July 31, 2017
InVivo Therapeutics Announces Updates on the INSPIRE Study
InVivo Therapeutics provided an update on the progress of the company’s INSPIRE Study (InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury), which is designed to demonstrate the safety and probable benefit of the Neuro-Spinal Scaffold for the treatment of complete thoracic spinal cord injury (SCI). The primary endpoint of the study is defined as improvement in ASIA Impairment Scale (AIS) grade from baseline at the six-month visit. The study update includes:
A patient improved from complete AIS A SCI to motor incomplete AIS C SCI at the one-month visit.
A second patient improved from complete AIS A SCI to sensory incomplete AIS B SCI at the six-month visit.
Six of 11 patients (54.5 %) have had an AIS grade improvement at the six-month primary endpoint visit. The following table provides a summary of all patients in follow-up:
Of the seven conversions, four are AIS C conversions at this time, meaning these four patients have recovered both sensory and motor function. These conversions to AIS C have occurred as early as one month and as late as 24 months after Neuro-Spinal Scaffold. Having assessments of motor improvements occurring one or two years post-implantation is uncommon and may be indicative of prolonged neural repair.
One of the two patients who recently converted was implanted with the Neuro-Spinal Scaffold in January 2017 by Travis Dumont, M.D, Director of the Neurovascular Program and Principal Investigator at Banner – University Medical Center Tucson in Tucson, AZ. This patient initially converted from complete AIS A SCI to sensory incomplete AIS B SCI at two months but reverted back to AIS A at three months. Subsequently, at the six-month visit, the patient converted from AIS A to AIS B. This conversion to AIS B at six months will be included in the primary endpoint analysis of AIS improvements from baseline at the six-month visit.
The other patient who recently converted was implanted in June 2017 by Drs. Dan Altman, Nestor Tomycz, and Terrence Julien at Allegheny General Hospital in Pittsburgh, PA. The patient converted from complete AIS A SCI to motor incomplete AIS C SCI between the hospital discharge and one-month visits. At baseline, the patient was assessed to have a T6 neurological level of injury (NLI). In a large European registry, only 2.9% of patients with a T6-T9 NLI were reported to improve to AIS C or better by one month after injury. This is the second patient in the INSPIRE study to have reached AIS C motor incomplete classification at the one-month evaluation and the fourth patient in the INSPIRE study to have reached AIS C motor incomplete classification.
The most recent patient to enroll into the INSPIRE study, who was implanted in late June 2017, passed away suddenly at a rehabilitation facility following discharge from the hospital. The cause of death was deemed by the Principal Investigator at the site to be unrelated to the Neuro-Spinal Scaffold or implantation procedure. This represents the third death in INSPIRE to date, all of which have been deemed to be unrelated to the investigational product or implantation procedure by each respective site’s Principal Investigators.
The company has elected, based in part on discussions with the company’s independent Data Safety Monitoring Board, to implement a temporary halt to enrollment as it engages with the United States Food and Drug Administration (FDA) to determine whether any changes to patient enrollment criteria related to patients who may have a higher mortality risk or other study modifications are deemed necessary.
As a result of the temporary enrollment halt, the company anticipates completing INSPIRE enrollment in the first half of 2018 and submitting a Humanitarian Device Exemption (HDE) application in the second half of 2018.
See more about the Neuro-Spinal Scaffold on Meddevicetracker.
Medtronic Announces CE Mark of CoreValve Evolut Pro
Medtronic announced CE (Conformité Européenne) mark and European launch of the CoreValve Evolut PRO valve for the treatment of severe aortic stenosis for symptomatic patients who are at intermediate, high or extreme risk for open heart surgery. Clinical data for the Evolut PRO valve was recently unveiled at the American College of Cardiology (ACC) 66th Annual Scientific Session, and showed high survival, low rates of stroke, minimal paravalvular leak (PVL) and excellent hemodynamics.
The Evolut PRO device features a valve design with an outer wrap that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing performance. The biocompatible porcine pericardial tissue wrap, in addition to other design elements, is incorporated to address the occurrence of blood leaking through the sides of the valve.
The Evolut PRO Clinical Study (N=60) met its primary endpoint at 30 days with high rates of survival (98.3 percent) and low rates of disabling stroke (1.7 percent). The Evolut PRO valve also showed strong hemodynamic performance with large aortic valve areas (2.0 ± 0.5 cm2) and mean gradients in the single digits (6.4 ± 2.1 mm Hg) at 30 days. The majority of study subjects (72.4 percent) experienced no/trace PVL and no incidents of moderate or severe PVL were observed at 30 days. Additionally, improving on the already low rates seen in Evolut R clinical studies and real-world TVT and FORWARD registries, the rate of new pacemaker implantation was 10 percent.
