ACC ’18 Roundup: Abbott releases long-term HeartMate 3 data

Abbott (NYSE:ABT) touted two-year data yesterday from its trial designed to compare the company’s HeartMate 3 left ventricular assist device to its HeartMate 2 device in patients with advanced heart failure.

Data from the study were published in The New England Journal of Medicine and presented at the American College of Cardiology’s 67th Annual Scientific Session.

More than 1,000 patients participated in the study. Researchers assessed the trial’s participants for a short-term endpoint of six months and long-term endpoint of two years.

The two-year cohort met its primary endpoint, achieving 77.9% event-free survival – topping the 56.4% rate seen in patients treated with the HeartMate II LVAD.

Patients treated with the HeartMate 3 device had a survival rate of 82.8% after two years, compared to 76.2% for the HeartMate II group. Abbott also reported that low pump thrombosis rates remained low at 1.2% for the HeartMate 3 group, with no reoperations or pump replacements needed at two years.

Finally, the stroke rate in the HeartMate 2 group was 19% compared to just 10% for the patients treated with HeartMate 3.

“The long-term data for the pivotal Momentum 3 trial demonstrate overall survival of 83% at 2-years and marked improvement in clinical outcomes for our patients suffering with advanced heart failure,” Dr. Mandeep Mehra, medical director of Brigham and Women’s Hospital Heart and Vascular Center, said in prepared remarks. “We have seen greater pump durability—mostly driven by an absence of confirmed pump thrombosis—as well as a significantly lowered stroke rate without an increase in other adverse events.”

“As the leader in LVAD therapy, our goal is to provide patients with life-changing health technology that minimizes risk and offers them an enhanced quality of life. Data from the Momentum 3 study show Abbott’s significant progress in LVAD innovation and how it’s improving patient health outcomes,” Dr. John O’Connell, medical director for Abbott’s mechanical circulatory support business, added.

Abbott’s HeartMate 3 LVAD has CE Mark clearance in the E.U. and is approved by the FDA in the U.S. for short-term use. The company plans to use data from its Momentum 3 trial to support an regulatory bid for a long-term indication for HeartMate 3 in the U.S.

NEXT: Philips touts NEJM study on iFR v. FFR

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Abbott wins FDA nod for pediatric Masters Series mechanical heart valve

Abbott (NYSE:ABT) subsidiary St. Jude Medical won expanded FDA approval today for its Masters Series mechanical heart valve, now cleared in a 15mm size, which the FDA said is the smallest mechanical heart valve approved in the world.

The company’s Masters series mechanical heart valve is a rotatable, bileaflet valve designed for implantation in the aortic or mitral position and consists of two semi-circular discs that open and close in response to blood pressure changes during the heart beat, according to an FDA release.

The newly approved 15mm version of the device clears the valve for use in pediatric patients who previously had no options, the FDA said.

The agency claims that more than 35,000 babies are born in the US each year with congenital heart defects, many of which will require replacement heart valves that, prior to the approval, were not available.

“While larger replacement heart valves have been approved for years, there is an unmet need in young pediatric patients, especially newborns and infants, with congenital valve defects who may be too small to use currently-marketed heart valves,” FDA Center for Devices and Radiological Health director Dr. Jeff Shuren said in a press release.

Approval came based off clinical data from a single-arm study of 20 pediatric patients, between the ages of 1.5 weeks and 27 months, with serious heart failure in which the device was used as a mitral valve replacement.

Data from the study showed that one year post-implant, survival rates were 69.3% while the rate of freedom from valve-related adverse events was 66.8%, according to the FDA release.

Serious adverse valve-related events noted during the study include blood clots in the device and brain bleeds. The FDA said that anticoagulation therapy may be required to help prevent device clotting.

The post Abbott wins FDA nod for pediatric Masters Series mechanical heart valve appeared first on MassDevice.

Study: Abbott’s Nanostim leadless pacers solid at 3 years outside battery redesign issues


Abbott‘s (NYSE:ABT) Nanostim leadless pacemaker was found to be safe and effective after three years, outside of a battery-related malfunction that required a redesign, according to study data reported by Healio.

Data came from the first-in-human Leadless study and was published in a research letter in the journal Circulation, according to the report.

