Meddevicetracker Weekly Roundup
March 5-9, 2018
March 5, 2018
DePuy Synthes Announces Agreement with SERF to Add Dual Mobility System to Its Hip Portfolio
DePuy Synthes plans to add a dual-mobility acetabular cup to its hip portfolio as a result of an agreement between DePuy Ireland Unlimited Company and SERF (Société d’Etude, de Recherche et de Fabrication).
Dual-mobility acetabular cups are designed to increase the stability of the hip implant in patients with a higher risk of dislocation. They feature a standard femoral head articulating within a large polyethylene liner which articulates within a metal shell. These two points of articulation are designed to reduce the risk of dislocation which can impact patient satisfaction, and dual-mobility cups may also reduce the incidence of costly revisions.
Per the agreement, DePuy Synthes plans to provide the latest SERF dual-mobility acetabular cup under its own brand name to global markets beginning in the latter half of 2018 subject to regulatory approvals in the US and Europe (additional registrations in certain other geographies are planned to follow).
See more about the Serf NOVAE Dual Mobility on Meddevicetracker.
Endologix Announces Enrollment of the First Patient in EVAS2 IDE Clinical Study of the Nellix Endovascular Aneurysm Sealing System
Endologix announced that the first patient was treated in the EVAS2 IDE Confirmatory Clinical Study of the investigational Nellix EndoVascular Aneurysm Sealing (EVAS) System by Sajjad M. Hussain, M.D., Chief of the Department of Vascular Surgery at St. Vincent Health and St. Vincent Heart Center of Indiana.
The Nellix System is an endovascular abdominal aortic aneurysm (AAA) therapy designed to seal the entire aneurysm. Nellix was developed as an alternative treatment approach to traditional EVAR devices. The Nellix System has received a CE Mark and is commercially available in many markets, including the EU.
EVAS2 is an IDE-approved confirmatory clinical study, which is designed to evaluate the safety and effectiveness of the second-generation Nellix System and the refined Indications for Use (IFU). The study is approved to enroll up to 90 primary patients at 28 U.S. centers, with one-year follow-up data required for the Pre-Market Approval (PMA) application.
The Company said that based on anticipated enrollment, follow-up, and typical regulatory review timelines, it continues to estimate a decision on the PMA by the end of 2020.
See more about the Nellix Endovascular Aneurysm Sealing System on Meddevicetracker.
Admedus Receives Regulatory Approval to Launch CardioCel 3D and VascuCel in Canada
Admedus announced that it has received regulatory approval to introduce its products, CardioCel 3D and VascuCel, in Canada, alongside its flagship product, CardioCel, which is already available.
CardioCel 3D is the latest product from Admedus’ proprietary ADAPT portfolio for high-complexity congenital defect repair and was officially launched in the United States on February 1, 2018. CardioCel 3D has a pre-shaped curve, which provides physicians immediate access to an off-the-shelf arch reconstruction solution with non-antigenic response and calcification resistance.
Canada is the second market to have access to this technology and the first executed stage of the Company’s expansion strategy for the shaped-tissue franchise. CardioCel 3D and VascuCel will be sold in Canada through Admedus’ usual distribution network.
March 6, 2018
FDA Approves the World’s Smallest Mechanical Heart Valve for Pediatric Patients with Heart Defects
The U.S. Food and Drug Administration (FDA) expanded the approval of a heart valve to include a size small enough to be used in newborn pediatric patients to treat heart defects. Specifically, the agency approved the Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff to include the 15-mm valve size, making it one of the smallest mechanical heart valves approved in the world.
The Master Series Mechanical Heart Valve is a rotatable, bileaflet (two-leaflet) valve designed for implantation in the aortic or mitral position. The bileaflet design consists of two semi-circular discs that open and close in response to blood pressure changes during the heartbeat, similar to a patient’s own valve.