Built on the platform of the recapturable CoreValve Evolut R System, the Evolut PRO valve includes a self-expanding nitinol frame with its supra-annular valve position that helps achieve excellent hemodynamic performance.
The Evolut PRO System is delivered through the EnVeo R Delivery Catheter System and is indicated for vessels down to 5.5 mm. The EnVeo R system features an InLine Sheath, which the Company touts makes it the lowest delivery platform currently on the market. It also provides a greater opportunity to treat patients with smaller vessels through the preferred transfemoral access route.
The 23 mm, 26 mm and 29 mm sizes of the Evolut PRO System received United States Food and Drug Administration (FDA) approval in March 2017 and are available for use in the United States.
See more about the CoreValve Evolut R on Meddevicetracker.
EDAP Announces 510(k) Filing for Ablatherm-Fusion Device
EDAP announced that the Company submitted a 510(k) application for its Ablatherm Fusion device, enabling a more precise method for targeting of diagnosed areas within the prostate. According to Marc Oczachowski, Chief Executive Officer of EDAP, this next generation model merges MRI, 3D biopsy maps, and ultrasound images by integrating the Company's proprietary software and fusion algorithm.
The U.S. Food and Drug Administration (FDA) has a standard approval timeline of 90 days for 510(k) premarket notification applications, therefore an approval decision could be expected before the end of 2017.
See more about the Ablatherm HIFU on Meddevicetracker.
August 1, 2017
AcelRx Reports Successful Outcome of Phase III IAP312 Study
AcelRx reported key results from the Phase III IAP312 study of ZALVISO (sufentanil sublingual tablet system), an investigational product candidate being developed for the management of moderate-to-severe acute pain in adult patients in a hospital setting.
The Company intends to submit these results, together with its earlier Phase III studies - IAP309, IAP310 and IAP311, which met safety and efficacy endpoints as part of its resubmission of a New Drug Application to the FDA by the end of 2017.
This study was designed to evaluate the effectiveness of changes made to the functionality and usability of the ZALVISO device, to evaluate the incidence of inadvertent dosing, and to take into account comments from the FDA on the study protocol.
Throughout the study in 320 enrolled patients, 2.2% of patients experienced a ZALVISO device error, which was statistically less than the 5% limit specified in the study objectives. Importantly, none of these device errors resulted in an over-dosing event. This 2.2% rate was lower (p < 0.001) than the 7.9% rate of device errors during patient use previously reported for the earlier version of the ZALVISO device in the Phase III IAP311 study.
In addition, as requested by FDA, the IAP312 study prospectively evaluated the number of inadvertently misplaced tablets which occurred during patient dosing. A small number of inadvertently misplaced tablets (less than 0.1% of total dispensed tablets) was observed in the original Phase III studies. However, the presence of inadvertently misplaced tablets had not been routinely assessed as part of the previous protocols. The ZALVISO System allows patients to self-administer a 15 mcg sufentanil sublingual tablet as often as once every 20 minutes as needed for pain control. Throughout the IAP312 study, patients self-administered a total of 7,293 sufentanil tablets. Per the updated ZALVISO training instructions electronically displayed on the hand-held device, 6 patients called the nurse when they failed to properly self-administer a single tablet to allow for proper retrieval and disposal of the tablet. Also, during inspection by the nurse, which occurred every two hours per protocol, a total of 7 misplaced tablets (<0.1% of total dispensed tablets) were discovered with 6 additional patients. No patient had a repeat incidence of an inadvertently misplaced tablet following re-training on the device.
Finally, in this study, 86%, 89% and 100% of patients at the 24, 48 and 72-hour time points, respectively, recorded "good" or "excellent" ratings on the patient global assessment (PGA) of the method of pain control, which measures a patient's satisfaction with their quality of analgesia. Healthcare professional global assessment (HPGA) of the method of pain control was similarly strong, with 91%, 95% and 100% of nurses rating ZALVISO as "good" or "excellent" over each respective 24-hour period.
ZALVISO was shown to be well tolerated by study participants, with nausea, hypotension and vomiting representing the most commonly reported adverse events. A total of 5 patients experienced serious adverse events, but all were considered unrelated to study drug by investigators.
