FDA clears Edwards Lifesciences hypotension index software

Edwards Lifesciences (NYSE:EW) said today it won FDA de novo approval for its Acumen Hypotension Prediction Index software designed to address potential hypotension in surgical patients.

The Irvine, Calif.-based company said it is engaging in a targeted launch of the system in the US following the approval, which clears the software as an adjunctive predictive cardiovascular indicator.

“The Acumen Hypotension Prediction Index is a next-generation, predictive monitoring software that represents the future of how we can use patient data to improve healthcare. HPI improves patient care by providing intelligent decision support, moving beyond descriptive monitoring to facilitate predictive monitoring, which provides more clarity on a patient’s condition to enable clinicians to make more proactive decisions,” Edwards critical care corp. VP Catherine Szyman said in a press release.

The HPI software uses algorithms to analyze cardiovascular vital signs to predict future events and cardiovascular status, Edwards said. The system is only compatible with Edwards hemodynamic monitoring solutions. Analytics within the HPI are powered by a data driven model developed from more than 200,000 patient events.

The system includes the HPI software, an alarm to alert when the HPI exceeds the upper threshold and a secondary screen to link blood pressure and hemodynamic flow parameters to identify causes of low blood pressure, the company said.

“Even brief periods of hypotension are associated with complications or, worse, death after surgery. As blood pressure during surgery decreases, mortality increases. A software that enables clinicians to detect and address potentially developing hypotensive events before they occur is a major and unique advancement in improving patient care,” Dr. Maxime Cannesson of UCLA said in a prepared statement.

Earlier this month, reports emerged that Edwards Lifesciences is planning to build a plant in Ireland that could employ as many as 600 workers by 2020.

The post FDA clears Edwards Lifesciences hypotension index software appeared first on MassDevice.

Perflow Medical closes $12m round to support Stream Net thrombectomy device


Israel-based neurovascular device developer Perflow Medical said it closed a $12 million round of financing to help support its Stream dynamic neuro-thrombectomy net designed for treating acute ischemic stroke.

Funding from the round will support the European commercialization of the company’s first product, the Stream Net device, and a 510(k) submission to the FDA in pursuit of US approval.

Funds will also help support development of two new products based off the company’s Cerebral Net technology platform for aneurysm neck bridging and flow diversion procedures.

The Stream Net device is designed to treat acute ischemic stroke and offers full device control of the braided net diameter, length and radial force for dynamic wall apposition and improved clot retention during revascularization procedures, the company said.

“The Stream Net offers a new level of control that expands a physician’s options to respond in real-time. My early experience with the system has been positive and I see it as a valuable addition to the market,” Dr. Marc Ribó of Barcelona, Spain’s Hospital Vall d’Hebron said in a prepared statement.

The round was joined by existing investors, two new international investors and an unnamed strategic investor, Perflow Medical said.

“This financing is a significant step and reflects the strong commitment our investors have to Perflow and the value of our proprietary Cerebral Net technology to empower physicians to improve outcomes. The clinical experience of the Stream Net device in Europe has been very encouraging and these funds will accelerate our ability to bring this life-saving technology to the market and continue to iterate novel neurovascular solutions using Cerebral Net technology,” CEO Danny Farin said in a press release.

Stryker wins expanded FDA indications for Trevo thrombectomy device


Stryker (NYSE:SYK) said today it won expanded FDA indications for its Trevo thrombectomy device, now cleared as a front-line treatment for acute ischemic stroke patients for up to 24 hours from symptom onset.

The expanded indication lifts the previously cleared treatment window by 18 hours, according to the Kalamazoo, Mich.-based company.

“The 24-hour indication opens the treatment window to patients whose stroke would previously have progressed until all the brain tissue surrounding the affected arteries was dead, leaving them with a life of significant disabilities. These patients now have a much better chance for an independent life without disability,” Dr. Raul Nogueira of Grady Memorial Hospital and Emory University said in a prepared statement.

“FDA clearance of the Trevo retriever has effectively quadrupled the treatment window from zero-six hours to zero-24 hours from time last seen well. Nonetheless, every minute still matters because in each individual patient, the earlier the blood flow is restored to the brain, the lower the resultant burden of permanent brain damage. Therefore, it is still imperative that all caregivers in the stroke pathway – from EMS to emergency room physicians to stroke neurologists to interventionalists – continue to deliver the fastest and most workflow-efficient treatment of stroke,” Dr. Tudor Jovin of the University of Pittsburgh Medical Center said in a prepared release.

Stryker said that the expansion is in line with recently updated guidelines from the American Heart Association and the American Stroke Association.

