March 6, 2017
Venus MedTech Partnership in China and Key Asian Markets
Keystone Heart and Venus Medtech announced a partnership agreement to provide Venus Medtech's TAVR system in combination with Keystone Heart’s TriGuard Cerebral Embolic Protection Device. This agreement, covering China and key Asian markets, will allow physicians and patients in this region to benefit from Transcatheter Aortic Valve Replacement (TAVR) while simultaneously receiving complete three vessel embolic protection for the brain. The combination is unavailable in any other market or from any other company.
In recent research in leading US institutions, the NeuroTAVR study demonstrated that 94% of patients had new lesions in the brain following the TAVR procedure, 22.6% of patients had new neurologic impairment post TAVR, and 41% of patients had declining neurocognition at 30 days when compared to pre TAVR scores in US. China is an emerging market for TAVR procedures. Venus Medtech expects its TAVR device will be the first device approved by CFDA for marketing in China.
See more on TriGuard and Venus’s Transcatheter Heart Valve on Meddevicetracker.
Terumo and Toxikon Europe NV Announce a Strategic Partnership
Terumo Corporation and Toxikon Europe announced their strategic partnership by joining the expertise of both companies to service the pharmaceutical industry. Through this partnership, both companies substantially leverage their comprehensive knowledge and broad expertise in the developing, manufacturing, and testing of polymer container/closure systems for parenteral applications.
The partnership creates and offers a range of outstanding technical and scientific services, which enable Terumo to support their pharmaceutical and biopharmaceutical customers, and therefore facilitate a faster qualification and acceptance process for Terumo’s PLAJEX (Polymer-based prefillable syringe systems). The Toxikon Europe support relates to the extractables and leachables testing, toxicological assessments, impurity identifications and biocompatibility testing of PLAJEX and the associated components.
See more on PLAJEX on Meddevicetracker.
March 7, 2017
BTG announces CE Mark Certification for DC Bead LUMI, the First commercially available Radiopaque Drug-Eluting Bead
BTG announced it has received Class III CE Mark certification for DC Bead LUMI, the first commercially available radiopaque drug-eluting bead (DEB) in the European Union (EU) which can be loaded with doxorubicin or irinotecan for the local treatment of tumors in patients with hepatocellular carcinoma (HCC) and malignant colorectal cancer metastasized to the liver (mCRC). DC Bead LUMI provides real-time visible and lasting confirmation of bead location during transarterial chemoembolisation (TACE) procedures. DC Bead LUMI is a next-generation development of DC Bead.
See more on DC Bead on Meddevicetracker.
Avita Medical Announces Last Patient Visit in U.S. Pivotal Trial and Gives Regulatory Update
Avita Medical announced it has collected the last data set at the end of a 52-week follow-up period, which formally marks the completion of the pivotal U.S. Food and Drug Administration (FDA) trial evaluating Recell, which commenced in January 2015. The Company now has the necessary clinical data to conduct the analyses needed for a Premarket Approval (PMA) application.
In an update to the market now that PMA timings are more defined, Avita explained that dialog with the FDA via the Expedited Access Pathway (EAP) resulted in communication of updated guidance concerning preparation of materials for shelf-life stability testing, which has impacted the PMA submission timeline by one calendar quarter.
Shelf-life (stability) data for ReCell, in compliance with the additional FDA requirements, are scheduled to become available in June 2017, and the Company will file the PMA application soon after. The FDA decides on 90% of submissions requiring Advisory Committee input within 320 days of receipt of an accepted submission, meaning that an FDA decision can be anticipated during the second calendar quarter of 2018. Avita is engaged with the agency on the PMA submission via the EAP, and has ongoing dialogue surrounding its open Investigational Device Exemptions (IDEs) for Compassionate Use and Continued Access, under which the device can continue to be used during the pre-approval period.
See more on ReCell on Meddevicetracker.
