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.

The post Deaths prompt renewed FDA warning on intragastric balloons appeared first on MassDevice.

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.

The post Study: Abuse-deterrent opioids are costly and unproven appeared first on MassDevice.

Trump proposes deep cuts to Medicaid, NIH funding

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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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    FDA labels Philips Respironics V60 ventilator recall as Class I

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    Philips Respironics

    The FDA today labeled a recall of Royal Philips (NYSE:PHGRespironics‘ V60 ventilators as Class I.

    Class I recall designations, the agency’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.

    The Respironics V60 non-invasive ventilator is designed to provide continuous or intermittent breathing support to pediatric patients weighing at least 44 lbs or adult patients, according to the recall notice.

    The company is recalling the device over issues with pins within the internal cable that connects the ventilator’s motor to the control board which can become loose due to vibrations. A loose pin may prevent data from being transferred between the motor and control board, according to the FDA release, which could cause the ventilator to shut down unexpectedly and sound an alarm.

    An unexpected stop in ventilation could cause serious adverse health consequences, including death, the FDA said.

    The recall affects 20,690 V60 non-invasive ventilator units in the US manufactured between April 2, 2009 and Sept. 15, 2015 and distributed between April 4, 2009 and Sept. 14, 2015.

    In March, Philips Respironics recalled a select number of its V60 respiratory ventilators with version 2.20 software over issues with the software causing the blower motor to stall and the unit to shut down, according to a recall notice released this week.

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    Soterix Medical wins FDA 510(k) for IontoDC

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    Soterix Medical

    Soterix Medical said today it won FDA 510(k) clearance for its IontoDC device designed to use direct current to introduce ions of soluble salts and other drugs  into the body.

    The New York-based company said that the newly-cleared IontoDC device provides 10, 20, 30 or 40 minutes of direct current at intensities varying between 1 and 2 mA, and includes resistance meters and automatic ramp up and down.

    “This clearance represents a significant milestone for our organization as we can now offer the IontoDC system to the medical community in the U.S. The IontoDC was designed for ease-of-use including simple controls and clear status displays.” regulatory affairs VP Renato Moratore said in a prepared statement.

    “The FDA clearance of this system builds on the reputation of Soterix Medical in providing equipment engineered to the highest medical device standards. The IontoDC technology is proven to provide exceptionally reliable and consistent performance.” CTO Dr. Abhishek Datta said in a press release.

    Last September, Soterix Medical said it won Health Canada approval for and launched its PainX transcranial direct current stimulation technology designed for treating pain disorders in adults.

    The PainX tDCS system is a non-invasive, battery-powered device designed to deliver mild current to a specific section of the cerebral cortex to modulate reaction to painful experiences or control pain perception, Soterix said. The company touted the device as a “highly-promising therapy” that avoids systemic side effects associated with oral pain medications.