A single patient was reported to have experienced a complication caused by a battery malfunction, which culminated in a battery advisory that was sent to doctors and the redevelopment of battery components, Healio reports.

A total of 33 patients were followed for up to 38 months in the Leadless trial, with a single patient unable to receive the Nanostim device due to a problem.

Survival at three years was reported at 74%, with no deaths reported as being related to the device, according to the report.

The rate of freedom from serious adverse events was reported at 89.9% at 40 months, with three patients experiencing device-related complications, according to Healio.

One patient had a reported procedure-related perforation leading to cardiac tamponade, another had an inadvertent placement of the device through a patent foramen oval leading to removal and re-implantation, while the last had a battery malfunction at 37 months that caused loss of communication, with the device being removed and replaced, according to the report.

No incidents of late device dislodgements, device infections or pacemaker syndrome were reported, and at three years electrical performance of the device was reported as being adequate, Healio reports.

“The overall [leadless cardiac pacemaker] complication rate of 10.1% is comparable to previous reports of transvenous pacemaker complications. Development of a new battery should resolve [the battery malfunction] issue. The adequate performance and freedom from [serious adverse device effects] at midterm follow-up in this first-in-humans patient cohort support the use of leadless pacing as an alternative to transvenous pacing, especially considering the promise of decreasing long-term pacemaker complications,” study author Dr. Fleur Tjong of Amsterdam’s AMC Heart Center said, according to the report.

Masimo wins CE Mark for Eve newborn CCHD screening app


Masimo (NSDQ:MASI) said today it won CE Mark approval in the European Union for its Eve critical congenital heart disease newborn screening application which runs on the company’s Rad-97 and Radical-7 pulse co-oximeters.

The Eve application is designed to streamline CCHD screenings by providing visual instructions, animations and automatic synchronization algorithms with a detailed display of screening results, the Irvine, Calif.-based company said.

Eve also enables the incorporation of perfusion index measurements into screening, which Masimo said has been shown to increase sensitivity to the detection of CCHD in infants with pathologically low perfusion rates.

“Multiple studies have shown that Masimo SET pulse oximetry can help improve CCHD screening, helping to save many newborns’ lives while reducing the cost of care. Eve builds on the powerful benefits of SET by transforming pulse oximeters into intuitive screening tools which can help clinicians perform the crucial work of screening newborns in an easy-to-follow and intuitive application,” CEO Joe Kiani said in press release.

Last month Masimo released results from a study of its Oxygen Reserve Index’s ability to function as an early warning of impending arterial hemoglobin desaturation in obese patients, touting its ability to provide advanced warning in the high risk patient population.

7 medtech stories we missed this week: Jan. 19, 2018

missed medtech aug 4

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From Privi Medical’s FDA clearance to OrthoXel getting FDA clearance and CE Mark approval, here are seven medtech stories we missed this week but thought were still worth mentioning.

1. Privi Medical wins FDA nod for hemorrhoid device

Privi Medical has received FDA clearance for its Instalief Hemorrhoids Treatment device, according to a Jan. 18 news release. The device is disposable and uses an advanced instant cold compression technology to treat hemorrhoids.

2. Centric Medical gets FDA 510(k) clearance for foot & ankle screws

Centric Medical announced in a Jan. 16 news release that it has received FDA 510(k) marketing clearance for its Cannulated Screw Internal Fixation System. The system features foot and ankle screws that can be used in foot and ankle reconstruction procedures. It is a multi-component system made of titanium alloy that comes in a variety of diameters and lengths.

3. BioPoly receives CE Mark for knee implants

BioPoly has received CE Mark for its RS Partial Resurfacing Trochlea system, according to a Jan. 16 news release. The partial resurfacing knee portfolio can treat focal cartilage defects in femoral condyles, trochlear facts, trochlear groove and patella. The company plans to launch the system in the next few months.

4. Avacen launches dry-heat therapy autism device in India

Avacen announced in a Jan. 17 press release that it has launched its Avacen 100 dry-heat therapy autism device in India. The device is an FDA-cleared, CE Mark Class II therapy device designed to provide relief of autistic behavior. Avancen 100 safely and non invasively warms the body by infusing heat into the circulatory system. The device has been shown to improve speech impediments, increase classroom participation and an improvement of school grades.

