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May 22, 2017

BONESUPPORT Announces FORTIFY Trial Progress

BONESUPPORT announced that the first patient has been enrolled by Dr. Ravi Karia at the University of Texas Health Science Center at San Antonio into the Company's pivotal Investigational Device Exemption (IDE) trial: A Prospective, Randomized, Multicenter Controlled Trial of CERAMENT G as Part of Surgical Repair of Open Diaphyseal Tibial Fractures(the FORTIFY trial).


The FORTIFY trial will assess CERAMENT G’s ability to improve on the standard-of-care management of patients with open fractures of the tibial diaphysis. The primary endpoints of the trial will include the absence of deep infection at the fracture site and the lack of secondary procedures intended to promote fracture union. The trial will also evaluate the safety of CERAMENT G in these patients. The trial will enroll up to 230 patients at up to 30 centers in the United States and Europe.


BONESUPPORT plans to use the data from the FORTIFY trial, assuming a positive outcome, to support a Premarket Approval (PMA) filing with the U.S. Food and Drug Administration. Once approved, the CERAMENT G would be the second product approved in the U.S. for BONESUPPORT, thus improving their market position in the bone graft and substitute space.


See more about CERAMENT G on Meddevicetracker.


OncoCyte Presents Positive Data at ATS

OncoCyte presented interim data on its diagnostic lung cancer test at the 2017 American Thoracic Society (ATS) International Conference. The abstract “Multi-Gene Classifier for the Diagnosis of Benign Versus Malignant Pulmonary Nodules” was presented on Monday, May 22, 2017. 


A total of 106 patients with either benign (n=50) or malignant (n=56) pulmonary nodules were analyzed. Malignant nodules included NSCLC (n=50), small cell (n=4), carcinoid (n=1), and lymphoma (n=1). Nodule size alone distinguished benign from malignant with high accuracy (AUC 0.94). Investigators constructed a classifier consisting of 8 genes that distinguished between benign and malignant lung nodules (AUC 0.87, 95%CI: 0.80, 0.93). When nodule size was added to the classifier, accuracy improved (AUC 0.99, 95%CI: 0.96, 1.00). Twenty-six of 40 patients with a nodule between 9 and 19mm were diagnosed with a malignant lesion (prevalence 65%). In this subgroup, the accuracy of nodule size to differentiate benign from malignant was limited (AUC 0.69). However, in this same subgroup, the 8-gene classifier had an AUC of 0.90, and an AUC of 0.96 when nodule size was included in the model.



While this classifier demonstrates feasibility for improved assessment of cancer risk for patients in whom clinical management is not straightforward (nodule size 9 to 19 mm), this classifier warrants further development and validation of its performance. OncoCyte believes the results reported significantly exceed levels necessary for a commercially successful test, which would be one of the first commercially available tests of its kind.



See more about the Lung Cancer Confirmatory Diagnostic on Meddevicetracker.



May 23, 2017

SonaCare Medical Announces Medicare C-Code Acceptance


SonaCare Medical announced the imminent reimbursement for HIFU prostate tissue ablation with a newly approved C-code.


As the first company to introduce and gain FDA authorization for sale of HIFU prostate tissue ablation in the United States inOctober of 2015, SonaCare Medical has worked extensively with its partners to obtain a reimbursement code for this minimally-invasive procedure. The Centers for Medicare and Medicaid Services (CMS) recently accepted the application for a HIFU C-code, which will go into effect on July 1st of this year.

See more about Sonablate on Meddevicetracker.


EnteroMedics Announces the Acquisition of the Gastric Vest System


EnteroMedics announced that it has acquired the Gastric Vest System (the "Gastric Vest" or "Vest"), through its acquisition of BarioSurg.


The Gastric Vest is an investigational, minimally-invasive, laparoscopically implanted medical device being studied for weight loss in morbidly obese patients. The device, which wraps around the stomach and emulates the effect of conventional weight loss surgery, enables gastric volume reduction without permanently changing patient anatomy. In a pilot study conducted outside the U.S., at 12 months, Vest patients demonstrated a mean percent excess weight loss (%EWL) of 85%, an average drop in HbA1c (Hemoglobin A1c) of 2.1 points, and an average waist circumference reduction of 38 centimeters, or approximately 15 inches.


The consideration paid by EnteroMedics for BarioSurg consists of 1.38 million unregistered shares of EnteroMedics common stock, 1.0 million unregistered shares of conditional convertible preferred stock (which will be convertible into 5.0 million unregistered shares of common stock upon the receipt of the required approval of EnteroMedics' stockholders under NASDAQ rules), and $2.0 million in cash. The shares of common stock issued in the acquisition represent 19.99% of EnteroMedics' outstanding common stock immediately prior to the acquisition. EnteroMedics expects to hold a special meeting of its stockholders to seek the required approval of the conversion of the conditional convertible preferred stock in the summer of 2017.


