management System in reducing several surgical site complications. Patients in the study treated with PREVENA Therapy had statistically significant lower rates of overall infection, and were four times less likely to experience a surgical site complication.
A single center, open-label study with a prospective cohort of 192 patients undergoing primary TKA or THA treated with ciNPT of clean surgical wounds was conducted. 192 incisions treated with the PREVENA Incision Management System were compared with a historical control group of 400 patients that had incisions treated with traditional gauze dressing.
The primary endpoint was hospital readmission after the surgery.
Results demonstrate that, with the PREVENA Incision Management System, patients presented:
- Significantly decreased overall rates of infection (including superficial wound infection) (3.5% vs 1.0%, p=0.04)
- Lower overall complication rate (1.5% vs 5.5%, p=0.02)
- Four times less likelihood of experiencing a surgical site complication compared with control (p=0.0277, odds ratio 4.251, 95% confidence interval 1.172-15.414)
- Lower pain score at 24 hours post op (p<.0001)
ciNPT for total knee arthroplasty and total hip arthroplasty in a comprehensive patient population reduced overall incidence of complication, but did not significantly impact the rate of deep infection. Further research to determine clinical and economic advantages of routine use of ciNPT in total joint arthroplasty is warranted.
See more about the PREVENA Incision Management System on Meddevicetracker.
November 28, 2017
Ascensia and Health2Sync Announce Collaboration
Ascensia Diabetes Care and Health2Sync announced a collaboration that aims to improve diabetes care by bringing an integrated digital management solution to patients in Asia. As part of this collaboration, the companies will create a combined offering for people with diabetes that comprises of the CONTOUR PLUS or CONTOUR TS blood glucose monitoring systems from Ascensia, the Health2Sync app and a loyalty program for users, known as the Ascensia Customer Care Program.
Once the combined offering is launched, when people with diabetes purchase the CONTOUR PLUS or CONTOUR TS systems, they will be able to join the Ascensia Customer Care Program after registering for an account in the Health2Sync mobile app. Membership benefits include discount coupons for test strips, promotions and educational materials about diabetes. By using the Health2Sync app, people with diabetes will be able to log their blood glucose readings, track their blood glucose values, and make decisions related to diabetes management based on the analyses provided. A Bluetooth wireless technology enabled dongle from Health2Sync is also available. This dongle connects to the meter and allows data to be directly downloaded from the meter to the app.
Under the terms of the agreement, the bundled package will initially be made available in Hong Kong, Malaysia, Singapore and Taiwan, with potential for additional countries to be added. Health2Sync and Ascensia are also exploring innovative approaches to delivering the combined solution via health insurance providers for people with diabetes.
The Health2Sync diabetes management mobile app and patient management platform are designed to make blood glucose tracking and management more meaningful. The app enables people with diabetes to easily log blood glucose, blood pressure, weight and daily activities to allow them to have a better understanding of their health. The app helps users interpret data they logged and provides customized feedback and reminders that assist users to improve diabetes control. The app also allows people with diabetes to invite friends and family members as partners in the app to support them in managing diabetes together. For healthcare providers, Health2Sync's web-based patient management platform enables more efficient tracking of patients and care provider follow-up.
See more about Panasonic Healthcare and the Health2Sync App on Meddevicetracker.
Boston Scientific Delays Commercialization of the LOTUS Edge
Boston Scientific announced a delay to previously communicated timelines for commercialization of the LOTUS Edge Aortic Valve System in Europe and the U.S.
After initiating a voluntary recall for the LOTUS and LOTUS Edge Aortic Valve Systems earlier this year, Boston Scientific implemented manufacturing process and design specification changes to the LOTUS Edge delivery system with the intent of re-introducing the product in Europe by the first quarter of 2018 and filing the final Pre-Market Approval (PMA) module with the U.S. Food and Drug Administration by January 2018.
The company now expects to provide an update on the status of the LOTUS Edge Valve during its fourth quarter 2017 earnings conference call on February 1, 2018, as it continues to focus on manufacturing and regulatory milestones to support the long-term success of the Lotus platform. Boston Scientific will continue to work closely with the U.S. and European regulatory bodies to share pertinent updates about these delays and impact to submission timing.
See more about the LOTUS Valve on Meddevicetracker.
