Biomedtracker: 開発中医薬品をFDA承認確率で評価, Meddevicetracker: 医療機器の市場調...
What major drug catalysts and events can you expect to see this quarter? Get a view of what's to come with an extract from the full report.
January 17, 2017
REVEAL LINQ Insertable Cardiac Monitor Receives FDA Approval
Medtronic announced U.S. Food and Drug Administration (FDA) 510(k) clearance for its Reveal LINQ Insertable Cardiac Monitor (ICM) with TruRhythm Detection, an advanced cardiac monitor offering improved accuracy to better identify abnormal heartbeats. Reveal LINQ ICM with TruRhythm Detection offers exclusive algorithms that result in a 95 percent reduction in false bradycardia (slow heartbeat) episodes and a 47 percent reduction in false pause (brief absence of cardiac activity) episodes when compared with its predecessor, the Reveal LINQ ICM. The device also features a self-learning atrial fibrillation (AF - an irregular and often very fast heart rate) algorithm, which learns and adapts to a patient's heart rhythm over time.
See more information on REVEAL LINQ Insertable Cardiac Monitor on Meddevicetracker.
PQ Bypass Receives CE Mark for DETOUR Procedure Devices
PQ Bypass announced CE (Conformité Européenne) Mark approval for a trio of proprietary devices: TORUS Stent Graft System, PQ Snare, and PQ Crossing Device, which enables physicians to perform a fully percutaneous femoral-popliteal bypass in patients with TransAtlantic InterSociety (TASC) II C and D lesions in the superficial femoral artery due to peripheral artery disease (PAD). The company also refers to this procedure as the DETOUR procedure. The TORUS Stent Graft System is an expanded polytetrafluoroethylene (ePTFE) covered self-expanding nitinol stent intended to improve blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery de novo and restenotic TASC II C and D lesions. The PQ Snare and PQ Crossing Devices are intended for the retrieval and manipulation of atraumatic foreign bodies in the distal peripheral vasculature and to support the placement and positioning of guidewires in the peripheral vasculature, respectively. The company also announced it is looking forward to conducting an IDE study in preparation for FDA approval.
March 14, 2017
Expanded Indication Approved for the Melody Transcatheter Pulmonary Valve
Medtronic announced that its Melody Transcatheter Pulmonary Valve (TPV) received approval from the United States Food and Drug Administration (FDA) for implantation in patients whose surgical bioprosthetic pulmonary heart valves have failed. Designed specifically for the pulmonic position, Melody TPV is the first transcatheter pulmonary valve to receive this approval in the U.S. The Melody TPV first received CE Mark in September 2006 for the treatment of failing pulmonary valve conduits. It was introduced in the U.S. in 2010 following FDA approval. This expanded indication expands the treatment options to more patients with Congenital Heart Disease by providing them with a minimally invasive treatment option.
See more information on Melody Transcatheter Pulmonary Valve on Meddevicetracker.
Medtronic Issues Class I Recall for SynchroMed Pumps
Medtronic issued a Class I recall for its SynchroMed Implantable Infusion Pumps because a software problem may cause unintended delivery of drugs during a priming bolus procedure, used to quickly deliver large dose of medication from the device to the patient’s spine. During this procedure, patients may receive the drug unintentionally at a high rate of infusion in the cerebrospinal fluid followed by a period of reduced drug delivery after the priming bolus. This can result in a drug overdose or under dose which can lead to serious adverse health consequences such as respiratory depression, coma or death. The SynchroMed Pumps are used to provide precise drug delivery for chronic therapy for severe spasticity. The device received approval form the U.S. Food and Drug Administration for chronic intravascular infusion of floxuridine (fudr) or doxorubicin hydrochloride (adriamycin) and, when required bacteriostatic water, physiological saline and/or heparin in March 1988. The company is currently seeking clearance for FDA approval for the Remodulin Implantable System (RemoSynch) and labeling changes for the SynchroMed II pump indicated for Pulmonary Arterial Hypertension, however, in March 2016, the FDA issued a non-approvable letter for the device. In October 2016, Medtronic submitted additional information to supplement its premarket approval application (PMA) with FDA and is currently awaiting an approval decision.
See more information on RemoSynch on Meddevicetracker.
Stryker Launches MAKO Robotic Surgery System at AAOS
Stryker announced the commercial launch of the robotic-arm assisted total knee arthroplasty application for use with its Mako System at the American Academy of Orthopaedic Surgeons (AAOS) annual meeting in San Diego. This latest advancement distinguishes the Mako System as the first and only robotic technology that can be used across the joint replacement service line to perform total knee, total hip and partial knee replacements.
Mako Total Knee combines Stryker's advanced robotic technology with its clinically proven Triathlon Total Knee System (GetAroundKnee), enabling surgeons to have a more predictable surgical experience with increased accuracy. Through CT-based 3D modeling of bone anatomy, surgeons can use the Mako System to create a personalized surgical plan and identify the implant size, orientation and alignment based on each patient's unique anatomy. The Mako System also enables surgeons to virtually modify the surgical plan intra-operatively and assists the surgeon in executing bone resections.
See more information on MAKO Robotic Surgery System on Meddevicetracker.
Corin Launches Optimized Positioning System at AAOS
Corin announced the U.S. launch of its Optimized Positioning System (OPS) System at the American Academy of Orthopaedic Surgeons (AAOS) in San Diego.
