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March 27, 2017
Bovie Medical’s J-Plasma Receives 510(k) Clearance
Bovie Medical announced it received 510(k) clearance from the FDA for a new J-Plasma generator and handpiece that incorporate Cool-Coag technology in early March. Cool-Coag combines the benefits of J-Plasma, namely increased precision with minimal thermal spread, with standard monopolar coagulation and helium spray coagulation capabilities, all in one handpiece. This allows the surgeon to benefit from using a single device that offers the greater control of tissue effect that J-Plasma delivers, while being able to switch to a monopolar or helium spray coagulation mode with just the push of a button.
The company has scheduled a commercial launch for the J-Plasma in the second half of 2017.
See more information the J-Plasma on Meddevicetracker.
NeoTract Announces Five-Year Follow-Up Data for UroLife System
NeoTract announced five-year follow-up data from the pivotal, randomized L.I.F.T. IDE study, which evaluated the safety and effectiveness of the company’s novel UroLift System in patients with symptomatic benign prostatic hyperplasia (BPH). The long-term data presented at the 18th annual European Urological Association (EUA) meeting reinforces the UroLift System treatment becoming the standard of care first-line treatment for men unhappy with BPH medications.
Results demonstrated that the UroLift System provides a highly tolerable, minimally invasive procedural experience; rapid reduction of symptoms after the procedure while preserving sexual function; sustained effect, with IPSS (International Prostate Symptom Score) and Qmax (peak urinary flow rate) remaining 36% and 44% improved from baseline, respectively; Quality of life (QoL) score improvement of 50% over five years; a durable treatment with a low retreatment rate of 2-3% per year.
See more information the UroLift System on Meddevicetracker.
March 28, 2017
Integra LifeSciences Launches Cadence Total Ankle System
Integra LifeSciences announced the full commercial availability of its Cadence Total Ankle System. More than 200 Cadence total ankle procedures have been performed in seven countries since initial clinical use more than a year ago. The Cadence System features side-specific, anatomical tibial and talar components, and bearing insert components manufactured from highly crosslinked ultra-high molecular weight polyethylene (HXL UHMWPE) for improved wear. The Cadence System was previously available in a limited market release. The Cadence system is now fully available in the United States, Canada, and select European countries.
See more information the Cadence Total Ankle System on Meddevicetracker.
Roche Launches cobas HPV for Cervical Cancer in Europe
Roche announced the launch of the cobas HPV on the cobas 6800/8800 System for cervical cancer screening in markets accepting the CE Mark. This HPV DNA assay adds to the growing CE-IVD menu on the cobas 6800/8800 Systems, and gives laboratories the ability to run HPV DNA testing with other previously released cobas assays.
As demonstrated by the prospective clinical study “ATHENA” comparing screening strategies using cobas HPV test on the cobas 4800 System, screening with the HPV test detects more high-grade disease than a Pap test alone.
See more information on the cobas HPV Test on Meddevicetracker.
March 29, 2017
NuVasive Receives FDA Clearance for Multiple Level Cervical Implant
NuVasive announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the CoRoent Small Interbody System, indicated for intervertebral body fusion at multiple contiguous levels in the cervical spine. This marks the first U.S. clearance for a cervical cage to be used at up to four contiguous levels.
See more information on the CoRoent System on Meddevicetracker.
QIAGEN Launches JAK2 Test for Certain Type of Leukemia
QIAGEN announced the U.S. launch of its ipsogen JAK2 RGQ PCR Kit (ipsogen JAK2 assay), which was cleared by the U.S. Food and Drug Administration as a qualitative in vitro diagnostic test for the detection of the JAK2 V617F/G1849T allele in genomic DNA extracted from EDTA whole blood.
QIAGEN’s ipsogen JAK2 assay is the first and only FDA-cleared kit for the JAK2 V617F mutation, which is found in nearly all patients with Polycythemia Vera and belongs to a group of blood cancers known as myeloproliferative neoplasms (MPNs) that affect about 300,000 patients in the United States.
See more information on the ipsogen JAK2 RCG PCR Kit on Meddevicetracker.
March 30, 2017
ASPiRA LABs Announces In-Network Agreement for OVA1
ASPiRA LABs, a Vermillion company, announced it has signed an in-network, contracted agreement with TriCare
South for ASPiRA’s U.S. FDA cleared and Centers for Medicare and Medicaid Services (CMS) covered OVA1 ovarian cancer risk assessment test. TriCare South serves about 2.5 million beneficiaries in the states of Alabama, Arkansas, Florida, Georgia, Louisiana, Mississippi, Oklahoma, South Carolina, Tennessee, Texas (excluding El Paso) and Fort Campbell, Kentucky.
See more information on the OVA1 on Meddevicetracker.
Cardiovascular Systems Receives US and Japan Approval for Micro Crown
Cardiovascular Systems announced that that Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved the Diamondback 360 Coronary OAS Micro Crown as a frontline treatment for de novo severely calcified lesions and to facilitate access to the arteries for percutaneous coronary interventions (PCI) thereafter.
Cardiovascular Systems also announced that the United States Food and Drug Administration (FDA) has approved the Diamondback 360 Coronary OAS Micro Crown system to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.
The OAS Micro Crown is the only device incorporating a diamond-coated tip to immediately engage and pilot through tight, severely calcified lesions that would otherwise be difficult to access, while also treating up to 4mm vessels with the same device.
See more information on the Diamondback 360 Coronary OAS Micro Crown on Meddevicetracker.
Boston Scientific to Acquire Symetis
Boston Scientific announced a definitive agreement to acquire Symetis, a privately-held Swiss structural heart company focused on minimally-invasive transcatheter aortic valve implantation (TAVI) devices, for $435 million in up-front cash.
The Symetis portfolio includes the ACURATE TA and ACURATE neo/TF valve systems for use in the treatment of high-risk patients suffering from severe and symptomatic aortic valve stenosis, which are sold in Europe and in other geographies outside of the United States. Symetis is also developing the ACURATE neo/AS next generation valve system, currently in a clinical trial intended to serve as the basis for a future CE mark application.
The acquisition is projected to close during the second quarter of 2017, subject to customary closing conditions.
See more information on Symetis on Meddevicetracker.
March 31, 2017
Endologix Announces Enrollment of First Patient in ELEVATE IDE Study
Endologix announced that the first patients were treated in the Expanding Patient Applicability with Polymer Sealing Ovation Alto Stent Graft (ELEVATE) IDE clinical study, the Company's pivotal clinical trial to evaluate the safety and effectiveness of the Ovation Alto Abdominal Stent Graft System for the repair of infrarenal abdominal aortic aneurysms (AAAs). The ELEVATE IDE clinical trial is approved to enroll 75 patients at up to 12 centers in the U.S.
See more information on the Ovation Alto System Meddevicetracker.
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