5. FDA approves Zoll Medical’s full AED line

Zoll Medical has received premarket approval from the FDA to market and distribute its full line of defibrillators in the U.S., according to a Jan. 9 press release. The company’s R Series, X Series, AED Pro and AED Plus have all received premarket approval. Each device uses Zoll’s rectilinear biphasic waveform to deliver maximum current to high-impedance patients.

6. Sealantis wins CE Mark for surgical sealant

Sealantis announced that it has received CE Mark for its Seal-G surgical sealant, according to a Jan. 12 press release. The sealant is designed to reduce leaks after gastrointestinal procedures. Seal-G stops anastomotic leaks by reinforcing suture or staple lines during post-surgery. The sealant will be available in Europe as it has not yet received FDA approval.

7. OrthoXel wins FDA nod, CE Mark for Apex tibial nailing device

OrthoXel announced in a Jan. 16 press release that it has received FDA 510(k) clearance and CE Mark approval for its Apex Tibial Nailing System. The company can now commercialize the system in the U.S. and Europe. The device allows surgeons to have a wide range of locking options of intramedullary nail. Its micromotion locking mode allows for controlled axial movement with torsional stability.

These medtech companies raised the most VC last year


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Perhaps there’s a ray of hope that venture capital funding is recovering a bit for the medical device industry.

VC firms invested more than $2.8 billion in 2017, an increase of more than $647 million from 2016, according to the MoneyTree Report from PricewaterhouseCoopers (PwC) and CB Insights. There were a total 229 deals involving medical device companies last year.

The companies raking in the VC cash are doing everything from creating robotic microsurgery for the eyes to building better dialysis machines to bringing neuromodulation to bear on epilepsy.

Read on to discover which medtech companies raised the most venture capital in 2017.

Next >>

Cardiovascular Systems inks partnerships with OrbusNeich, Integer

  • These medtech companies raised the most VC last year

    Perhaps there’s a ray of hope that venture capital funding is recovering a bit for the medical device industry. VC firms invested more than $2.8 billion in 2017, an increase of more than $647 million from 2016, according to the MoneyTree Report from PricewaterhouseCoopers (PwC) and CB Insights. There were a total 229 deals involving […]

  • Medtech stories we missed this week: Jan. 19, 2018

    From Privi Medical’s FDA clearance to OrthoXel getting FDA clearance and CE Mark approval, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Privi Medical wins FDA nod for hemorrhoid device Privi Medical has received FDA clearance for its Instalief Hemorrhoids Treatment device, according to a Jan. 18 news […]

  • How blockchains could empower patients and secure data

    Blockchains are best known as the technology behind cryptocurrencies such as Bitcoin. But the founders of a young Atlanta-based company called Patientory think they could have another important use – securing health data and empowering patients along the way. Secure access to patient data is a major issue for the healthcare industry. Patients have a […]

  • Phillips-Medisize’s increased business to benefit Molex plant in Arkansas

    Phillips-Medisize today announced a doubling of production for an undisclosed fast-growing medical customer with a take-home diagnostic kit for cancer detection – with benefits for the plant that Phillips-Medisize’s parent Molex runs in Little Rock, Ark. Phillips-Medisize, which is based in Hudson, Wis., did not disclose the identity of the customer, which it described as a leader […]

  • GlobTek touts EAC-certified off-the-shelf power supplies for medical, other applications

    GlobTek is touting the wide variety of EAC-certified power supplies that it is offering for applications including medical, information technology equipment, household and more. A full list is available on the Northvale, N.J.–based company’s website.  EAC certification, formerly known as the Russian GOST-R certification, implements a new logo (EAC mark)  – and involves the implementation […]

  • Robotic spine surgery is getting a real-time image guide boost

    For the first time, surgeons at Johns Hopkins Hospital were able to harness real-time image guidance during a robotic spine surgery procedure to insert screws into a patient’s spine. The process offers a marked improvement over the accuracy of placement compared with other image-guided procedures. Dr. Nicholas Theodore – professor of neurosurgery at the Johns Hopkins University […]

  • Cardiovascular Systems inks partnerships with OrbusNeich, Integer

    Cardiovascular Systems (Nasdaq: CSII) announced today that it is expanding its product portfolio through new partnerships with OrbusNeich and Integer. The OrbusNeich partnership makes St. Paul, Minn.–based CSI the exclusive U.S. distributor of Hong Kong–based OrbusNeich‘s balloon products. The deal with Frisco, Texas–based Integer (NYSE: ITGR) involves Integer producing CSI-branded Zilient guidewires. Cardiovascular Systems CEO […]

