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September 11, 2017

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Gecko Receives CE Mark Approval for SETALUM Sealant

Gecko Biomedical announced that it received CE Mark approval for its first product, SETALUM Sealant, a polymer for tissue reconstruction, targeting vascular reconstruction as an initial indication. The polymer is part of the Company’s biopolymer platform, comprised of fully synthetic bioinspired light-activated tissue adhesives with strong adhesive and sealing capacity. The platform has the potential of being integrated in novel applications in other fields of tissue reconstruction such as guided tissue repair, and the field of localized drug delivery. The SETALUM Sealant is a biocompatible, bioresorbable and on-demand activated sealant usable in wet and dynamic environments as an add-on to sutures during vascular surgery. The polymer is applied to tissue in-situ and activated using a proprietary light activation pen.



The grant of the CE Mark for the vascular sealant is the first regulatory validation of the safety and performance of Gecko Biomedical’s scalable polymer platform. The sealant was evaluated clinically in the BlueSeal trial, a prospective, single-arm and multi-center clinical investigation performed at four French university hospitals and undertaken in patients necessitating a carotid endarterectomy. Performance of the sealant was evaluated by the percentage of immediate hemostasis following clamp removal. Based on a sequential Bayesian design, the recruitment was stopped at 22 enrolled patients given the fulfilled performance criteria and the optimal safety profile of the sealant. Immediate hemostasis was achieved in 85% of patients and all recorded adverse events were found to be representative of those commonly occurring in patients necessitating vascular reconstruction with none considered as related to the sealant.



See more on the SETALUM on Meddevicetracker.



DePuy Synthes Launches TRUMATCH CMF Titanium 3D-Implants in United States

DePuy Synthes announced the U.S. launch of TRUMATCH CMF Titanium 3D-Printed Implants for use in craniomacillofacial (CMF) reconstruction. The TRUMATCH implants are designed based on a Computer Tomography (CT) scan of a patient’s skull. The patient-specific implants can be designed to fit voids in the cranial and craniofacial skeleton. Depending on the size (length, width and height) of the implant required, DePuy Synthes may design a single or multi-piece implant. Multi-piece implants allow the surgeon greater flexibility when treating larger defects. The implants are made of two biocompatible materials: PEEK Optima-LT (polyetheretherketone) or Commercially Pure (CP) titanium. In August 2017, the U.S. Food and Drug Administration granted DePuy 510(k) clearance for TRUMATCH, indicated for bone repositioning, fixation and reconstruction of the maxillofacial skeleton, midface, mandible and chin in adolescents (greater than 12 to 21 years of age) and adults, including orthognathic surgery, reconstructive mandible and maxillofacial surgery, and mandible and maxillofacial trauma surgery.



With the addition of these personalized implants, DePuy Synthes is now able to offer TRUMATCH Orthognathics, a personalized total solution for orthognathic surgery, also known as corrective jaw surgery, as well as Titanium 3D-Printed Implants for other facial reconstruction applications. The new products will be distributed by Materialise through an exclusive agreement that was announced in July 2016. The distribution agreement allows Materialise to offer TRUMATCH titanium 3D-printed implants for use in facial and skull disorders in Europe (except France) and Australia. DePuy Synthes has worked with Materialise in the field of personalized solutions for craniofacial surgery since 2010, providing surgeons with computer-aided surgical planning and 3D-printed, personalized surgical guides. DePuy Synthes will begin marketing TRUMATCH Titanium 3D-Printed Implants in mid-September.



See more on the TRUMATCH CMF Titanium 3D-Implants on Meddevicetracker.



