May 1, 2017
Axxent Electronic Brachytherapy System launched in Australia
iCAD announced that the first early-stage breast cancer patient in Australia was treated with intraoperative radiation therapy (IORT) using the Axxent Electronic Brachytherapy (eBx) System. Originally developed by Xoft, which was acquired by iCAD in December 2010 for approximately $13.1 million, Axxent eBx is an isotope-free radiation system for the treatment of early-stage breast cancer, gynecological cancers and non-melanoma skin cancer. Room redesigns or construction investments to accommodate these systems are not necessary since it does not utilize a radioactive source or HDR isotope afterloader, requiring minimal shielding. Included in the system is a mobile platform controller that is responsible for the overall operation of the device. Radiation is delivered by a disposable, microminiature X-ray source located at the end of a flexible cable. The X-ray source at the distal tip of the cable is inserted into the central lumen of an appropriately-sized balloon applicator. The system is designed to deliver doses of X-ray radiation directly to the excised tumor bed when the physician desires to deliver intracavitary or interstitial radiation to the surgical margins. The Axxent Brachytherapy System received 510(k) Clearance from the U.S. Food and Drug Administration (FDA) in December 2005 and CE mark approval in September 2010 for marketing and distribution of the system in Europe.
See more information on the Axxent Electronic Brachytherapy System on Meddevicetracker.
VENTANA PD-L1 Assay Approved by U.S. FDA as a Complementary Diagnostic for Bladder Cancer
The U.S. Food and Drug Administration (FDA) granted AstraZeneca approval for IMFINZI (durvalumab, MEDI-4736) for the treatment of patients with locally advanced or metastatic urothelial carcinoma. The FDA also approved Roche’s VENTANA PD-L1 (SP263) Assay as a complementary diagnostic for the assessment of the PD-L1 protein in formalin-fixed, paraffin-embedded urothelial carcinoma tissue to screen for patients who may benefit from IMFINZI. Complementary diagnostics differ from companion diagnostics in that they are not required for the safe and effective use of a drug, but do provide additional information about how a drug might be used or whether a patient should receive a class of drugs. In 2014, Roche’s Ventana Medical Systems and AstraZeneca’s MedImmune initially formed a partnership to jointly develop this PD-L1 immunohistochemistry assay to help test MedImmune’s anti-PD-L1 immunotherapy MEDI-4736 for non-small cell lung cancer (NSCLC). The SP263 assay is classified as a companion diagnostic for use with durvalumab in the treatment of NSCLC, a complementary diagnostic for use with durvalumab in the treatment of Bladder Cancer, and a complementary diagnostic for use with Opdivo in the treatment of NSCLC.
See more information on the VENTANA PD-L1 (SP263) Complementary Assay on Meddevicetracker.
May 2, 2017
LivaNova Acquires Caisson Interventional
LivaNova announced that it has acquired the remaining outstanding interests in Caisson Interventional, a clinical-stage medical device company focused on the design, development and clinical evaluation of a novel transcatheter mitral valve replacement (TMVR) implant with a fully transvenous delivery system. Intended for the severe treatment of symptomatic mitral valve regurgitation, the Caisson TMVR implant consists of a pericardial tissue valve attached to a Nitinol frame that serves as an anchor. The implant is fully repositionable and retrievable and only released after the function of the implant is fully assessed. The entire procedure is completed through a single percutaneous femoral venous access utilizing a trans-septal approach to the native mitral valve. Although the TMVR system has not been approved in any country, Caisson expects to receive CE Mark approval for the system in late 2018 or early 2019 and U.S. Food and Drug Administration (FDA) approval several years after obtaining a CE Mark. LivaNova began investing in Caisson in 2012 and as part of their planned entry into the TAVR space, agreed to pay Caisson up to $72 million, net of $6 million of debt forgiveness, to acquire the remaining 51 percent of the company. The first payment of $18 million was made at closing with the balance paid on a schedule driven primarily by regulatory approvals and sales earn outs.
See more information on LivaNova and the Caisson TMVR System on Meddevicetracker.