  • FDA to expedite release of recall information

    Douglas Stearn, FDA When FDA identifies that a product it regulates violates the law, it protects the public by working with the manufacturer and distributors to facilitate the product’s recall (i.e., removal from the marketplace or product correction). Among other actions, FDA assures that the public is warned when products present the most significant public […]

  • IRS won’t enforce penalties on medical device tax

    The U.S. Internal Revenue Service yesterday said it won’t enforce penalties on companies making late payments on the medical device tax for the first three months of this year. The 2.3% excise tax on U.S. medical device revenues was in effect for two years before a two-year moratorium went into effect for 2016 and 2017. It went […]

  • Is tax reform good or bad for medical device companies?

    Medical device companies and others in the healthcare sector stand to benefit from the tax reform Congress passed at the end of 2017, but the picture isn’t entirely rosy, according to a new report from S&P Global Ratings. In many ways, the report offers a corrective to the bullish statements coming from corporate CEOs such […]

  • FDA releases top 3 medical device regulation goals

    FDA medical device regulators’ top priorities over the next three years include improving employee engagement, increasing simplicity and building collaborative communities, according to a new Strategic Priorities paper that FDA’s CDRH released today. The agency said the priorities further its overall goal of providing Americans with more timely access to the latest high-quality, safe and effective medical devices. […]

  • Miracor closes $30m Series D

    Miracor Medical Systems said today it closed a $30.2 million (EU €25 million) round of funding as part of Series D financing round with funds slated to support further development and commercialization of its PiCSO impulse system, and announced it is moving its headquarters from Austria to Belgium.

    The company’s PiCSO therapy is designed to be used during stenting procedures for patients affected by acute myocardial infarcts to improve pressure in the coronary venous system to improve microcirculatory flow and improve perfusion in the infarcted area.

    The round was led by Shenzhen, China-based Ming Capital and co-led by a strategic investor and joined by newly invested SFPI, SRIW and Meusinvest and existing investors Earlybird Venture Capital, Delta Partners, SHS Gesellschaft für Beteiligungsmanagement, Biomed Invest and Peppermint Venture Partners.

    “Miracor Medical has shown that the PiCSO Impulse System may reduce infarct size and improve cardiac function. We are impressed with the company’s performance and the latest clinical data on the PiCSO Impulse System, which show statistically significant better results for PiCSO-treated patients in a propensity score matched control. PiCSO has global potential and we look forward to supporting and partnering with Miracor Medical to improve the outcomes of patients following acute infarcts and bring the PiCSO Impulse System to the next stage of clinical development,” Ming Capital managing partner Jack Yang said in a press release.

    As part of the financing round, whicn included both equity and debt and a non-dilutive cash advance from Wallonia’s government, the company said it is relocating its headquarters to Belgium.

    “I am very excited by the prospects for the company. The funds will allow us to run a randomized clinical trial in Europe, work with FDA to get approval for a large US trial and bring the PiCSO therapy to the market in Europe. I wish to thank all the investors for their trust, especially the Austrian (aws Gründerfonds) and Belgian public investors that allow for this important financing and step towards getting the PiCSO therapy accessible to patients,” Miracor CEO Olivier Delporte said in a prepared statement.

    The post Miracor closes $30m Series D appeared first on MassDevice.

    Cardiovascular AI imaging dev Bay Labs raises $6m in Series A


    Bay Labs

    Cardiovascular artificial intelligence medtech firm Bay Labs said today it raised $5.5 million in a Series A round to support clinical validation and further development of its cardiovascular imaging tech.

    The round was led by existing investor Khosla Ventures and joined by newly invested Data Collective, Greenbox Venture Partners, Minneapolis Heart Institute Ventures and Georges Harik. As part of the funding round, Khosla Ventures general partner Ben Ling and DCVC operating partner Armen Vidian will join the San Francisco-based company’s board of directors.

    “Bay Labs’ unique application of AI with ultrasound has the potential to enable medical professionals to provide faster and better care to patients. We are excited to increase our investment in Bay Labs to revolutionize ultrasound,” Khosla Ventures general partner Ben Ling said in a prepared statement.