“This expanded indication for Trevo marks a significant milestone in the treatment of stroke patients who suffer from this catastrophic disease. We believed this future was possible, which is why we invested in the Dawn Trial. Through our efforts to help patients suffering from ischemic stroke, we are living our mission to make healthcare better,” Stryker neurovascular prez Mark Paul said in a press release.

Last November, Stryker released results from the Dawn trial of its Trevo thrombectomy device, touting significant effects even when used beyond six hours after stroke.

Penumbra touts non-inferiority in Compass aspiration thrombectomy trial


Penumbra (NYSE:PEN) late last month released results from the Compass trial of its aspiration thrombectomy system designed to treat acute ischemic stroke, touting that the system was shown to be non-inferior to stent retrievers.

Results from the trial were presented at the International Stroke Conference, the Alameda, Calif.-based company said.

Investigators in the trial aimed to compare the use of Penumbra’s aspiration thrombectomy system, which uses a suction to remove clots, against traditional stent retrievers in treating patients with acute ischemic stroke.

Results from the study indicated 52% of patients treated with the Penumbra aspiration system achieved the primary endpoint of a modified Rankin Score of 0 to 2 within 90 days compared to 49% of patients treated with stent retrievers.

“The primary outcome was demonstrating non-inferiority in clinical outcome between the patients, and it’s the first trial designed specifically to access clinical outcome in non-inferiority between these two cohorts. The results demonstrate clearly non-inferior outcomes, with 52% of the aspiration first cohort achieving independence and 49% of the second cohort demonstrating independence, and the persistence of non-inferiority was consistent across multiple sensitivity analyses,” lead investigator Dr. J. Mocco of the Icahn School of Medicine at Mount Sinai told MassDevice.com in an interview.

Final revascularization rates were similar between both cohorts, with 92% of patients treated with Penumbra’s aspiration system achieving mTICI 2b-3 revascularization versus 89% of the stent retriever cohort. A total 38% of patients in the aspiration arm achieved TICI 3, versus 29% of patients in the stent retriever arm.

Secondary safety points, including embolization in new territory and symptomatic intracranial hemorrhage were not statistically different between cohorts.

The results are bigger than just non-inferiority to Dr. Mocco, who said he’s hopeful that these results, along with other studies on thrombectomy systems, will increase the likelihood and availability of such procedures to patients who desperately need them.

“There’s a tremendous amount to still be learned, both in the approach and technical components of thrombectomy, as well as in patient selection, and that’s most importantly in patient access. What I hope is that, with Compass, the conversation can move beyond an over-emphasis of a specific technology versus another and allow the community to focus on these incredibly important issues of patient selection and patient access. Right now, approximately 10% of patients that could benefit from thrombectomy have a shot at getting thrombectomy. So, there is clearly a dire need for us to prove our ability to get patients these important therapies, and it’s better if Compass’ results help to step along that path – that’d certainly be a tremendous win,” Dr. Mocco said.

The data also reinforced previous results from Penumbra trials of the aspiration system, the company said, and serves as the first in three randomized trials using the Ace 68 reperfusion catheter with the Penumbra system.

“The Compass Trial, together with the Promise, Aster, and 3D Trial results, provides overwhelming evidence that the Adapt technique with the Penumbra System is a proven frontline approach. Notwithstanding this great data, Penumbra will continue to innovate and improve its Penumbra System; however, all of us in the stroke field now have an obligation to ensure all ischemic stroke patients have access to hospitals that offer mechanical thrombectomy for the best possible outcomes,” chair, CEO & prez Adam Elsesser said in a press release.

Earlier in January, Penumbra released results from the Promise real-world safety and efficacy study of its Penumbra System with ACE 68 and 64 reperfusion catheters as a treatment for patients with acute ischemic stroke, touting high rates of revascularization and low rates of all-cause mortality.

J&J’s Cerenovus launches Galaxy G3 mini embolic coil, touts Arise II Embotrap study data


Johnson & Johnson‘s (NYSE:JNJ) Cerenovus division this week announced the launch of its Galaxy G3 Mini embolic coil and released data from a study of its Embotrap device designed to remove clots from the brain following ischemic stroke.

The Galaxy G3 Mini coils are designed to be approximately 25% softer than the Galaxy G3 xsft coils, with an ultra-low coil profile and a primary wind diameter of 0.009 inches, which Cerenovus said is the lowest profile available in its Spectra line.

The newly launched coil is designed to have a random complex shape to make it comformable and enable the device to seek and fill open spaces in cerebral aneurysms for higher packing densities, which the company said has been shown to lower patient retreatment rates.

“Now, Cerenovus brings a family of endovascular coils that offers physicians a total procedural solution that can be used from start to finish or from periphery to core. We will continue to work to advance the treatment of cerebral aneurysm and both hemorrhagic and ischemic stroke to help physicians give stroke patients a new lease on life,” J&J medical devices cardiovascular & specialty solutions group chair Shlomi Nachman said in a press release.