November 29, 2017
EchoPulse Data Presented at RSNA 2017
Data from the HIFU IDE Feasibility Study using the EchoPulse device were presented during a scientific session in a presentation titled "Ultrasound Guided High Intensity Focused Ultrasound Ablation of Breast Fibroadenoma: A Pilot Study" at the Radiological Society of North America (RSNA) Annual Meeting on November 29, 2017 in Chicago, IL.
Data summarized in this event is solely based on data contained in the abstract from the RSNA abstract website. Sagient was unable to obtain updated data, if any, from the actual presentation at the RSNA conference.
Data from this study were last seen in April 2017.
This study evaluates the safety, feasibility, and efficacy of Ultrasound guided High Intensity Focused Ultrasound (USgHIFU) ablation for treatment of fibroadenomas. USgHIFU provides noninvasive thermal ablation of the fibroadenoma with real-time US guidance during treatment. Twenty women with a palpable breast fibroadenoma were enrolled in a single arm IRB and FDA approved clinical trial. Histologic confirmation of fibroadenoma on core needle biopsy was required. Patients underwent treatment utilizing the Echopulse device. All tumors had a minimum diameter > 1 cm with volume between 0.3 cc and 10 cc. Volume calculation formula = length (mm) x width (mm) x height (mm) x π / (6 x 1000) in cc. During treatment, multiple sonications were delivered within the mass to achieve coagulative necrosis. Optimal energy delivered per sonication was established by determining the minimal setting found to produce a hyperechoic mark observed on real-time B-mode image. Energy settings were also influenced by patient tolerance. Change in tumor size, toxicity, cosmesis, and patient experience were obtained immediately after treatment and at 3, 6, and 12 months.
Twenty patients successfully completed therapy. Mean patient age was 35.2. Mean power/sonication = 38.3 watts. Mean number of sonications = 34.3. Pre-treatment mean tumor volume was 1.8cc (SD 1.23, Range 0.57 - 5.7). Mean reduction in volume of the fibroadenoma at 12 months was -1.12 cc (65%), SD -0.61 cc (22%), Range -2.22 to -0.31 cc (98 to 25%), p-value < 0.0001. No skin burns, damage to adjacent structures, or other major toxicities were observed. On clinical exam, mass was no longer palpable in 80% of patients at 12 months. Patient satisfaction was 4.4 on a scale of 1-5 (5 = most satisfied).
All adverse events (AE) were grade 1 or 2. Mild pain was the most common AE.
USgHIFU ablation is a safe, feasible and efficacious treatment option for breast fibroadenoma. The results are limited by the small size of the study.
See more about the EchoPulse Echotherapy Device on Meddevicetracker.
electroCore Files for Expanded Label of gammaCore
electroCore announced that it has filed for a 510(k) label expansion of gammaCore for the acute treatment of migraines.
The company received De Novo Approval in April 2017 of the gammaCore for the acute treatment of pain associated with episodic cluster headache in adult patients. electroCore noted that the company is continuing to partner with KOLs and other research organizations to study the use of the company’s non-invasive, vagus nerve stimulation (nVNS) therapy in several other potential indications.
See more about gammaCore on Meddevicetracker.
November 30, 2017
Cordis and Medinol Announce FDA Approval of EluNIR
Cordis, a Cardinal Health company, and Medinol announced United States Food and Drug Administration (FDA) approval of the EluNIR drug-eluting stent (DES) for the treatment of patients with narrowing or blockages to their coronary arteries. The EluNIR stent system is designed with a novel metallic spring tip and the one of the narrowest strut widths of any stent on the U.S. market to help clinicians deliver this new DES in highly complex anatomy and disease.
The EluNIR DES demonstrated positive efficacy and safety results in two randomized clinical trials, including BIONICS, a global pivotal study of 1,919 patients from 76 sites in eight countries. In BIONICS, the EluNIR stent demonstrated a 5.4 percent Target Lesion Failure (TLF), one of the lowest reported TLF in a contemporary U.S. pivotal study, and a zero percent rate of late stent thrombosis at 12 months. Medinol recently obtained CE-mark for the EluNIR stent, and it is currently being used by physicians in Europe.
Cardinal Health’s long-term distribution agreement with Medinol enables Cordis, Cardinal Health’s interventional vascular business, 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 BioNIR Drug-Eluting Coronary Stent System on Meddevicetracker.