The Masters Series Mechanical Heart Valve was first approved in November 1995 for patients with a diseased, damaged or malfunctioning aortic or mitral heart valve. The device is also approved for use in replacing previously implanted aortic or mitral prosthetic heart valves. This new approval expands the range of valve sizes available, providing smaller patients another treatment option.
The FDA evaluated clinical data from a single-arm study of 20 pediatric patients with serious heart failure ranging in age from 1.5 weeks to 27 months at the time of mitral valve implant. The data showed that one year after the implant procedure, the probability of survival was 69.3 percent and the probability of not experiencing a valve-related adverse event was 66.8 percent. Serious valve-related adverse events observed during the study through one-year follow-up included blood clots in the device and bleeding in the brain. Anticoagulation (blood thinning) therapy may be necessary after the procedure, to prevent clotting on the device, which can increase the risk of bleeding.
The Master Series Mechanical Heart Valve should not be used by patients unable to tolerate anticoagulation therapy.
See more about the Masters HP on Meddevicetracker.
Smith & Nephew Announces the Launch of the Q-Fix and SUTUREFIX Curved All-Suture Anchor Systems
Smith & Nephew announced the launch of Q-FIX CURVED, Q-FIX MINI and SUTUREFIX CURVED All-Suture Anchor systems, adding to its Sports Medicine portfolio. Designed for procedures where space is limited and the anatomy can be difficult to access, the new SUTUREFIX CURVED, Q-FIX CURVED and MINI delivery systems are designed to aid in suture anchor placement during drilling and insertion.
The SUTUREFIX CURVED and Q-FIX CURVED systems improve access and trajectory when drilling bone tunnels. Both systems optimize the curved geometry of the drill guide while also maximizing drilling accuracy. The incorporation of both visual and tactile cues simplifies drill guide orientation for the surgeon and helps to indicate drilling trajectory.
The Company also introduced its Q-FIX MINI All-Suture Anchor, which reduces the tunnel drill depth and implant length to 17.1mm, making it one of the shortest all-suture anchors in its class.
Smith & Nephew’s Q-FIX and SUTUREFIX All-Suture Anchor platform uses active deployment, which eliminates manual tensioning and makes deployment more reliable, ultimately resulting in improved biomechanical performance among all-suture anchors.
DePuy Synthes Announces the Launch of the ATTUNE Revision Knee System
DePuy Synthes announced the US launch of the ATTUNE Revision Knee System, to complement the ATTUNE Primary Knee System and provide surgeons with a comprehensive solution for knee replacement. The ATTUNE Revision Knee System is being introduced at the 2018 American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting from March 6-10 in New Orleans, LA.
In a large, multi-center study, the ATTUNE Primary Knee System demonstrated improved outcomes across a broad range of Patient Reported Outcome Measures (PROMs) compared to certain existing knee brands at one-year minimum follow-up. The same technologies that helped deliver these outcomes are also incorporated in the ATTUNE Revision Knee System, helping to address overall patient satisfaction.
The ATTUNE Revision Knee System is designed to work in harmony with the patient’s anatomy to deliver stability in motion during activities such as stair ascent or descent, walking uphill or downhill or getting up from a chair through:
The ATTUNE Revision Knee System is now available in the US.
See more about the ATTUNE Knee System on Meddevicetracker.
March 7, 2018
Orthofix Secures FDA and CE Mark Approvals for New PhysioStim Bone Growth Stimulators
Orthofix International announced it received CE Mark approval for its next-generation PhysioStim bone growth stimulators.
The PhysioStim devices provide a non-surgical treatment option for patients who have a nonunion fracture to an extremity that has shown no visible signs of healing. These Class III medical devices use a pulsed electromagnetic field (PEMF) signal to induce a low-level electrical field at the fracture site which stimulates bone healing.
The PhysioStim devices will be accompanied by a new application for mobile devices, STIM onTrack. Designed for use with smartphones and other mobile devices, STIM onTrack includes a first-to-market feature that enables physicians to remotely view patient adherence to their prescription. Additionally, the app engages patients in their recovery process through treatment calendars, therapy reminders and educational resources.