    “We are impressed with the strength of the Bay Labs AI engine to bring consistently high-quality ultrasound images and key data to physicians when they need it most – at the point of care, and we are especially excited to see such early enthusiasm from some of the world’s leading physicians. We see tremendous potential for this intelligent, data-rich technology to impact how and when physicians direct patient care to dramatically improve outcomes,” DCVC operating partner Armen Vidian said in prepared remarks.

    Bay Labs AI-assisted cardiovascular imaging tech is being designed to help diagnose and manage heart disease. The system uses deep learning technology to help perform and interpret echocardiograms with the goal of improving treatment of heart disease.

    The company said it has partnered with the Minneapolis Heart Institute and Allina Health, Northwestern Medicine, Duke University School of Medicine and Stanford University cardiologists to develop the deep learning algorithms for its system.

    “We’re gratified by the continued support from our existing investor Khosla Ventures and we welcome our new investors — all of whom share our vision about how deep learning technology can address two key problems in diagnostic cardiology: acquisition and interpretation of echocardiograms. We welcome Ben Ling and Armen Vidian as board members and look forward to their strategic contributions to our efforts to enable providers in achieving high-quality cardiac imaging results to improve patient care,” Bay Labs co-founder & CEO Charles Cadieu said in a press release.

    CytoSorbents wins German gov’t funding for CytoSorb endocarditis trial



    CytoSorbents (OTC:CTSO) said this week it won funding from the German Federal Ministry of Education and Research for a randomized controlled trial exploring the use of its CytoSorb blood purification technology for treating infective endocarditis.

    The newly funded randomized, controlled, multi-center Remove trial aims to enroll 250 patients to explore the safety and efficacy of intraoperative CytoSorb in patients with dangerous bacterial heart valve infections during valve replacement surgeries and cardiopulmonary bypass procedures, the Monmouth, N.J.-based company said.

    The study’s goal is to demonstrate improved hemodynamic stability and reduced organ injury, primarily measured by change in the sequential organ failure assessment score, with secondary endpoints of 30-day mortality, need for supportive care therapies and length of intensive care and in-hospital stays.

    “We are very grateful to the German government for their commitment to fund the Remove trial in its entirety, and to Prof. Dr. med. Frank Brunkhorst, the Center for Clinical Studies Jena, and Jena University Hospital for sponsoring the study.  Infective endocarditis, or infection of a heart valve, can destroy the valve in hours to days, and can rapidly lead to emergency open heart valve replacement surgery in very sick patients that suffer from both sepsis and heart failure.  Patients are often unstable before, during, and after the surgery, and are prone to a high risk of complications and death, as well as a costly and lengthy hospital stay.  This is a rapidly growing problem, driven by the aging population and the opioid crisis, where the use of dirty needles by intravenous drug abusers can lead to seeding of bacteria in the bloodstream and heart valve infection,” CEO Dr. Phillip Chan said in a prepared statement.

    CytoSorbents expects the trial to begin early next year, in collaboration with Thermo Fisher Scientific’s B.R.A.H.M.S and the Fraunhofer Institute for Interfacial Engineering and Biotechnology.

    “This announcement of funding and collaboration follows our previous press release on October 19, 2017 highlighting the largest published endocarditis case series to date, where the intraoperative use of CytoSorb during emergent and urgent valve replacement surgery helped to improve hemodynamic stability, reduce the need for vasopressors, and was associated with a reduction of in-hospital mortality compared to a historical control.  We believe that similar results could be seen in the Remove trial.  Interestingly, the Remove study will parallel our Refresh 2 pivotal, registration trial in the U.S., designed to support FDA regulatory approval.  The Refresh 2 trial will also focus on the intraoperative use of CytoSorb during valve replacement surgery – but specifically excludes infective endocarditis – to reduce the incidence or severity of post-operative organ dysfunction. If successful, the two trials could rapidly lead to the use of CytoSorb as standard of care in most, if not all, open heart valve replacement surgeries, which accounts for hundreds of thousands of procedures worldwide,” CEO Dr. Chan said in a press release.

    In May, CytoSorbents presented results from the Refresh trial of its CytoSorb blood purification tech, touting that the trial met its safety goals and that treatment reduced toxic inflammatory mediators during complex heart surgery.