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January 23, 2017
Becton, Dickinson Obtains Expanded Indication for PleurX
Becton, Dickinson and Company (BDX) announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the indication on its PleurX catheter system to include use in specific non-malignant recurrent pleural effusion etiologies, including congestive heart failure. This expansion, which was broadcasted at the 53rd Annual Society of Thoracic Surgeons (STS) Meeting, now offers patients the option to drain pleural fluid in the comfort of their own homes or for professional use in an outpatient procedural setting, ultimately minimizing both the frequency and duration of hospital visits.
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January 24, 2017
InVivo Announces Patient Progress in IDE INSPIRE Clinical Study
InVivo announced that the patient who enrolled in the company’s IDE INSPIRE clinical study of the Neuro-Spinal Scaffold in December 2016 has improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury in the time between discharge and month-month evaluation. This news marks the sixth out of eleven patients (54.5%) thus far to have reported an AIS grade improvement at follow-up, with two more patients anticipated to reach conversion by the six-month endpoint. With more patients yet to enroll in the current study, the company noted that the observed conversion rates insofar have exceeded expectations, and are therefore optimistic as they progress towards enrollment completion.
Medtronic Obtains CE Mark for Next Generation Device
Medtronic announced that it has obtained CE Mark approval for its next generation HawkOne Directional Atherectomy System. The new device, which recently received 510(k) clearance by the United States Food and Drug Administration (FDA) in October 2016, has been designed with a lower profile size (6F) than its predecessor, acting as an easier-to-use treatment option for patients with Peripheral Arterial Disease (PAD) both above and below the knee via a single device. In conjunction with the recent FDA 510(k) clearance, this CE Mark signifies an important step for Medtronic to maintain its position as a major player in the vascular disease market. Product launches of the device are currently scheduled to take place in both the United States and Europe early this year.
See more on the HawkOne Directional Atherectomy System on Meddevicetracker.
January 25, 2017
Positive Progress Forecasted for San Diego’s TearLab Corporation
TearLab Corporation announced that its 510(k) cleared TearLab Osmolarity System, intended for the diagnosis and management of Dry Eye Disease (DED), has obtained approval from the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) in Mexico. This approval provides TearLab with a clear path to begin selling their device in Mexico, which TearLab anticipates to bring to market in the country in the first half of 2017. To assist in the forthcoming launch, TearLab has entered into an exclusive distribution agreement with Cyan Medica, an organization with a successful history of marketing and distribution in the ophthalmic market in Mexico. Provided Cyan Medica’s touted expertise in the area, and given Mexico’s reported high demand for Dry Eye Disease care, one may confidently anticipate positive growth by TearLab in the near future.
See more on the TearLab Osmolarity System on Meddevicetracker.
Endologix Reinstated CE Mark
Endologix announced that it has received notice from its Notified Body in the European Union (EU) that the CE Mark for the AFX and AFX2 Endovascular AAA Systems has been reinstated, effective immediately. Previously, the company had announced a temporary hold on shipments of its AFX Endovascular AAA devices in the United States and Europe due to reports of Type III endoleaks with a prior generation of the device. With the hold, also came a suspension enacted by the EU on the device’s CE Mark approval. Since the time of the program hold, Endologix has been working to lift the temporary hold on its product in small waves, announcing the resumed shipments of all sizes of the system on January 17, 2017. With this reinstated CE Mark, and the fact that no patients were harmed by the device prior to or during suspension, Endologix can breathe a sigh of relief and remain confident for its anticipated approval decisions for the AFX2 in Japan, Asia Pacific, Argentina and Brazil, which are expected to occur by the end of 2017.
Lutonix 035 DCB PTA Catheter for Peripheral Arterial Disease (PAD)
Bard presented top-line results from its AV Access study at the Leipzig Interventional Course (LINC) on January 25, 2017. The study involved 285 patients who were randomized into a Lutonix DCB arm or a Standard PTA Catheter. The primary effectiveness endpoint is target lesion primary patency (TLPP) at 6 months. The primary safety endpoint is freedom from any serious adverse event(s) involving the AV access circuit through 30 days. Primary Safety at 240 days occurred in 48.8% (SE 4.4%) of patients treated with Lutonix DCB and 43.0% (SE 4.2%) of patients treated with a standard PTA (p=0.006). Target lesion pirmary patency at 240 days for Lutonix was 61.6% (SE 4.3%) and 49.4% (SE 4.3%) of standard PTA patients [Difference = 12.2% (SE 6.1%), p=0.020]. The number of interventions required to maintain TLP at 240 days in the Lutonix patients were 66 and 94 interventions in the standard PTA group (p=0.024). These results demonstrated safety outcomes for the Lutonix DCB were non-inferior to PTA and 29.8% fewer interventions were required to maintain in TLP in the DCB arm.
See more information on Lutonix 035 DCB PTA Catheter on Meddevicetracker.
January 26, 2017
Viveve Progresses Forward in the United States
After receiving 510(k) clearance from the United States Food and Drug Administration (FDA) in October 2016, Viveve Medical officially announced the United States launch of its proprietary radiofrequency device, GENEVEVE, for use in general surgical procedures for electrocoagulation and hemostasis. Previously, GENEVEVE had been granted approvals in Europe and Japan, as well as several emerging markets such as Brazil, Columbia, Costa Rica, and United Arab Emirates, for use in non-surgical treatments of vaginal laxity. Inasmuch, although this recent approval and product launch represent an important step forward for Viveve Medical, the company continues to await authorization from the FDA to initiate its Pivotal VIVEVE II clinical study, intended to evaluate GENEVEVE in the treatment of vaginal tissue to improve sexual function in women. Provided the FDA authorizes the De Novo 510(k) submitted by Viveve in September 2016, the trial can be expected to initiate by the end of the first quarter. Findings would be used to in support of approval for an expanded indication of GENEVEVE in the United States, which Viveve already anticipates to happen by the end of 2017. This approval, if granted, would undoubtedly enable Viveve to solidify its spot as a key player in world-wide market of women’s health.
See more on GENEVEVE on Meddevicetracker.
Leadless Pacemakers to be Covered by Medicare/Medicaid
Medtronic announced that the U.S. Centers for Medicare and Medicaid Services (CMS) will now cover leadless pacemakers as outlined in the agency’s final National Coverage Determination (NCD). The decision allows for coverage when procedures are performed in FDA-approved studies of leadless pacemakers and prospective longitudinal studies approved by the CMS. This determination will allow broad patient access to this minimally invasive pacemaker technology as Medtronic works closely with CMS to ensure access to their Micra TPS pacemaker. Medtronic received FDA approval for the Micra TPS, which is less than one-tenth the size of a traditional pacemaker, in April 2016 and is currently the only leadless pacemaker approved for use in the U.S.
Meddevicetracker: medical device intelligence and forecasts
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