Medtronic Initiates Voluntary Recall of Select Infusion Sets Used With Medtronic Insulin Pumps

Medtronic announced that it has started to inform patients worldwide of a voluntary recall of specific lots of MiniMed Infusion Sets used with all models of Medtronic insulin pumps. The recall is related to a certain discontinued component in these infusion sets and does not include insulin pumps or glucose sensors. The company determined, through recent field reports from patients and root cause analysis, that a component, the vent membrane, in the recalled infusion sets may be susceptible to being blocked by fluid during the process of priming/fill-tubing. This situation can lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycemia. Currently manufactured infusion sets, available to patients since April 2017, include a design update of this component which the company believes reduces the risk of insulin over-delivery after an infusion set change. The company will work with patients to ensure recalled infusion sets with the discontinued component are returned and replaced with new infusion sets containing the updated component at no cost.



The MiniMed Infusion Sets portfolio consists of four different infusion sets: MiniMed Quick-Set, MiniMed Silhouette, MiniMed Sure-T, and MiniMed Mio. These sets, which are intended to be used with the MiniMed Paradigm Insulin Subcutaneous Infusion Pumps for continuous subcutaneous insulin infusion by patients or caregivers in the home environment, received 510(k) Clearance from the U.S. Food and Drug Administration in August 2016.



See more on the MiniMed Infusion Sets on Meddevicetracker.




September 12, 2017

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Atricure Launches AtriClip PRO V LAA Exclusion System in United States

AtriCure announced that its AtriClip PRO V Left Atrial Appendage (LAA) Exclusion System is now available to all customers in the United States. The Exclusion System consists of a self-closing, implantable clip preloaded on a single-use clip applier. When closed, the Clip applies uniform pressure over the length of the Clip to ensure consistent, reproducible, and secure occlusion of the left atrial appendage (LAA). The Clip Applier is a disposable device with a handle, shaft, suture anchors, and deployment loop which contains the clip. AtriCure first received 510(k) Clearance from the U.S. Food and Drug Administration for the AtriClip LAA Exclusion System in June 2010, indicated for the occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures. Outside of the U.S., the Company has received CE mark approvals for the AtriClip LAA Exclusion System in October 2009 and for the AtriClip PRO2 in June 2016. The AtriClip Standard and the AtriClip Pro devices received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW). Lastly, AtriClip received regulatory approval in China in January 2017.



The new PRO V device offers an open-ended design combined with a tip-first closure mechanism to enable easier navigation and placement when operating in minimally-invasive surgery (MIS) environments. In March 2016, the Company received 510(k) clearance for the AtriClip LAA Exclusion System with Gillinov-Cosgrove Clip, which includes the PRO V and PRO2 devices. After being cleared by the FDA, AtriCure introduced the device to a limited number of customers in the U.S. The AtriClip PRO V has identical forces and pressure specifications to the closed-end design of the other AtriClip devices, such as the AtriClip FLEX and the AtriClip PRO2. The AtriClip PRO V is also compatible with 12mm ports, making it an ideal choice for minimally invasive approaches. In addition, the design allows for the AtriClip PRO V to be repositioned multiple times before deployment to ensure ideal placement at the base of the appendage.



See more on the AtriClip LAA Exclusion System on Meddevicetracker.



Novate Announces 12-Month Data for SENTRY Vena Cava Filter at VIVA17


Clinical trial results for Novate’s SENTRY device were presented by Principal Investigator, Michael Dake MD of Stanford University in California at the 15th Annual Conference on Vascular Interventional Advances (VIVA17), which has been taking place in Las Vegas.


SENTRY is a prospective, single-arm, multi-centre registry trial in which the safety and effectiveness of the world’s first bioconvertible inferior vena cava (IVC) filter was studied. The SENTRY is a new generation of IVC filter designed to provide protection from pulmonary embolism (PE) for the period of transient risk and then bioconvert to leave a patent, unobstructed IVC lumen, obviating the need to retrieve and addressing the typical filter-related complications of existing IVC filters.



