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May 15, 2017
Cancer Genetics announced that it has partnered with Ventana Medical Systems, a member of the Roche Group, to enable patient access to testing with Roche’s United States Food and Drug Administration (FDA) cleared VENTANA PD-L1 (SP263) Assay for the detection of urothelial carcinoma. Cancer Genetics noted that it recently participated in a new program launched by Ventana that provides pre-launch pathologist training and supports the lab in validating the assay to ensure early availability of testing. The agreement ensures that Cancer Genetics is one of the first laboratories in the United States with pathologists trained to use and interpret the test to inform patient treatment decisions. Prequalification of select laboratories ensures patients have immediate access to the urothelial carcinoma test across the United States.
The use of the VENTANA PD-L1 (SP263) Assay for PD-L1 expression testing in either tumor or immune cell membranes in urothelial carcinoma may be a useful tool to help determine the likelihood of responding to the anti-PD-L1 immuno-oncology (IO) therapy IMFINZI (durvalumab), developed by AstraZeneca, but is not required for use of IMFINZI.
See more on the VENTANA PD-L1 (SP263) Complementary Assay on Meddevicetracker.
Lombard Medical Announces ALTITUDE Trial Progress
Lombard Medical announced that it has enrolled and treated the first patient in the ALTITUDE (Altura Impact on the Treatment of Abdominal Aortic Aneurysms Using a Novel D-Stent EVAR Design) registry, which is expected to develop a more robust dataset of long-term outcomes with the Altura Endovascular Stent Graft. The device, which was CE mark approved in 2015 and subsequently launched in 2016, has been the subject of multiple small-sample clinical trials of between about 50 – 60 subjects per trial. This trial, however, expects a total enrollment of approximately 1,000 patients.
Interim data released insofar from a Phase I study suggests positive clinical outcomes at 30 days and 1 year, but more data is required to strengthen overall confidence from clinical communities in both Europe and the United States. To that end, although the Company announced it has halted commercial operations for the device in the United States, Lombard continues to discreetly prepare for an Investigational Device Exemption (IDE) submission and approval in the United States in the future. Therefore, the initiation of this trial is worth much more than appears on the face as the implications of trial success run deep – potentially forewarning a reinstatement of commercial operations of Altura in the United States in coming years.
See more on the Altura Endovascular Stent Graft on Meddevicetracker.
Shockwave Medical Obtains CE Mark for Coronary System
Shockwave Medical announced that it obtained CE Mark approval for its Coronary Lithoplasty System, indicated for the treatment of calcified plaque in conjunction with stenting in patients with coronary artery disease. This approval was heavily supported by the positive safety and performance data demonstrated by the DISRUPT CAD I, pre-market, prospective study conducted at clinical sites in Australia and Europe, which met all three primary endpoints of clinical success (95%), device success (98.3%) and facilitated stent delivery (100%) at 30 days in its 60 patient sample.
Now with 6-month updated results planned for presentation at the upcoming EuroPCR meeting, a question on many minds might be whether or not Shockwave will pursue expanded use clearance for the Lithoplasty System in the United States. For example, the device obtained CE Mark approval for use in peripheral artery disease in 2015, with a subsequent United States Food and Drug Administration (FDA) 510(k) clearance in 2016. It may be too soon to call, however if past regulatory history is any guide to gauge a Company’s path forward, an expanded clearance in the coming years, if not months, does not seem out of the question.
See more on the Lithoplasty System on Meddevicetracker.
FDA Grants Optune HUD Designation for Mesothelioma Treatment
Novocure Announced that the United States Food and Drug Administration (FDA) has granted the Company’s Optune TTFields delivery system Humanitarian Use Device (HUD) designation for the treatment of pleural mesothelioma. HUD designation covers devices that treat rare, orphan diseases or conditions. The HUD designation is the first step in obtaining a Humanitarian Device Exemption (HDE) for the treatment of pleural mesothelioma with TTFields. Novocure enrolled the last patient in its STELLAR trial, a Phase II pilot trial in pleural mesothelioma, in March 2017 and, with final data collection in 2018, is evaluating its options to file an HDE application with the STELLAR data. An approved HDE would allow Novocure to market TTFields in combination with standard of care chemotherapy as a treatment for pleural mesothelioma in the United States.
See more on Optune on Meddevicetracker.
May 16, 2017
Boston Scientific Closes Symetis Acquisition
Boston Scientific announced that it has closed its previously announced acquisition of Symetis SA, a privately-held Swill structural heart company specialized in minimally-invasive transcatheter aortic valve implantation (TAVI) devices. With the closing, Boston Scientific has successfully bolstered its portfolio of cardiovascular devices and will immediately begin selling the ACURATE TA and ACURATE neo/TF valve systems in Europe and in other geographies outside of the United States. Symetis will become part of the Boston Scientific Interventional Cardiology division.
See more on Boston Scientific on Meddevicetracker.
Boston Scientific Reports Positive Pivotal Trial Results
Boston Scientific announced positive, top-line results from the Pivotal REPRISE III clinical trial at the annual EuroPCR Scientific Program in Paris. Data demonstrated that the Company’s LOTUS Valve showed superiority over Medtronic’s CoreValve TAVI platform for the primary effectiveness endpoint and non-inferiority for the primary safety endpoint. This is significant because during the first quarter of 2017, Boston Scientific removed its LOTUS Valve from commercial and clinical use over safety concerns of a malfunction of the device. Specifically, the Company noted that the device could not be safely implanted due to the premature release of the pin connecting the valve to the delivery system. This forced the Company to schedule both the European re-release date and expected United States’ Premarket Approval (PMA) submission of the Valve to Q4 2017.
