7 medtech stories we missed this week: Sept. 29, 2017

medtech missed

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From EOI getting FDA clearance to Sanuwave’s new joint venture agreement, here are seven medtech stories we missed this week but thought were still worth mentioning.

1. EOI wins FDA nod for FLXfit15 expandable cage

EOI announced in a Sept. 28 press release that it has received FDA 510(k) clearance for its FLXfit 15. The clearance will help enhance the company’s FLXfir 3D expandable cage system and help expand the surgeon’s flexibility and capability by offering different length options.

2. ivWatch inks distribution deal with Terumo

ivWatch has recently signed a licensing and distribution agreement with Terumo to improve patient safety, according to a Sept. 21 press release. Terumo will become the exclusive distributor of the ivWatch Model 400 and ivWatch OEM board in Japan. ivWatch technology can be integrated with other patient monitoring systems, infusion pumps and other devices easily with the ivWatch OEM board. The agreement also allows Terumo to exclusively integrate ivWatch into existing and future Terumo products in Japan.

3. FDA clears Mortise Medical’s LigaMetrics suture anchor system

Mortise Medical announced in a Sept. 26 press release that it has received FDA 510(k) clearance for its LigaMetrics Suture Anchor System. The LigaMetrics Suture Anchor System is the first and only knotless suture anchor that allows for precise, measured tension control of the suture repair construct. The system is designed to connect to and lock suture tape that is attached to soft tissue or a conventional suture anchor.

4. Lombard Medical launches Aorfix delivery device in Japan

Lombard Medical has commercially launched its new delivery system for the Aorfix AAA system, according to a Sept. 26 press release. The new delivery system is marketed in Japan by Medico’s Hirata and is used to deliver Lombard’s Aorfix AAA stent graph.

5. FDA expands clearance for Cefaly migraine device

Cefaly announced in a Sept. 21 press release that the FDA has expanded its clearance for Cefaly Acute migraine treatment. The device is used for the acute treatment of migraines in patients 18 years or older. The Cefaly Acute allows migraine sufferers to use the device during a migraine attack which makes it more than a preventative measure.

6. Varian touts first use of Halcyon oncology system

Varian Medical System has announced that the first patient in the world has been treated using Varian’s Halcyon system, according to a Sept. 21 press release. The patient had head and neck cancer. The system is suited to offer advanced treatments for prostate, breast, head and neck and other forms of cancer.

7. Sanuwave inks JV deal with Brazil’s Mundimed

Sanuwave announced in a Sept. 28 press release that it has signed a joint venture agreement with Mundimed in Brazil. The agreement states that the companies will split profits in the wound care industry while using the dermaPACE technology. The net present value is expected to exceed $25M. Sanuwave will also receive an undisclosed amount of cash payments beginning Sept. 30 and the payments will continue through 2019.

Here’s what we missed last week.

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Novo Nordisk wins FDA nod for fast-acting mealtime insulin

NordiskNovo Nordisk (NYSE:NVO) said today that the FDA approved its Fiasp insulin aspart injection.

The fast-acting mealtime insulin is designed to improve glycemic control for adults with Type I and Type II diabetes. The injection can be taken at the start of a meal or within 20 minutes after starting a meal, Novo Nordisk reported.

Get the full story at our sister site, Drug Delivery Business News.

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Why Bigfoot Biomedical’s CEO thinks the diabetes industry has a data problem

Bigfoot BiomedicalBigfoot Biomedical‘s chief executive is excited about Abbott‘s (NYSE:ABT) latest regulatory win – and it’s not just because the two companies have an established partnership.

Yesterday, the FDA approved Abbott’s FreeStyle Libre Flash continuous glucose monitoring system. It’s the first device of its kind, allowing patients to track their blood glucose levels without the use of routine finger sticks.

“It’s a tremendous demonstration that the FDA understands the value of factory calibration and making usage of a sensor simpler and easier,” Bigfoot CEO Jeffrey Brewer told Drug Delivery Business News.

Get the full story at our sister site, Drug Delivery Business News.

The post Why Bigfoot Biomedical’s CEO thinks the diabetes industry has a data problem appeared first on MassDevice.

FDA warns on endoleaks with stent grafts

A. England, R. McWilliams Endovascular Aortic Aneurysm Repair (EVAR) Ulster Med J, 82 (1) (2013), pp. 3-10

Image: Ulster Medical Journal

The FDA yesterday warned physicians about the risk for a dangerous type of leak with endovascular stent grafts used to wall off aneurysms in the abdominal aorta.

The federal safety watchdog said the warning was prompted by an uptick in adverse event reports from physicians and medical device companies of Type III endoleaks in stent grafts used to treat AAA and aorto-iliac-aneurysms. Type III endoleaks result from defects or mis-alignment of the stent graft components, allowing pressure to build in the aneurysm sac and increasing the risk of rupture.