129 patients requiring temporary protection against PE were enrolled across 23 sites in the US, Europe and Chile. The rate of new symptomatic PE through 12 months was 0% (0/129).  There were no instances of filter tilting, migration, embolization, fracture, or IVC perforation through 12 months, and there were no filter-related deaths.  The rate of successful filter bioconversion was 95.7% (110/115) at 6 months and 96.4% (106/110) at 12 months. This is higher than the majority of published IVC filter retrieval rates.  The SENTRY IVC filter received U.S. FDA 510(k) clearance in February 2017.



See more on the Sentry IVC Filter on Meddevicetracker.



Senseonics Announces CE Mark for Eversense XL CGM


Senseonics announced it has received CE Mark approval for the Eversense XL Continuous Glucose Monitoring (CGM) System. The Eversense XL System includes an extended life implanted glucose sensor lasting up to 180 days, a removable discreet smart transmitter, and a mobile app for display of real-time glucose readings. According to the Company, the Eversense XL System provides the world’s longest-lasting sensor, compared to the frequent weekly sensor insertions required by other CGM systems.

CE Mark indicates that the product design conforms to the requirements of the Active Implantable Medical Device Directive (AIMDD 90/385/EEC). Eversense XL is indicated for continually measuring interstitial fluid glucose levels in adults and to be used as an adjunctive device to complement information obtained from standard home blood glucose meters.



See more on Eversense on Meddevicetracker.



Neovasc Provides Update on Tiara Valve


Neovasc provided an update on the study progress and clinical performance of the Tiara valve, a self-expanding mitral bioprosthesis for transcatheter implantation in patients with Mitral Regurgitation (MR).

To date, 34 patients have been treated with the Tiara valve at ten different medical centers across the United States, Canada, Germany, Italy, Belgium, Switzerland and Israel. The technical success rate in these implantations is 31/34 or 91.1%. In these technically successful implantations, paravalvular leak levels were reported as mild, trace or absent in 100% of these cases. All cause, 30-day mortality in the 33 patients who have reached 30 days post implant with Tiara is 12.1% (4/33). The remaining patient treated within the last 30 days is recovering well. To date, the longest surviving patient has passed 3.5 years post implant.

Implantations of the Tiara are being performed under 3 parallel clinical/investigational programs:


  • a European pivotal CE Mark trial, TIARA-II
  • an FDA Early Feasibility trial, TIARA-I
  • compassionate use/special access treatment


To date, the Company has received regulatory approval in Italy, Germany and the UK to conduct the TIARA-II study at 10 centers (5 in Italy, 3 in Germany and 2 in the UK). The TIARA-II study, which is the primary focus of the Tiara program, is a 115 patient, non-randomized, prospective clinical study evaluating Tiara's safety and performance. It is expected that data from this study will be used to file for CE Mark approval.


In addition, the Company has recruited two new U.S. centers to participate in its TIARA-I study, and is actively recruiting in 4 centers in the U.S., 1 center in Belgium, and 3 centers in Canada. TIARA-I is an international, multicenter early feasibility study being conducted to assess the safety and performance of the Tiara mitral valve system and implantation procedure in high-risk surgical patients suffering from severe mitral regurgitation.



See more on the Tiara on Meddevicetracker.




September 13, 2017

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Researchers Announce Positive Top-Line Data on FreeStyle Libre SELFY Trial at EASD

Data from the SELFY study were presented during a scientific session in an abstract titled "FreeStyle Libre use for self-management of diabetes in children and adolescents" at the 2017 European Association for the Study of Diabetes (EASD) annual meeting. Abbott’s FreeStyle Libre is a continuous glucose monitoring device applied to patients by healthcare professionals in a clinic setting. A healthcare professional applies a small, round sensor on the back of the patient's upper arm. The water-resistant and disposable sensor is held in place with a self-adhesive pad and remains on the back of the arm for up to 14 days, requiring no patient interaction with the device or the need for the patient to draw blood via a fingerstick to calibrate the sensor.