FoundationOne CDx Receives FDA Approval
The U.S. Food and Drug Administration (FDA) approved the FoundationOne CDx (F1CDx), the first breakthrough-designated, next generation sequencing (NGS)-based in vitro diagnostic (IVD) test that can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type. The Centers for Medicare & Medicaid Services (CMS) at the same time proposed coverage of the F1CDx. The test is the second IVD to be approved and covered after overlapping review by the FDA and CMS under the Parallel Review Program, which facilitates earlier access to innovative medical technologies for Medicare beneficiaries.
Compared to other companion diagnostics previously approved by the FDA that match one test to one drug, the F1CDx is a more extensive test that provides information on a number of different genetic mutations that may help in the clinical management of patients with cancer. Additionally, based on individual test results, the new diagnostic can identify which patients with any of five tumor types may benefit from 15 different FDA-approved targeted treatment options. Its results provide patients and health care professionals access to all of this information in one test report, avoiding duplicative biopsies.
CMS also issued a proposed national coverage determination of the F1CDx and other similar NGS IVDs for Medicare beneficiaries with advanced cancer (i.e., recurrent, metastatic or advanced stage IV cancer), who have not been previously tested using the same NGS technology and continue to seek further cancer therapy. The proposed national coverage determination provides coverage of NGS IVD tests to assist patients and their treating physicians in making informed cancer treatment decisions that improve health outcomes. Use of a test as a diagnostic also includes the ability to help patients and their treating physicians determine candidacy for cancer clinical trials.
This determination was made under the FDA-CMS Parallel Review Program, where the agencies concurrently review medical devices to help reduce the time between the FDA’s approval of a device and Medicare coverage. This voluntary program is open to certain premarket approval applications for devices with new technologies and to medical devices that fall within the scope of a Part A or Part B Medicare-benefit category and have not been subject to a national coverage determination.
The F1CDx detects gene mutations that may be found in any solid tumor and this information can be used by physicians according to professional guidelines to manage cancer patients. Moreover, it can be used as a companion diagnostic to identify patients with specific mutations who may benefit from certain FDA-approved treatments for non-small cell lung cancer, melanoma, breast cancer, colorectal cancer or ovarian cancer. Importantly, the F1CDx can detect genetic mutations that are indicated for multiple FDA-approved treatments, which extends beyond the previous “one test for one drug” model.
The device works by sequencing DNA from a patient’s tumor sample to determine the presence of gene mutations and alterations. It also detects certain molecular changes (microsatellite instability and tumor mutation burden). Clinical performance of the test was established through a least burdensome means by comparing the F1CDx to previously FDA-approved companion diagnostic tests that are currently used to determine patient eligibility for certain treatments. Results indicated that the test’s ability to detect select mutation types (substitutions and short insertions and deletions) representative of the entire 324 gene panel is accurate approximately 94.6 percent of the time.
The F1CDx had not been previously submitted for the FDA’s review because it is a laboratory-developed test, for which the agency has generally not enforced premarket review and other applicable requirements. However, at the test developer’s request, the FDA worked closely with them to help enter it into the agency’s newly established Breakthrough Device Program. Because of the test’s potential to consolidate multiple companion diagnostic claims for patients and health care providers in a single test, the F1CDx was granted Breakthrough Device designation. Under the Breakthrough Device Program, the FDA provides intensive interaction and guidance to the company on efficient device development, which expedites evidence generation and the agency’s review of devices that provide for more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases for which no approved or cleared treatment exists or that offer significant advantages over the existing standard of care.
See more about FoundationOne on Meddevicetracker.
December 1, 2017
Novocure Receives Reimbursement for Optune in Japan
Novocure announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the recommendation by Japan’s Central Social Insurance Medical Council (Chuikyo) to provide reimbursement for Optune for the treatment of newly diagnosed glioblastoma (GBM).
Optune is a noninvasive, portable device approved in Japan to treat newly diagnosed and recurrent GBM. Optune delivers Tumor Treating Fields (TTFields) to selectively disrupt mitosis in dividing cancer cells. Novocure’s Phase III Pivotal EF-14 trial compared Optune in combination with temozolomide to temozolomide alone in 695 patients with newly diagnosed GBM. The trial was designed to test both progression free survival (PFS) and overall survival (OS). The trial demonstrated unprecedented five-year survival results in newly diagnosed GBM. Patients treated with Optune in combination with temozolomide experienced a significant extension of overall survival without added systemic toxicity compared to patients treated with temozolomide alone. The data also showed that Optune-treated patients were able to maintain quality of life for longer compared to patients treated with temozolomide alone.
See more about Optune on Meddevicetracker.