“This increase is compared to earlier clinical update reports in patients with various device models and implant duration lengths, including some patients who had previously stable repairs,” the FDA said.

The agency recommended that doctors maintain lifelong surveillance of patients treated with stent grafts.

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7 medtech stories we missed this week: August 11, 2017

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From Xtant Medical’s 510(k) extension to Varian Medical’s distribution deal, here are seven medtech stories we missed this week but thought were still worth a mention.

1. FDA extends Xtant Medical’s 510(k) for Calix C spinal implant

Xtant Medical announced in an Aug. 9 press release that the FDA has cleared its product line extensions for the Calix-C cervical inter body cages. The clearance allows for two larger footprints to be added for use with allograft. The Calix-C Cervical Interbody Spacer is designed for spinal fusion procedures at level one in patients who are skeletally mature. It is supposed to be used with spinal fixation systems like Xtant Medical’s Spider Cervical Plating and Certex Spinal Fixation Systems.

2. Life Spine touts first use of TiBow spacer

Life Spine has announced the first clinical use of its TiBow MIS TLIF Expandable Spacer System with Osseo Loc Surface Technology in an Aug. 8 press release. TiBow is designed for in-situ expansion for increased endplate coverage and stability for minimally invasive TLIF and oblique approaches. It gives the surgeon the ability to restore sagittal alignment.

3. Cardiac Science inks deal to supply AEDs to Philadelphia schools

Cardiac Science announced in an Aug. 8 press release that it has reached a deal with the School District of Philadelphia to make automated external defibrillators (AEDs) available in all 220 Philadelphia schools. Philadelphia’s high schools and middle schools already have the Cardiac Science Powerheart G3 and G5 AEDs in place and the elementary schools are set to receive the company’s Powerheart G5 units.

4. ApiFix wins nod in Australia

ApiFix has received TGA certification through its Orthotech Pty. distributor to market the ApiFix system in Australia, according to an Aug. 8 press release. The ApiFix system is designed to treat and correct adolescent idiopathic scoliosis (AIS) using a minimally-invasive surgical approach. The system is a non-fusion spinal implant system that is designed to improve the quality of life of patients who have to have scoliosis surgery.

5. Pentax Medical launches slim linear ultrasound

Pentax Medical announced in an Aug. 9 press release that it has launched its new Slim Linear Ultrasound Endoscope in the U.S. The endoscope features a smaller insertion tube, a smaller distal end and a shorter bending section to help endoscopies see and reach hard-to-access anatomy.

6. Hip Innovation launches clinical trial of novel hip replacement system

Hip Innovation Technology has started its clinical trial to evaluate the effectiveness and safety of the HRS lead hip replacement system, according to an Aug. 9 press release. The clinical study will include 100-120 patients who are scheduled to receive a total hip arthroplasty. The company plans to test effectiveness using clinical radiologic, radiostereometric and patient-reported outcomes. It will measure safety through collecting device-related adverse events. They will also assess the quality of life of each patient.

7. Varian Medical inks distribution deal with Bionix radiation therapy

Varian medical Systems announced in an Aug. 9 press release that it has entered an agreement with Bionix Radiation Therapy to distribute the Bionix brachytherapy applicators in North America. Varian has agreed to market the Bionix Esophageal Application (E-App) and the Anorectal Applicator (AR-1). E-App is a disposable brachytherapy applicator that is designed to treat upper GI cancers. It has five independently operated balloons that help maintain the central position of source catheters in straight and curved anatomy. AR-1 is a disposable brachytherapy applicator that is designed to treat anal and rectal cancers. It allows for exophytic tumors to press closer to a source catheter to deliver a very high dose to the tumor while keeping healthy tissues safe.

Here’s what we missed last week.

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SteadyMed tops Q2 sales, EPS estimates

Shares in SteadyMed (NSDQ:STDY) fell today after the pharmaceutical company beat sales expectations on Wall Street with its second quarter results, but missed EPS estimates.

The San Ramon, Calif.-based company posted a net loss of -$8.1 million on sales of $319,000 for the 3 months ended June 30, for bottom-line loss of -14% on sales growth of 239.4% compared with the same period last year.

Get the full story at our sister site, Drug Delivery Business News.

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Deaths prompt renewed FDA warning on intragastric balloons

The FDA yesterday updated its warning of the risks associated with fluid-filled intragastric balloons after receiving new reports of the deaths of patients implanted with the devices.

Intragastric balloons, made by Apollo Endosurgery (NSDQ:APEN) and ReShape Medical, are used to treat obesity. Placed in the stomach orally in a minimally invasive endoscopic procedure, they’re designed to be filled with fluid and stay in the stomach for six months. Apollo’s Orbera intragastric balloon system is composed of a single balloon which is filled with saline, while ReShape’s integrated dual balloon system uses 2 balloons filled with saline and methylene blue dye.