This SELFY study aimed to evaluate the use of FreeStyle Libre as a replacement for self-monitoring of blood glucose (SMBG) in young people (4-17 years) with type I diabetes (T1D). 76 patients were enrolled in a 10 week single arm European study (UK, Ireland and Germany) and underwent two weeks baseline masked (blinded) wear, followed by 8 weeks open use according to labeling. The primary endpoint was non-inferiority of glycaemic control assessed using time in range. Time in range (3.9-10.0 mmol/L) significantly improved vs. baseline by 1.0±2.8 hours/day (mean±SD), p=0.0056. HbA1c significantly improved vs. baseline, -4.4±5.9 mmol/mol (-0.4±0.6%), p<0.0001. Time in hyperglycaemia (>10.0 mmol/L) significantly reduced vs. baseline by -1.2±3.3 hours/day, p=0.0038, while no statistically significant changes were observed for time in hypoglycaemia (time <3.9 mmol/L, baseline, 1.1±1.2 hours/day). Total daily insulin dose increased by 1.4±3.5 units (p=0.0010). Scan frequency of FreeStyle Libre was on average 12.9 times daily, whereas SMBG tests dropped from a median of 8.0 (baseline) to 1.0 per day during open use. Diabetes Treatment Satisfaction Questionnaire showed increased overall treatment satisfaction for parents (n=70), 21.7±6.6 (mean change score±SD), p<0.0001 and teens (13+years) (n=23), 18.7±5.6, p<0.0001. Occurrences of mild or moderate sensor insertion site symptoms were as expected with device use. Three device-related adverse events (AEs), all mild (dry collection, dry flaky skin and redness) were reported by 3 patients. There were no device-related serious AEs. Researchers concluded that use of FreeStyle Libre as a replacement for SMBG by children and adolescents with T1D improved glycaemic control, reduced HbA1c with no change in hypoglycaemia and enhanced treatment satisfaction.



FreeStyle Libre has received CE Mark approval in September 2014 for people with diabetes and in February 2016 for children and teens with diabetes aged 4-17 years old. The device was approved by the U.S. Food and Drug Administration under a Premarket Approval (PMA) application in September 2016. Additionally, the device received regulatory approval in Australia in February 2016 and most recently in Canada in June 2017.



See more on the FreeStyle Libre on Meddevicetracker.



GI Dynamics Presents Data for EndoBarrier at EASD


Data from a UK, multicentre, randomised controlled trial investigating the interaction of Endobarrier therapy, a 60cm endoscopically implanted proximal intestinal liner, with glucagon-like peptide-1 drug therapy was presented during a scientific session in an abstract titled "Efficacy, safety, tolerability and sustainability outcomes of endoscopic proximal intestinal exclusion with EndoBarrier: 1st UK NHS EndoBarrier service for diabesity" at the 2017 European Association for the Study of Diabetes (EASD) annual meeting on September 13, 2017 in Lisbon, Portugal.


The aim was to evaluate whether acquired experience could translate into establishment of an effective and safe UK National Health Service (NHS) Endobarrier service for type II diabetes and obesity. The investigators initiated the 1st NHS Endobarrier service for patients with suboptimally controlled type II diabetes and obesity. The investigators primed patients to maintain improvements after, by instituting behaviour changes during, the period of up to 1 year of Endobarrier. The investigators established a secure online registry to monitor outcomes.


Since service initiation 65/153 (42%) referred have been accepted for treatment. 50 patients have had an Endobarrier implanted. 31 patients have had Endobarrier removed after treatment with the device. Mean±SD HbA1c fell by 24.7±24.1 mmol/mol from 81.4±23.4 to 56.7±11.6 mmol/mol (p<0.001), weight fell by 15.6±9.2 kg from 120.5±28.3 to 104.9±29.4 kg (p< 0.001) and systolic blood pressure from 137.3±13.7 to 124.9±15.8 mmHg (p<0.001). Serum alanine aminotransferase (ALT) reduced from 33.5±20.8 to 18.8±10.7U/L (p<0.001). In the 17 patients on insulin, median (IQR) total daily insulin dose reduced from 100 (40-130) to 30 (0-62) units (p=0.003) with 6/17 (35%) discontinuing insulin. Of 17 patients who have reached the 6 months post Endobarrier, 11/17 (65%) had sustained the substantial improvement achieved with Endobarrier. Of the 6 whose weight and/or HbA1c deteriorated after removal, 5/6 (83.3%) had big depression problems. 2/31 (6.5%) patients had early Endobarrier removal, one for gastrointestinal haemorrhage at 10 weeks having not complied with proton pump inhibitor therapy advice and one due to liver abscess at 7 months. Early removal led to resolution in both cases. All other patients achieved a full year of Endobarrier treatment. 93.8% patients would be extremely likely to recommend this service to friends and family.




