May 22, 2017
FORTIFY Trial Progress
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).
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.
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
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.
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.
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
Medical Announces Medicare C-Code Acceptance
Medical announced the imminent reimbursement for HIFU prostate tissue ablation
with a newly approved C-code.
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
See more about Sonablate on Meddevicetracker.
EnteroMedics Announces the Acquisition
of the Gastric Vest System
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.
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
See more about the Gastric Vest System and EnteroMedics on Meddevicetracker.
May 24, 2017
Acelity Launches PREVENA
DUO Incision Management System
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.
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.
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
See more about the PREVENA Incision Management
System on Meddevicetracker.
Orthopedics Announces First Surgery
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.
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
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.
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
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.
more about the CVR Carotid Stenotic Scan on Meddevicetracker.