See more about the ZALVISO PCA Device on Meddevicetracker. As this product is a drug-device combination product, the full regulatory and clinical history of Zalviso can be seen in the Biomedtracker profile.
LivaNova Receives CE Mark for VNS Therapy System
LivaNova announced its VNS Therapy Systems received CE Mark for expanded MRI labeling. The VNS Therapy implantable device is now indicated for epilepsy therapy and allows patients to have high-quality 1.5T and 3T MRI scans without the need for special equipment.
The CE Mark follows U.S. FDA approval for similar expanded MRI labeling, which LivaNova received in June 2017. The labeling change applies to the latest VNS Therapy technology, which includes AspireHC and AspireSR devices. Now, patients who have or desire to have VNS Therapy can more easily receive routine MRI scans.
The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizures (with or without secondary generalization) or generalized seizures that are refractory to seizure medications.
AspireSR (Seizure Response) features the Automatic Stimulation Mode which is intended for patients who experience cardiac rhythm increases that are associated with seizures.
See more about the Vagus Nerve Stimulation Therapy System on Meddevicetracker.
August 2, 2017
Medtronic Receives PMA Approval and CE Mark of Avalus
Medtronic announced it has U.S. Food and Drug Administration (FDA) approval and CE (Conformité Européenne) mark of its new Avalus pericardial aortic surgical valve for the treatment of aortic valve disease. The Premarket Approval (PMA) will allow Medtronic to commericialize Avalus throughout the United States, while the CE mark will allow commercialization throughout the European Economic Area.
The Avalus valve is a stented surgical aortic valve that is MRI-safe (without restrictions). The Avalus valve features several developments, including:
a supra-annular design for excellent hemodynamic performance, intended to limit central regurgitation.
Interior-mounted leaflet and frame design to enhance durability.
a low-profile valve design, streamlined valve holder and a single, one-cut release to facilitate ease of implantation.
The CE Mark of the Avalus valve is based on subsets of data from the PERIGON Pivotal Trial, a single arm, non-randomized, prospective study of more than 1,100 patients from approximately 40 clinical sites across Europe, Canada and the United States.
Top-line results from the PERIGON Trial demonstrated positive clinical outcomes at one year, with low linearized rates of thromboembolism (2.2 percent), endocarditis (1.0 percent), all paravalvular leaks (0.5 percent), all hemorrhages (3.7 percent) and major hemorrhages (2.7 percent). No thrombosis, hemolysis, severe paravalvular leaks or structural valve deterioration were observed at one year. At one year, all patients showed low rates of all-cause mortality (3.6 percent) and cardiac death (1.1 percent). Additionally, patients treated with the supra-annular design of the Avalus valve also experienced improved hemodynamic (blood flow) performance with mean aortic gradients improving from 42.3 mmHg at baseline to 12.6 mmHg at one year. Additionally, nearly three-fourths of patients improved one or two NYHA Functional Classes from baseline to one year across all valve sizes.
The Avalus valve will be commercially available later in 2017.
See more about the Avalus Aortic Valve on Meddevicetracker.
SI-BONE Announces Exclusive Positive Coverage with Blue Cross
SI-BONE announced that Health Care Service Corporation (HCSC) and its divisions of Blue Cross and Blue Shield (BCBS) in Illinois, Montana, New Mexico, Oklahoma, and Texas have updated their coverage policy for MIS SI joint fusion and maintained their exclusive positive coverage for the iFuse Implant System.
The updated policy, which took effect July 15th, 2017, includes additional iFuse Implant System clinical publications and specifically states that “use of minimally invasive or percutaneous SIJ fusion products other than titanium triangular implants/devices (e.g., iFuse Implant System) is considered experimental, investigational and/or unproven.” In other words, only the iFuse Implant System is considered a proven MIS SI joint fusion procedure and is covered by the policy.
Blue Cross and Blue Shield (BCBS) plans of Illinois, Montana, New Mexico, Oklahoma and Texas, under the umbrella of HCSC, is the largest customer-owned health insurer in the United States and the fourth largest commercial health insurer overall, covering approximately 15 million lives. The iFuse exclusive positive coverage policy, which originally became effective January 1, 2017, is based on the large body of published clinical evidence supporting the use of the patented triangular titanium iFuse Implants for SI joint fusion. The policy has been further strengthened with additional iFuse Implant publications demonstrating the safety and effectiveness of the iFuse Procedure.