The PhysioStim devices come in different models and are designed to anatomically fit the patient’s body. Specific applications are for treatment of nonunion fractures to the arm, hand, wrist, clavicle, shoulder, hip, thigh, lower leg, ankle or foot. The devices can be worn over clothing, casts or internal and external surgical fixation devices.
See more about the Physio-Stim on Meddevicetracker.
FDA Confirms Date to Providing Regulatory Guidance for Auquus’ Anti-Nausea Patch
Aequus Pharmaceuticals announced that the Company has received confirmation from the US Food and Drug Administration (FDA) that they will be providing feedback to the Company’s pre-Investigational New Drug (pre-IND) submission by the end of April 2018 to define the clinical strategy for regulatory approval in the US for AQS1303.
Aequus’ long-acting transdermal anti-nausea patch, AQS1303, contains the combination of pyridoxine and doxylamine (the active ingredients in Diclegis/Diclectin). AQS1303 is designed to provide patients with a more convenient and reliable delivery system as an alternative to the currently marketed oral form, which is dosed up to four times per day.
The product is expected to follow a Section 505(b)2 New Drug Application (NDA), an abbreviated clinical pathway in which the FDA would allow for the Company to reference safety and efficacy data of the original oral tablet form of the medication. Aequus owns the global rights to this program, and will look to find a strategic partner to advance towards commercialization in major markets.
The Company issued Camargo Pharmaceutical Services, LLC 59,038 common shares on March 7, 2018 in connection with this milestone regulatory event as per a previously announced service agreement to provide regulatory consulting services for the Company’s product development programs in the United States.
See more about the AQS-1303 Patch on Meddevicetracker.
As this product is classified as drug delivery technology, the full development history of AQS-1303 can be seen on Biomedtracker.
Contego Medical Announces the Start of Enrollment in the PERFORMANCE I Trial
Contego Medical announced the beginning of enrollment in the PERFORMANCE I Trial, a clinical trial designed to evaluate the safety and feasibility of the Neuroguard IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection. The Neuroguard IEP System is designed to treat clinically significant carotid artery stenosis, further expanding Contego Medical’s portfolio of neurovascular solutions.
Prof. Saško Kedev, M.D., Ph.D., of University Clinic of Cardiology in Skopje, Macedonia treated the first patient enrolled in the PERFORMANCE I Trial.
The Neuroguard IEP System contains a novel, next-generation nitinol stent, a pre-positioned post-dilation balloon and an integrated microembolic filter with 40 μm pores. The stent has a closed-cell design for optimal balance of radial strength and flexibility. The stent is flared at both ends to facilitate ideal wall apposition in tortuous anatomy. The integrated filter is designed to capture both macro- and micro-emboli during the entire intervention. All components are mounted on a 6 French delivery system.
See more about the Neuroguard IEP System on Meddevicetracker.
March 8, 2018
InVivo Therapeutics Receives FDA Approval for Pivotal, Randomized, Controlled Trial of the Neuro-Spinal Scaffold in patients with Acute Spinal Cord Injury
InVivo Therapeutics announced that the company has received supplemental Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA) for a second pivotal clinical study of the company’s Neuro-Spinal Scaffold in patients with acute spinal cord injury (SCI). The 20-patient (10 subjects in each study arm), randomized, controlled trial is designed to enhance the existing clinical evidence for the Neuro-Spinal Scaffold from the company’s single-arm INSPIRE study (InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury). The definition of study success is that the difference in the proportion of subjects who demonstrate an improvement of at least one grade on AIS assessment at the six-month primary endpoint follow-up visit between the Scaffold Arm and the Comparator Arm must be equal to or greater than 20%.