Utilizing pre-operative functional simulation and planning and a unique intra-operative positioning system that employs 3D printing and laser guidance, OPS helps surgeons determine the best position and orientation for a hip implant based on specific patient anatomy and movement. The device consists of a dynamic, functional and patient specific pre-operative simulation and a patient specific delivery system. The Corin OPS received 510(k) clearance from the U.S. Food and Drug Administration in June 2016.
See more information on Corin OPS on Meddevicetracker.
March 15, 2017
Biocartis Receives Grant for Development of a Fully Automated MSI Test
Biocartis announced it has received an approximately EUR 750k grant from VLAIO, the Flanders organization for Innovation & Entrepreneurship. The grant supports Biocartis’ ongoing microsatellite instability (MSI) and mutational load research program in collaboration with Professor Diether Lambrechts (VIB – KU Leuven Center for Cancer Biology, Belgium), and aims to support the development of a fully automated MSI test on the Company’s Idylla platform. The test will be based on a set of novel MSI markers identified by Professor Diether Lambrechts’ laboratory, which were exclusively licensed to Biocartis from VIB in December 2013. The Idylla MSI Test under development will operate directly on a single slice of FFPE6 tissue from human CRC tissue. This without the need for a second slice used for control, as required for Bethesda method based testing. With this grant, Biocartis expects it will be able to develop an easy, rapid and highly accurate standardized MSI test, available to a much larger patient population.
See more information on Idylla MSI Test on Meddevicetracker.
InVivo Receives Approval to Commence Clinical Studies in the United Kingdom
InVivo Therapeutics announced that the Medicines Healthcare Products Regulatory Agency (MHRA) has approved the company’s Clinical Trial Authorization Application to commence clinical studies in the United Kingdom (UK). The approval will allow the company to enroll patients from the UK into the ongoing INSPIRE study once InVivo receives a favorable opinion from a Research Ethics Committee (REC), Health Regulatory Approval (HRA), and a site is open for enrollment. InVivo currently is in late-stage conversation with various clinical sites, and its first UK site opening should occur in the coming weeks.
The INSPIRE study is currently enrolling subjects in the US and Canada. The study is evaluating the company’s Neuro-Spinal Scaffold device for the probable benefit for safety and neurologic recovery in subjects with complete thoracic AIS A Spinal Cord Injury. The study began enrolling patients in April 2014. This device is not yet approved in the United States.
See more information on Neuro-Spinal Scaffold on Meddevicetracker.
March 16, 2017
DePuy Synthes Mitek Sports Medicine Launches New Knee Arthroscopy Products
DePuy Synthes Mitek Sports Medicine has launched a new suite of knee arthroscopy solutions to help improve operating room efficiency, simplify ACL and meniscus repair, and make these surgeries more reproducible. The announcement was made at the 2017 American Academy of Orthopaedic Surgeons Annual Meeting.
The new suite of products from Mitek Sports Medicine is designed to promote operating room efficiency and simplicity from the start to finish of the procedure, together with implants that may help promote stability:
• The SPEEDTRAP Graft Prep System allows the surgeon to easily and quickly whipstitch, or suture, one tendon end without using a needle in about 20 seconds, which is at least 77 percent faster than traditional techniques and offers strong tension.
• The TRUESPAN Meniscal Repair System streamlines arthroscopic meniscal repair by offering a unique delivery system with an ergonomic handle, single trigger, and auto-reloading mechanism for quick, simple one-handed use. The TRUESPAN System also features the only 24-degree curved needle option on the market, which may provide better access to challenging tear locations.
• The RIGIDLOOP Adjustable Cortical System, a titanium cortical button and adjustable loop implant, holds the graft in place in the femoral tunnel. The innovative design with adjustable loops eliminates need for multiple size implants. Simple one-handed tensioning technique allows surgeons to advance graft to completely fill the socket withstronger fixation and less graft displacement compared to similar adjustable loop devices.
• The INTRAFIX ADVANCE Tibial Fastener System provides rigid fixation of the graft in the tibial tunnel. The sheath and screw implant duo is designed to protect soft tissue grafts and promote integration with the surrounding bone to achieve a strong and stable fixation.
March 17, 2017
Medtronic Presents Top-Line Data from SURTAVI Clinical Study
Medtronic announced top-line clinical data from the Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) Trial, which was presented at the American College of Cardiology (ACC) 66th Annual Scientific Session. Data from the trial showed the Medtronic self-expanding TAVR platform met its primary endpoint of all-cause mortality or disabling stroke at two years. Rates of all-cause mortality or disabling stroke at two years were similar to surgical aortic valve replacement (SAVR) (12.6 percent for TAVR versus 14.0 percent for SAVR; posterior probability of non-inferiority >0.999). The minimally-invasive TAVR procedure also demonstrated significantly better mean aortic valve gradient (7.8 mm Hg vs. 11.8 mm Hg; p<0.001) at two years, while neither TAVR- nor SAVR-treated patients displayed evidence of structural valve deterioration at two years.
The Recapturable CoreValve Evolut R System is similar to the CoreValve Evolut, with the main change being the way it interacts with the delivery system to make it recapturable. The CoreValve Evolut R consists of the CoreValve Evolut R transcatheter aortic self-expanding valve system and the EnVeo R Delivery Catheter System. The reinforced self-expanding nitinol frame with distal flare provides structural support needed to recapture and reposition as well as self-centers in the annulus.
What were the outcomes of critical catalysts featured in Meddevicetracker’s Q3 2019 Outlook Report? Find out in the Catalyst Roundup: A Review of Select Catalysts from Last Quarter’s Outlook Report. This data-rich graphic is available now – for free.
Topics Drug approval
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