In connection with the acquisition, EnteroMedics has appointed Dr. Nihalani as Chief Technology Officer, EnteroMedics. This acquisition improves market penetration and positioning for EnteroMedics into the bariatric space. With potential European and U.S. approvals expected in the future, EnteroMedics could have the ability to drastically impact the current bariatric market.


See more about the Gastric Vest System and EnteroMedics on Meddevicetracker.



May 24, 2017

Acelity Launches PREVENA DUO Incision Management System


Acelity announced that the PREVENA DUO Incision Management System is now available to physicians in the United States. The PREVENA DUO System is the first single use negative pressure wound therapy (NPWT) system designed specifically for the simultaneous management of two closed surgical incisions, configured to help reduce post-operative complications in bilateral procedures, such as vascular harvesting, breast reconstruction and orthopedic trauma surgeries.



The PREVENA System, launched in 2010 , is the first disposable Negative Pressure system designed specifically for the management of closed surgical incisions. The system covers and protects the incision from external contamination, while negative pressure removes fluid and infectious material from the surgical incision.



The PREVENA DUO Platform provides the power and clinical benefits of PREVENA Therapy and is available in unique configurations. Each configuration includes two easy to use PEEL & PLACE Dressings for management of linear incisions up to 20cm in length. With this launch, PREVENA now offers the only incision management system capable of handling two incisions simultaneously, which should improve its current market position assuming penetration occurs as forecasted.



See more about the PREVENA Incision Management System on Meddevicetracker.



Gramercy Extremity Orthopedics Announces First Surgery

Gramercy Extremity Orthopedics announced the first surgery using the GEO Bone Screw and GEO CART systems. The first surgery was performed by Dr. Peter A. Blume, D.P.M., F.A.C.F.A.S. at Shoreline Surgery Center, Guilford, CT.



The GEO Bone Screw System offers a comprehensive array of low profile titanium screw lengths, diameters, thread lengths and fully threaded options. All GEO Bone Screws are double sterile packaged, self-drilling, self-tapping, reverse-cutting with variable length short and long threads and a hexalobe head to provide additional stability and torque transfer with less potential for head stripping. All instruments within the GEO Bone Screw system are also double sterile packaged in single use kits to ensure a new and sterilized instrument is used every surgery.



Gramercy Extremity Orthopedics hopes that with this successful surgery, more hospitals and surgeons adopt the GEO Bone Screw System as the primary treatment option during orthopedic surgeries.



See more about the GEO Bone Screw System on Meddevicetracker.



Medtronic Enrolls First Patient in the IN.PACT AV Access Study

Medtronic announced that the first patient has been enrolled in the IN.PACT AV Access Drug-Coated Balloon (DCB) study for use in patients with end-stage renal disease (ESRD). The U.S. Food and Drug Administration (FDA)approved the investigational device exemption (IDE) study to evaluate the safety and efficacy of IN.PACT AV Access DCB as a treatment for failing arteriovenous (AV) fistulas in ESRD patients.


The IDE study will evaluate the safety and efficacy of the IN.PACT AV Access DCB for up to two years at approximately 30 sites in the United States, Japan, and New Zealand. The study will aim to enroll 330 patients with a 1:1 randomization to either treatment with IN.PACT AV Access DCB or standard PTA. The primary efficacy endpoint is patency of dialysis fistulas through six months and the primary safety endpoint is serious adverse events through 30 days.



Medtronic hopes that positive clinical outcomes from this study will support an approval decision from the U.S. Food and Drug Administration for an expanded indication of the IN.PACT Admiral in the treatment of patients with end stage renal disease.


See more about the IN.PACT Admiral on Meddevicetracker.



May 25, 2017

CVR Medical Announces Update of Clinical Trials

CVR Medical announced an update of its clinical trials of the Carotid Stenotic Scan (CSS), being conducted through the Jefferson Clinical Research Institute at Thomas Jefferson University.



Tertiary clinical trials have now been underway for four months at multiple site locations across the Thomas Jefferson University footprint. CVR Medical is pleased with current trials progress, and all milestones and timeline projections are essentially moving ahead as planned. Additional devices have and are being introduced in an effort to increase data acquisition, while concurrently attempting to shorten the timeline to U.S. Food and Drug Administration (FDA) submission.



To date, almost 100 patients have been enrolled. Once the company finalizes the tertiary trials, CVR Medical will advance into pivotal trials for FDA submission in the near future. The commercialization of the CSS would be the first product available from CVR Medical, granting the Company penetration into the cardiovascular health market.



See more about the CVR Carotid Stenotic Scan on Meddevicetracker.

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