This inaugural NHS service demonstrates Endobarrier to be highly effective in patients with refractory diabesity, with high patient satisfaction levels and an acceptable safety profile. After Endobarrier removal, 65% were able to sustain the benefits in HbA1c, weight, insulin dose and reduction in liver fat (as suggested by ALT reduction), and they reported considerable improvements in wellbeing, energy, and exercise ability. As endoscopy units are ubiquitous, our service could be readily disseminated, with the registry useful for on-going monitoring worldwide.



See more on EndoBarrier on Meddevicetracker.




Endologix Presents First-In-Human Data for Ovation Alto System at VIVA


Endologix presented first-in-human data from the First-In-Man Study in an abstract titled "First-in-Human Experience With Endovascular Aneurysm Repair Using the Ovation Alto Stent Graft" at the Vascular Interventional Advances Conference on September 13, 2017. The trial enrolled seven patients treated with the Ovation Alto stent graft at a single center (Auckland City Hospital in Auckland, New Zealand) from August 2016 to February 2017.



Ovation Alto was successfully delivered and deployed in all patients with 100% technical success. At 30-day follow-up, no type I or III endoleaks, stent graft migrations, abdominal aortic aneurysm (AAA) rupture, abdominal aortic aneurysm–related mortality, or secondary intervention were reported. 


Although limited to only seven patients, early experience with the Ovation Alto was promising and suggests the device may safely expand EVAR indications beyond that of other available devices. 




See more on the Ovation Alto System on Meddevicetracker.



September 14, 2017

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Ekso Bionics and GRS Collaborate to Study EksoGT in Skilled Nursing Facilities

Ekso Bionics and Genesis Rehab Services (GRS), a provider of physical, occupational, speech, and respiratory therapy, with a focus on the older adult population, announced their collaboration to study opportunities for incorporating EksoGT in skilled nursing facilities. Ekso is a wearable bionic suit which enables individuals with any amount of lower extremity weakness to stand up and walk over ground with a natural, full weight bearing, reciprocal gait. Walking is achieved by the user’s weight shifts to activate sensors in the device which initiate steps. Battery-powered motors drive the legs, replacing deficient neuromuscular function.



Through a learning collaboration between Genesis’ Layhill Center and Ekso, the team is working to learn more about post-acute rehabilitation settings to support better patient outcomes in skilled nursing facilities. The team aims to define the needs and challenges of the post-acute care industry, investigate tactics to efficiently deploy and scale an exoskeleton program, determine the clinical and economic benefits for a new standard of care, and quantify the economic case for adopting exoskeletons in rehabilitation.



The U.S. Food and Drug Administration (FDA) granted Ekso Bionics 510(k) clearance for the EksoGT in April 2017 for use in the treatment of individuals with hemiplegia due to stroke, individuals with spinal cord injuries at levels T4 to L5, and individuals with spinal cord injuries at levels of T3 to C7. The device, which is marketed as “SmartAssist” outside of the U.S., received CE mark approval in May 2012.



See more on the EksoGT on Meddevicetracker.



Long Term Outcomes Data for AMPLATZER Published in NEJM


Data from the RESPECT trial were published in an article titled "Long-Term Outcomes of Patent Foramen Ovale Closure or Medical Therapy after Stroke" in The New England Journal of Medicine on September 14, 2017.