The BCBS plans in Illinois, Montana, New Mexico, Oklahoma and Texas join SelectHealth in Utah and Geisinger in Pennsylvania as a growing number of commercial health plans to offer exclusive positive coverage for the iFuse Implant System.
See more about the iFuse Implant System on Meddevicetracker.
August 3, 2017
NeuroMetrix Announces DPNCheck Distribution Agreement
NeuroMetrix announced an agreement with Fukuda Denshi for DPNCheck distribution in Japan. DPNCheck is NeuroMetrix' rapid, accurate, and quantitative point-of-care test to detect diabetic peripheral neuropathy.
DPNCheck received regulatory clearance and was commercially launched in Japan during 2014. Distribution was handled by Omron Healthcare until the sale of its hospital medical products business to Fukuda Denshi in late 2016. This new distribution arrangement will complete the product transition to Fukuda Denshi.
NC-stat DPNCheck is a rapid, accurate and quantitative point-of-care test to detect diabetic peripheral neuropathy, or DPN, at an early stage allowing physicians to select appropriate treatment. DPN is the most common complication of diabetes, affecting over half of people with diabetes. DPN causes significant morbidity including pain, increased risk of falling in the elderly, and is the primary trigger for diabetic foot ulcers which may require lower extremity amputations.
See more about DPNCheck on Meddevicetracker.
Mainstay Medical’s ReActiv8-B Clinical Trial Passes Mid-Point
Mainstay Medical announced that over half the required number of implants in the ReActiv8 Clinical Trial have been performed. The trial is intended to gather data in support of an application for pre-market approval (PMA) from the US Food and Drug Administration (FDA).
69 subjects have been implanted with ReActiv8 in the trial. The trial design requires 128 subjects in the pivotal cohort to reach the 120-day endpoint before data are made available. An “interim look” for sample size re-estimation is planned when half the implanted subjects have data from the 120-day visit. The enrollment rate has been accelerating as the number of active sites has increased during 2017.
ReActiv8 is an implantable pulse generator with two leads placed bilaterally near the medial branch of the dorsal ramus nerve at the L3 vertebra to induce muscle contractions. Patients with the device undergo twice-daily 30 minute treatments in which an external wireless programmer controls and collects diagnostic information from the pulse generator.
See more about ReActiv8 on Meddevicetracker.
REVA Medical Announces Lapse of Boston’s Distribution Option
REVA Medical announced the expiration of Boston Scientific Corporation’s (BSC) exclusive right to negotiate for distribution of REVA’s coronary and peripheral bioresorbable scaffolds. BSC’s right to negotiate was available under a 2007 agreement that would have required BSC to pay REVA 50% of the average selling price on all product sales. Other commercial terms of a distribution agreement had not yet been negotiated.
BSC’s election window was triggered earlier this year when the Company delivered an extensive set of positive clinical data supporting the performance of Fantom, the Company’s drug-eluting coronary scaffold. With expiration of the distribution option, all aspects of the 2007 agreement are now concluded.
See more about the Fantom Bioresorbable Scaffold and the ReZolve Scaffold on Meddevicetracker.
August 4, 2017
Accuray Presents Radixact Results at AAPM Annual Meeting
Accuray announced that the first studies validating the benefits of the Radixact System were presented at the 59th Annual Meeting of the American Association of Physicists in Medicine (AAPM) held in Denver, Colorado, July 30 through August 3, 2017.
Research highlights include:
Faster Planning and Reduced Treatment Time
A study evaluated the performance of the Radixact System based on a comparison of treatment plans developed for this system and the TomoHDA System. Treatment plans were created using the VoLO Planning Solution for the TomoHDA technology, then recreated using the Accuray Precision Treatment Planning System (TPS) for the Radixact System. Developing plans using the Accuray Precision TPS was much faster, and the treatment beam-on time was reduced by up to 50% while maintaining the excellent plan quality. Researchers at the Miami Cancer Institute in Miami, Florida and Accuray Incorporated conducted the research.
Demonstrated Image Quality and Stability
The first clinical assessment of Radixact low-dose fan beam MVCT image guidance found there was no statistically significant difference in the noise, uniformity, and Hounsfield units (HU) stability over the three-month evaluation period, demonstrating the strength of the System's MVCT image quality and its potential value for dose calculation. Clinicians at the Miami Cancer Institute team conducted the research.
The Future of Radiation Therapy
See more about the Radixact System on Meddevicetracker.