InVivo recently reported that seven of 16 (43.8%) evaluable patients in the INSPIRE study experienced an improvement in AIS grade from baseline at six months compared to the Objective Performance Criterion (study success definition) of 25% of patients. Of these seven patients, three of five individuals who had converted from AIS A SCI (complete) to AIS B SCI (sensory incomplete) in the first six-month period of follow-up subsequently further improved to AIS C SCI (motor incomplete) within 12 to 24 months, including a recent patient who converted from AIS B to AIS C at the 12-month exam in January 2018.
See more about the Neuro-Spinal Scaffold on Meddevicetracker.
FDA Grants Breakthrough Device Designation to Polyganics’ Liver and Pancreas Sealant Patch
Polyganics announced that the US Food and Drug Administration (FDA) has granted Polyganics’ request for Breakthrough Device designation to its Liver and Pancreas Sealant Patch. The Liver and Pancreas Sealant patch is considered a unique breakthrough in the prevention of fluid leakage after hepato-pancreato-biliary (HPB) procedures, for which currently no approved or cleared alternatives exist.
The Liver and Pancreas Sealant Patch is made of Polyganics’ proprietary bioresorbable and biologically safe polymers, designed to seal-off the surgically treated tissue during the critical healing period. The polymer formulation of the Liver and Pancreas Sealant has been optimized specifically for HPB surgery, withstanding the interference of aggressive bile and pancreatic fluids. It aims to prevent post-operative leakage of fluids from the site of surgery into the abdominal cavity after HPB surgery, and as an adjunctive hemostatic device to control minimal to moderate bleeding.
A ‘Breakthrough Device’ is a device that may prevent or treat a life-threatening or irreversibly debilitating disease or condition. Under the Breakthrough Devices program, the FDA will provide its support to advance the Liver and Pancreas Sealant Patch from development to marketing decision. As part of this, the FDA is committed to be closely involved in the design of efficient and flexible clinical trials, as well as the collection of pre- and post-market data. It is anticipated that this support, combined with priority review, will enable a reduced regulatory timeline.
See more about the Liver and Pancreas Sealant Patch on Meddevicetracker.
February 9, 2018
FDA Approves Pivotal Clinical Trial for Technology to Treat Overactive Bladder
Valencia Technologies announced that the U.S. Food and Drug Administration (FDA) approved the conduct of a pivotal clinical trial using a new technology to treat overactive bladder. The technology, developed and manufactured by Valencia Technologies, is called eCoin. It works by sending out electrical impulses to the tibial nerve which takes these signals to the part of the brain that controls bladder response.
The device is about the size of a US nickel and is implanted in a ten minute in-office procedure. The physician who cares for incontinence patients, a urologist or urogynecologist, does the procedure under local anesthetic. The protocol approved by the FDA shows Valencia will attempt to prove that its device produces superior effectiveness to the published results of a leading drug. If proven, patients will have an effective alternative to drugs currently on the market—without side-effects.
The pivotal clinical trial will be conducted at 20 different medical centers throughout the US.
See more about eCoin on Meddevicetracker.
Oncology Venture Proposes Merger with Medical Prognosis Institute
Medical Prognosis Institute and Oncology Venture Sweden jointly announced that their respective Boards of Directors have agreed on a joint merger plan (the Merger Plan) to accomplish a merger of the companies (the Merger). The Merger will be implemented with MPI as the continuing legal entity and OV as the discontinuing entity. Following completion of the merger the combined company will be referred to as 'Oncology Venture'. The Merger is conditional upon, inter alia, approvals at the extraordinary general meetings of both companies. Oncology Venture's shareholders will receive as merger consideration 1.8524 shares in Medical Prognosis Institute for each share in OV. Above 50 percent of the shareholders in OV and above 70 percent of the shareholders in MPI, have undertaken or declared their intention to vote in favor of the Merger at their respective upcoming extraordinary general meetings.
The Boards of Directors of Oncology Venture and MPI have identified strategic and operational rationales for a merger, based on the companies' complementary business models, business relations and degree of interdependence, as well as the overlaps in terms of ownership structures and executive management teams.
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