U.S. FDA Approves Spectral’s Third PMA Module for its Toraymyxin Treatment of Endotoxemic Septic Shock
Spectral Medical announced that it has received approval of the third module of its rolling Premarket Approval (PMA) submission from the United States Food and Drug Administration (FDA) for Toraymyxin. The third PMA module details the device description and principles of operation and all manufacturing processes, including risk management and quality system integration. The company plans to file its fourth and final module containing clinical data early in the second quarter of 2017.
See more on Toraymyxin on Meddevicetracker.
March 8, 2017
Laboratoire CERBA Enters into Licensing Agreement with IntegraGen
IntegraGen and Laboratoire CERBA announced the signing of a licensing agreement allowing Laboratoire CERBA to develop and provide to prescribing clinicians a test based on IntegraGen’s proprietary miR-31-3p biomarker in France, Benelux, the Middle East and Africa. Laboratoire CERBA will develop this test to complement its existing portfolio and further enable physicians to proactively identify metastatic colorectal cancer patients who will have increased benefit from treatment with anti-EGFR therapy.
Financial details and terms of the agreement were not disclosed.
See more on the miR-31-3p Test on Meddevicetracker.
March 9, 2017
Medtronic Launches Below-The-Knee Clinical Study in Europe for Treatment of PAD Using New Drug-Coated Balloon Technology
Medtronic announced the launch of the IN.PACT BTK study to evaluate the effectiveness of using a drug-coated balloon (DCB) in patients with below-the-knee (BTK) peripheral arterial disease (PAD). This is an investigational device, which uses Medtronic's unique IN.PACT Admiral drug coating technology. This study will evaluate the IN.PACT 0.014 paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter.
The IN.PACT BTK study is a unique, prospective, randomized, multi-center study that will enroll approximately 60 patients at four sites in Europe. The study's primary endpoint is late lumen loss at nine months, an important angiographic measure of drug effectiveness, in patients who received treatment with the IN.PACT 0.014 DCB compared to standard PTA. The study also includes a wound care protocol, which provides additional safety controls and ensures patients will routinely undergo routine and standard monitoring by qualified wound care professionals.
See more on the IN.PACT 0.014 DCB on Meddevicetracker.
Autonomic Technologies Announces CE Mark for Expanded Indication for Disabling Migraine with Pulsante SPG Microstimulator System
Autonomic Technologies announced that it has received an expanded indication (CE mark) in Europe for the Pulsante SPG Microstimulator System to include pain relief for highly disabled migraine patients.
The Pulsante SPG Microstimulator System is the first implantable neurostimulation therapy to receive CE Mark for pain relief in both cluster headache and certain types of migraine. Specifically, the Pulsante SPG Microstimulator System is now also indicated for pain relief in migraine patients for whom standard of care treatment is inadequate or contraindicated, and who are disabled by attacks (with or without aura) with one or more of the following characteristics: predominately unilateral orbital or temporal pain, pain free periods between typical attacks, the presence of cranial autonomic symptoms. The expansion in indication was based on clinical data from a feasibility study.
See more on Pulsante SPG on Meddevicetracker.
March 10, 2017
MicroPort OrthoRecon Launches Medial-Pivot Knee Postmarket Clinical Follow-up Program
MicroPort officially launched the post-market clinical follow-up program of the EVOLUTION Medial-Pivot Knee in a kick-off meeting held in Xi'an from February 24 to February 25. The program was initiated by Professor Kunzheng Wang, Chairman-elect of Chinese Orthopaedic Association and Director of the Second Affiliated Hospital of Xi'an Jiaotong University, and will be carried out in 18 hospitals in the Chinese mainland and Hong Kong.
The post-market clinical follow-up program is designed to evaluate the postoperative recovery of Asian patients, who have been implanted with the EVOLUTION Pivotal Medial Knee system, to find out the best solutions for patient satisfaction and function recovery. The participating hospitals will assess the outcome of the Medial-Pivot Knee by gait analysis, muscle strength test and patient satisfaction rating.
See more on the EVOLUTION MP Knee System on Meddevicetracker.