May 3, 2017
Novo Nordisk Launches Xultophy Pen in the United States
Novo Nordisk, a healthcare company with experience in diabetes care, haemophilia care, hormone therapy and hormone replacement therapy, announced the availability of its combination therapy Xultophy 100/3.6 in the United States. Xultophy is an insulin injection with a fixed ratio combination of a basal insulin, degludec, and GLP-1 compound, liraglutide. The injection is delivered subcutaneously through a pre-filled disposable injection pen that contains a dose step counter with each step containing 1 unit of insulin degludec and 0.036 mg of liraglutide. Xultophy is intended as an adjunct to diet and exercise to improve glycaemic control in adults with type II diabetes mellitus inadequately controlled on basal insulin (less than 50 units daily) or liraglutide (less than or equal to 1.8 mg daily). Since the Xultophy pen is regulated as a drug-device combination product through the NDA/BLA pathway in the U.S., the pen was approved through the U.S. Food and Drug Administration’s (FDA) approval of the Xultophy combination therapy in November 2016.
See more information on the Xultophy Pen on Meddevicetracker.
May 4, 2017
Cardiovascular Systems Receives Supplemental PMA Approval for Diamondback 360 OAS Saline Infusion Pump
Cardiovascular Systems (CSI) announced that the U.S. Food and Drug Administration (FDA) has approved its premarket approval application (PMA) supplement for a redesigned saline pump used as part of the company’s Diamondback 360 Orbital Atherectomy Systems (OAS). The 70057-03 Saline Infusion Pump will replace CSI’s 7-10014 Saline Infusion Pump, which the company voluntarily recalled on April 17, 2017. The Saline Infusion Pumps provide saline and lubricant infusion during orbital atherectomy procedures and electrical power to the orbital atherectomy device. CSI has determined that electromagnetic interference present in the hospital environment may cause the Pumps to switch to standby mode during use, requiring the Pump to be reset prior to continuing treatment. Restoring Pump operation can result in a temporary delay in the orbital atherectomy procedure. In coronary artery procedures, this delay of therapy could present an additional risk of a temporary, medically reversible injury. However, there have been no reports of patient injury to date. The company plans to recall and replace approximately 900 units currently in customer inventory. The Diamondback 360 OAS is a hand-held device that is intended to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for percutaneous transluminal coronary angioplasty (PTCA) or stenting due to de novo, severely calcified coronary artery lesions. The system was originally approved in the United States in October 2013.
See more information on the Diamondback 360 Coronary Orbital Atherectomy System on Meddevicetracker.
Medtronic Expands HVAD Class I Recall
Medtronic expanded a previous Class I recall of the HeartWare Ventricular Assist Sytem (HVAD) Controllers and DC Adapters to include an additional product code for the HVAD DC adapter and provide instructions to exchange the recalled products. The HeartWare Ventricular Assist Device (HVAD) helps deliver blood from the heart to the rest of the body. It is used in patients who are at risk of death from end-stage left ventricular heart failure and who are waiting for a heart transplant. Since the acquisition of HeartWare by Medtronic in August 2016, the HVAD has been plagued by a string of formal corrections and removals from the U.S. Food and Drug Administration (FDA). This expanded recall was initially issued in November 2016 due to a loose power connector in the HVAD controller which may cause the rear portion of the pumps’ driveline connector to become separated from the front portion of the driveline connector. A loose connector may allow moisture to enter the controller causing corrosion, electrical issues, reduced speaker volume and connection failures. If the speaker volume is decreased, the patient may not hear the alarm. If there is a loss of connection, the pump may stop which could cause serious adverse health consequences, including death. Medtronic has developed an updated HVAD controller and power management software to address the power connector issues.
See more information on the HeartWare Ventricular Assist System on Meddevicetracker.
May 5, 2017
MDxHealth and Maastricht University Expand R&D Collaboration to Develop (Epi)genetic Cancer Diagnostics
MDxHealth announced that it has signed an agreement with the Faculty of Health, Medicine and Life Sciences/School for Oncology and Developmental Biology (GROW) at Maastricht University to expand its existing research collaboration to develop commercial next generation (epi)genetic cancer diagnostics. Under the terms of the multi-year R&D agreement, the collaboration will focus on developing (epi)genetic-based assays to provide better insight in the diagnosis, staging and treatment of cancer patients. For these next generation assays, the focus will be on sample in and result out based platforms. This technology would also be applied to MDxHealth's current and upcoming liquid biopsy tests including SelectMDx for Prostate Cancer. GROW focuses on research and teaching of (epi)genetic and cellular concepts, as well as (micro)environmental factors underlying normal and abnormal development. MDxHealth provides actionable molecular diagnostic information to personalize the diagnosis and treatment of cancer.
See more information on the (Epi)genetic Cancer Diagnostic and SelectMDx on Meddevicetracker.