But with this data, which demonstrates LOTUS’ superiority to its United States Food and Drug Administration (FDA) cleared counterpart developed by Medtronic, Boston Scientific feels more bullish about successfully delivering on its announced catalysts and widening its share in the corresponding marketplace. Perhaps the wait will not be as long as was originally expected, as Boston seems to be back on track with LOTUS.
See more on the LOTUS Valve on Meddevicetracker.
May 17, 2017
Integra Launches New Extension to Regeneration Product
Integra LifeSciences announced it has launched in Europe its Integra Dermal Regeneration Template (IDRT) Single Layer “Thin,” indicated for dermal repair defects reconstruction in a “one-step” procedure. This product is the latest extension of the Company’s collagen technology, which has received an array of previous clearances in the United States and other major territories for the treatment of wounds, burns, and diabetic foot and other ulcers.
The Company noted that this European launch is significant however, because it is something they believe the European clinical community has been eager for. Being able to provide plastic and reconstructive surgeons with a single-use thinner matrix for dermal repair, without abandoning the aesthetic and functional benefits present in a two-stage procedure, falls directly in line with the Company’s wider goal of continually improving regenerative medicine on a global scale.
See more on Integra’s IDRT Single Layer “Thin” on Meddevicetracker.
Medtronic Reports Positive News on Use of App-Based Technology
Medtronic released positive usage data on its MyCareLink Smart app-based remote monitor, used by patients to monitor data emitted by their implanted pacemakers. Particularly, the Company found that 88.4% of patients of all ages who were prescribed this new technology used their smart devices to successfully activate their MyCareLink Smart mobile app, and 89.7% remained "adherent" by transmitting data to the Medtronic CareLink Network within 12 months, the minimum frequency recommended by the HRS and European Heart Rhythm Association expert consensus.
Arguably the most significant data revealed from this study was the fact that just over 89% of patients aged 71 and older were found to be using the app to transmit data, compared to the approximately 86 % of patients aged 18-50 years and 91% of those aged 51-70. From a socio-cultural perspective, many would assume that older patients would be less apt to utilize the web-based application in comparison to their younger counterparts who would be more familiar with such a technology. But that was not the case. In the grand scheme of things, these data demonstrate a noteworthy evolution taking place, wherein patients of all ages feel more inclined to exploit the technology available to them, and maximize their healthcare monitoring. Medtronic competitors would be prudent to acknowledge the paradigm shift taking place.
See more on the MyCareLink Smart app-based remote monitor on Meddevicetracker.
Endologix Provides Regulatory Update for Nellix
Endologix announced that the Company met with the United States Food and Drug Administration (FDA) regarding its Nellix Endovascular Aneurysm Sealing System (the Nellix EVAS System). Based upon that meeting and further internal analysis, the Company has determined that it will seek U.S. approval of the Nellix EVAS System by conducting a confirmatory clinical study with the previously updated Instructions for Use (IFU) and the Gen2 device design, which is currently sold in Europe and other international markets. The Company will collaborate with the FDA over the coming months on the confirmatory clinical study protocol and anticipates beginning patient enrollment in the fourth quarter of this year with PMA approval estimated to occur in 2020. At the break of this rather disappointing news, shares of Endologix stock have dropped approximately 37%.
See more on Nellix on Meddevicetracker.
May 18, 2017
Avita Medical released positive data from two pivotal trials of the Company’s ReCell device for the treatment of severe burns. In a 30-patient trial designed to evaluate the superiority of ReCell in treating severe burns when compared to conventional skin grafting, the study met both of the co-primary effectiveness endpoints. Similarly, in a supportive study approved under the same Investigational Device Exemption (IDE) that included 101 burn patients, ReCell’s superiority and non-inferiority was positively demonstrated through the defined safety and efficacy endpoints.
In combination, Avita has made it clear the Company feels bullish about its regulatory timeline for the product. Particularly, geared with the extra safety and efficacy data to support the encouraging data from its pivotal clinical trial, the Company noted that it is ready to file a premarket approval (PMA) application with the United States Food and Drug Administration in the middle of 2017, and anticipates an approval and subsequent product launch by the second quarter of 2018.
For a company that has struggled over the years to maintain a reputable stance in the regenerative medicine marketplace, these clinical findings and regulatory timeline could be critical to Avita’s future growth; especially when one considers the several alternative wound healing applications ReCell has potential for. With a seemingly positive pipeline in the works, competitors would be wise to keep an eye on Avita.
See more on ReCell on Meddevicetracker.
Thermo Fisher and Agios Pursue Companion Diagnostic Venture
Thermo Fisher announced that it has entered into an agreement with Agios Pharmaceuticals to develop and commercialize a next-generation sequencing (NGS) oncology companion diagnostic (CDx) for ivosidenib (AG-120) to identify isocitrate dehydrogenase 1 (IDH1) mutations in cholangiocarcinoma patients. Thermo Fisher is currently Agios' technology partner in the Phase III ClarIDHy trial, providing NGS for all tumor samples as inclusion criteria for enrollment. Upon validation of the CDx, Thermo Fisher will submit a supplemental premarket approval (PMA) application to expand clinical claims for its multi-therapy NGS test that is currently awaiting approval by the U.S. Food and Drug Administration.
Under the terms of the agreement, Thermo Fisher will retain the rights to commercialize the test globally and will lead all necessary filings to seek clearance from regional regulatory agencies. Use of an approved multi-gene CDx to simultaneously screen patients for targeted therapies is a shift away from the conventional testing method of running several, single-biomarker analyses in sequence to identify tumor profiles. Thermo Fisher aims to change the paradigm from one test for one drug, to one test for multiple therapies.
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