Earlier this year the federal safety watchdog warned of the risk of two types of adverse event associated with the balloons, including over-inflation requiring premature removal and the development of acute pancreatitis, also requiring premature device removal.

Yesterday the FDA said it received five reports of “unanticipated” deaths since 2016 in patients treated with the balloons, four with Apollo’s Orbera and another with ReShape’s dual-balloon system; in a press release, Apollo said there have been five deaths of Orbera patients since the agency approved the device in August 2015.

The FDA said the reports it received since 2016 indicate that the patients died within a month of implantation, with three as soon as three days later. The root causes for the deaths are unknown, the agency said, “nor have we been able to definitively attribute the deaths to the devices or the insertion procedures for these devices (e.g., gastric and esophageal perforation, or intestinal obstruction).”

The FDA also said another two patients died from complications from balloon implantation: a gastric perforation in an Orbera patient and an esophageal perforation in a ReShape patient.

Apollo said it reported all five deaths of Orbera patients in the U.s., Mexico, Brazil and Great Britain to the FDA and has had no indication that any were related to the device or its insertion procedure. No product liability lawsuits have been filed against it, the Austin, Texas-based company said, claiming an incident rate since the beginning of 2006 of less than 0.01%.

“Patient safety is a key priority in everything we do at Apollo Endosurgery and we take adverse event reporting obligations related to our products very seriously. The FDA letter is an important reminder to the physician community that obesity is a serious disease and many obese patients are affected by one or more co-morbid conditions due to their obesity. In our physician training, we are diligent to emphasize the factors that support the safe and effective use of Orbera and we will continue to do so,” CEO Todd Newton said in prepared remarks.

“The FDA’s letter reinforces the fact that complications and adverse events can occur within patients having obesity-related co-morbid conditions. Each patient must be appropriately evaluated prior to the decision to place the balloon, especially the potential risks of anesthesia and an endoscopic procedure. Patients must be monitored closely during the entire term of treatment in order to detect the development of possible complications and each patient should be instructed to contact his or her physician immediately upon the onset of any unexpected symptoms,” added CMO Dr. Christopher Gostout.

APEN shares closed down -23.3% at $4.34 apiece yesterday.

See the best minds in medtech live at DeviceTalks Boston on Oct. 2.

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Study: Abuse-deterrent opioids are costly and unproven

In an attempt to curb the harrowing opioid crisis in America, drugmakers have developed what they tout as “abuse-deterrent” pain-killers – opioid formulations that are designed to prevent users from injecting the drugs.

But a report published this week by the Institute of Clinical and Economic Review found that there isn’t enough evidence to claim that these re-formulated drugs effectively reduce abuse and that the price of abuse-deterrent opioids is a barrier for large-scale adoption.

Get the full story at our sister site, Drug Delivery Business News.

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Trump proposes deep cuts to Medicaid, NIH funding


Capitol HillPresident Donald Trump’s proposed budget would slash Medicaid funding and cut support for major biomedical research programs at the National Institutes of Health and the Centers for Disease Control & Prevention.

The budget blueprint drew condemnation from healthcare advocates and lawmakers from both sides of the aisle. Senate majority whip Sen. John Cornyn (R-Texas) reportedly said earlier this week that Medicaid cuts wouldn’t get through Congress.

“I think the tradition is presidents write budget proposals and that the Senate and the House substitute their own, and so I wouldn’t expect that would carry the day,” he told The Hill.

The potential $610 billion cut to Medicaid would add to the $839 billion cut proposed by the American Health Care Act that passed in the House earlier this month.

The proposal to slash Medicaid funding goes against Trump’s campaign promise to leave Medicaid, Medicare and Social Security funds untouched.

Among the more significant reductions proposed in Trump’s budget are an -19% cut to the National Cancer Institute and a -28% cut to spending on environmental health. The budget would also trim funding for the National Science Foundation by $776 million, or -11%.

According to the president’s proposal, the FDA would receive $1.89 billion in direct government funding. The 31% decrease would be offset by an increase of $1.3 billion in user fees.

Rep. Tom Cole (R-Okla.) said the proposed $5.8 billion cut to NIH funding “penny-wise and pound-foolish”, according to Stat. Cole is the chair of the House health appropriations subcommittee.

The proposal did not include any direct cuts to Medicare.

CDC director Dr. Tom Frieden took to Twitter to respond to the administration’s proposal, calling it an “assault on science.”

Also today, Rep. Tom Macarthur (R-NJ) resigned as co-chairman of the so-called Tuesday Group, a caucus of moderate House Republicans, citing divisions over efforts to repeal and replace former President Barack Obama’s healthcare law, according to a report from Politico. 

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