In a multicenter, randomized, open-label trial, with blinded adjudication of end-point events, the investigators randomly assigned patients 18 to 60 years of age who had a patent foramen ovale (PFO) and had had a cryptogenic ischemic stroke to undergo closure of the PFO (PFO closure group) or to receive medical therapy alone (aspirin, warfarin, clopidogrel, or aspirin combined with extended-release dipyridamole; medical-therapy group).


The primary efficacy end point was a composite of recurrent nonfatal ischemic stroke, fatal ischemic stroke, or early death after randomization. The results of the analysis of the primary outcome from the original trial period have been reported previously; the current analysis of data from the extended follow-up period was considered to be exploratory.


The investigators enrolled 980 patients (mean age, 45.9 years) at 69 sites. Patients were followed for a median of 5.9 years. Treatment exposure in the two groups was unequal (3141 patient-years in the PFO closure group vs. 2669 patient-years in the medical-therapy group), owing to a higher dropout rate in the medical-therapy group. In the intention-to-treat population, recurrent ischemic stroke occurred in 18 patients in the PFO closure group and in 28 patients in the medical-therapy group, resulting in rates of 0.58 events per 100 patient-years and 1.07 events per 100 patient-years, respectively (hazard ratio with PFO closure vs. medical therapy, 0.55; 95% confidence interval [CI], 0.31 to 0.999; P=0.046 by the log-rank test). Recurrent ischemic stroke of undetermined cause occurred in 10 patients in the PFO closure group and in 23 patients in the medical-therapy group (hazard ratio, 0.38; 95% CI, 0.18 to 0.79; P=0.007). Venous thromboembolism (which comprised events of pulmonary embolism and deep-vein thrombosis) was more common in the PFO closure group than in the medical-therapy group.


Among adults who had had a cryptogenic ischemic stroke, closure of a PFO was associated with a lower rate of recurrent ischemic strokes than medical therapy alone during extended follow-up.




See more on the AMPLATZER PFO Occluder on Meddevicetracker.



K2M Announces Launch of EVEREST MI XT Spinal System


K2M announced the global launch of the EVEREST Minimally Invasive (MI) XTower instrumentation—an enhancement to the EVEREST MI XT Spinal System. In 2016, K2M launched the EVEREST MI XT Spinal System. The addition of the XTower enhances the EVEREST MI platform, providing a new surgical solution for treating complex deformities with the goal of achieving three-dimensional spinal balance. EVEREST MI XTower instrumentation encompasses the entire tab-to-screw assembly, providing rigid reinforcement of the EVEREST MI XT screw tabs. Streamlined instrumentation allows surgeons to use the XTower throughout the entirety of the procedure. A Support Tower Reducer provides 35 mm of reduction where necessary.


The addition of the EVEREST MI XTower to the EVEREST MI XT Spinal System provides surgeons with intraoperative customization of screw extension rigidity based on the intended clinical application. The increased screw extension strength provided by the XTower allows surgeons to treat a full spectrum of pathologies utilizing one system. The XTower provides the ability to customize the power of the reduction to perform complex procedures utilizing minimally invasive techniques.



See more on the EVEREST Deformity Spinal System on Meddevicetracker.



September 15, 2017

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Acarix Announces First Swedish Use of CADScor System


Acarix announced that the Cardiology Department at Skåne University Hospital in Lund will be the first Swedish Clinic using the CADScor System for non-invasive, non-radiation acoustic ruleout of Coronary Artery Disease (CAD). A recently presented study at the American College of Cardiology (ACC) 2017 Annual Scientific Meeting showed that CADScorSystem rules out CAD with 97% negative predictive value. The CADScor System combines acoustic detection of turbulent arterial flow and myocardial movement with advanced algorithms in a portable device to provide a patient specific CAD-score in less than 10 minutes.



See more on the Acarix CADScor System on Meddevicetracker.

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