Intact Vascular Receives Supplemental IDE Approval for Tack Endovascular System
Intact Vascular is currently developing the Tack Endovascular System, a new option for physicians to treat peripheral artery disease. The system is designed to spot-treat dissections following plain old balloon angioplasty (POBA) and drug-coated balloon (DCB) angioplasty in peripheral arteries while incurring minimal stress to the vessels. This focused treatment option allows the physician to use less than 70% of metal compared to stenting, which significantly decreases the amount of foreign material introduced into the artery, reducing inflammation. Using less metal produces less force on the artery walls, yielding better healing and preserving retreatment options.
Intact announced that the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE) supplemental application to modify the primary endpoint, freedom from major adverse limb events (MALE) in the Tack Optimized Balloon Angioplasty II Below the Knee (TOBA II BTK) clinical trial from 12 months to 6 months. The FDA first granted IDE approval to begin this prospective, multi-center, single-arm study in October 2016 to examine the safety and efficacy of the Tack Endovascular System when used to repair dissections (or tears) in the arteries below the knee (BTK) following percutaneous transluminal angioplasty (PTA) as a treatment for critical limb ischemia (CLI). According to the Company, the TOBA II BTK study, which enrolled its first patient in February 2017, is the first known industry-sponsored pivotal clinical trial approved by the FDA to investigate a permanent vascular implant in arteries below the knee. Additionally, the Tack Endovascular System is being evaluated in two other company-sponsored studies: TOBA II, which is investigating the combination of the Tack device with both plain and drug-coated balloon angioplasty in the arteries above the knee, and TOBA III, which is currently underway in Europe and is investigating the combination of the Tack Endovascular System with drug-coated balloon angioplasty. The system was granted ISO Certification and CE Mark approval for treatment of peripheral artery disease in April 2012 and another CE Mark in January 2017 to include the repair of arterial dissections following PTA below the knee.
See more on the Tack Endovascular System on Meddevicetracker.
July 11, 2017
DePuy Synthes Launches Distal Radius Sterile Kit in the U.S.
DePuy Synthes, a division of Johnson & Johnson, announced that it launched its Distal Radius Sterile Kit in the United States. The Distal Radius Sterile Kit is a pre-sterilized, single-use kit of instruments and implants to treat wrist fractures. The streamlined kits are designed to help optimize operating room efficiency and eliminate procedural sterilization costs. The Kit consists of one Variable Angle LCP (locking compression plate) Two-Column Volar Distal Radius Plate, a variety of screws, and the required fixation instrumentation.
In February 2017, the kit was cleared by the U.S. Food and Drug Administration (FDA) to treat intra- and extra-articular fractures, osteotomies, nonunions and malunions of the distal radius, with or without extension into the radial diaphysis in adults and adolescents (ages 12-21) where the growth plates have fused or will not be crossed, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius. DePuy has also mentioned that the kit has received CE Mark approval for wrist fracture surgery in Europe.
See more on the Distal Radius Sterile Kit on Meddevicetracker.
July 12, 2017
BioTelemetry Completes Acquisition of LifeWatch AG
BioTelemetry, formerly known as CardioNet, announced that it completed its acquisition of LifeWatch AG. BioTelemetry is a wireless medical technology company focused on the delivery of health information to improve quality of life and reduce cost of care. It currently provides cardiac monitoring services and original equipment manufacturing with a primary focus on cardiac monitoring devices and centralized cardiac core laboratory services.
LifeWatch is focused on the development of comprehensive cardiac monitoring technologies and diagnostic services for the detection of atrial fibrillation (AFIB), and other heart rhythm disorders. It has developed remote cardiac monitoring diagnostic services that allow timely access to patient arrhythmia data and facilitate the exchange of patient data and help improve remote monitoring management. They also offer specialized monitoring programs for post-AFIB procedures and for patients who have experienced a cryptogenic stroke or transient ischemic attack (TIA). The Company’s pipeline includes the Holter Plus MCT, a device that detects and quantifies up to 30 days of mobile cardiac telemetry data from one software-defined device; the LifeWatch MCT 1 Lead Patch (MCT 1LP), a patient-friendly system designed with a light and flexible hydrocolloid patch to ensure high levels of comfort and convenience while detecting and wirelessly transmitting cardiac data in real time to LifeWatch for analysis; and LifeWatch MCT 3 Lead (MCT 3L), a cardiac monitor that provides three distinct views of the heart for more specific and sensitive diagnostic value.
See more on BioTelemetry on Meddevicetracker.
Tyber Medical Receives 510(k) Clearance for TyFix All-in-One Extremity Joint Fixation Device
Tyber Medical, a company focused on the development and marketing of orthopaedic and spinal implants, announced that its TyFix All-in-One Extremity Joint Fixation device received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The TyFix system eliminates the use of the ancillary instrumentation for a wide range of bone fixation procedures, including hammertoe correction. The system delivers intraoperative flexibility by offering solid and cannulated implants with diameters ranging from Ø1.5 - 4.0mm in multiple lengths as well as a straight and an angled 10-degree option. The integrated implant/instrument design creates value by minimizing the number of procedure steps, improving operating room efficiency, and significantly reducing procedure time. In addition, the all-in-one sterile-packed device eliminates traditional reprocessing costs.
The system includes the single-use TyFix Screw, also known as the BioTy Nanotopography Trauma Screw, which combines a highly optimized bone thread with a barbed head to maximize bone purchase and compression in both the proximal and distal phalanges. In June 2017, Tyber received 510(k) clearance from the FDA for the TyFix Screw, indicated for use in bone reconstruction, osteotomy, arthrodesis, and joint fusion appropriate for the size of the device.
See more on the TyFix on Meddevicetracker.
July 13, 2017
SeaSpine Announced Limited Commercial Launch of Skipjack Expandable Interbody Device
SeaSpine Holdings, a spinoff of Integra LifeSciences focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders, announced the limited commercial launch (alpha launch) and completion of initial cases for its Skipjack Expandable Interbody Device (IBD). Based on the intellectual property acquired as part of the NLT Spine purchase in August 2016 for an upfront payment of $1.0 million, the Skipjack IBD provides surgeons the ability to place smaller implants that expand within the interbody space, potentially enabling smaller incisions and more limited nerve retraction without sacrificing the advantages of larger implants. This in-situ expansion is intended to reduce tissue disruption, minimize endplate damage and, thereby, improve patient outcomes. The implants are designed to provide continuous in-situ expansion in either height or lordosis for a tailored anatomical fit, provide up to 20 degrees of lordotic correction from a posterior approach, and are accompanied by integrated graft delivery instrumentation to post-pack the implant and surrounding disc space.
See more on the Skipjack IBD on Meddevicetracker.