Cerenovus also released data from the Arise II study of its Embotrap device, touting high success rates in restoring blood flow with high rates of functional independence in patients treated with the device.

Data from the study was presented this week at the American Stroke Association’s 2018 International Stroke Conference, the company said.

Results from the 228-patient trial indicated that 80% of patients treated with the Embotrap device experienced restored blood flow within three passes, and that vessels were opened in 93% of patients by the end of the procedure. Substantial reperfusion was also achieved with a single pass in 50% of patients, and 67% of patients were reported to be functionally independent at 90-day follow-ups.

“I believe the EmboTrap device will be an important new option for treating stroke patients. The study results look strong with very encouraging outcomes achieved for reperfusion, modified Rankin Scale, speed to revascularization as well as the rate of first pass success,” Dr. Osama Zaidat of St. Vincent Mercy Hospital said in prepared remarks.

“We were honored to work with an eminent team of international physicians committed to advancing stroke therapy. We are pleased that both the Arise II results, and the physician feedback during the study reflect positively on the Embotrap device design and the extensive clot research which forms its foundation. This research underpins our commitment to developing evidence-based stroke solutions to enhance patient care,” Cerenovus ischemic stroke clinical & regulatory head Mairsíl Claffey said in a prepared statement.

Last September, Johnson & Johnson launched the Cerenovus brand, which combined its Pulsar Vascular  and Neuravi acquisitions and its remaining Codman Neuro neurological portfolio.

Laminate Medical launches study of VasQ hemodialysis fistula device


Laminate Medical Technologies

Laminate Medical Technologies said today it launched a pivotal, FDA-cleared trial of its VasQ implanted blood vessel device designed for patients requiring arteriovenous fistulas as vascular access for hemodialysis.

The Israel-based company’s VasQ device is designed to aid kidney failure patients in need of dialysis by providing external support to reduce fistula failure. The device regulates flow by constraining and shaping the fistula and reinforces and shields the perianastomotic vein against high pressure, wall tension and flow levels, the company said.

The first procedures in the trial were recently performed by Dr. Jason Burgess and Dr. Paul Orland at Charlotte, N.C.’s Carolinas Medical Center-Mercy, Laminate said.

“We are excited to be the first site that enrolled patients in the US. The device was easy to implant and I am happy with the surgical results. We are looking forward to evaluating the device’s long term effect,” Dr. Burgess said in a press release.

“The device was easy to handle and I was very happy with the postoperative results. This new technology is targeting the major problems of AVFs: maturation and long term longevity of the fistula,” Dr. Orland said in a prepared statement.

The trial is a two-year, prospective, multi-site, 129-patient study of the device in patients who require the creation of a brachiocephalic fistula.

Study researchers will assess additional eligibility criteria in the trial, including adequate blood vessel anatomy and possible past and current medical conditions and co-morbidities that would preclude participation, the company said.

Primary effectiveness endpoints for the trial will be primary patency rates at 6 months post-creation of the fistula, with patients followed up to 2 years, Laminate Medical said.

“The launch of this pivotal study marks an important step forward for VasQ in the US market and a promising milestone for patients with kidney failure. We were excited to see the high level of interest and support from our partner sites, when we offered them to participate in the study,” Laminate CEO Tammy Gilon said in a prepared release.

Last August, Laminate said it won FDA investigational device exemption approval to launch a trial of its VasQ implanted blood vessel device.

Singapore vascular access dev Advent Access raises $2m in pre-Series A


Advent AccessSingapore-based vascular access dev Advent Access has raised $1.9 million (SGD $2.6 million) in a pre-Series A financing round to support its av-Guardian technology designed to create vascular access for dialysis patients.

The funding round was led by Accuron MedTech, which the company touted as the largest medical device company in southeast Asia. The investment went through Singapore’s Spring Seeds Capital-assigned accelerator the Med Tech Alliance, Advent Access said.

“We are excited to lead the pre-Series A investment in Advent Access given the company’s strong progress and potential to transform and optimize how care is provided to patients in the S$100 billion global dialysis market. As Southeast Asia’s largest medical device company, this investment reflects our continued belief in Asia’s vibrancy as a hub for disruptive healthcare technologies to develop and thrive. Our investment in Advent Access is Accuron MedTech’s tenth transaction in building a strong portfolio of the most promising innovations which can make a significant difference to healthcare outcomes in Asia and around the world,” Accuron MedTech group chief exec Abel Ang said in prepared remarks.

“We are excited to have Temasek-backed Accuron MedTech onboard. Abel and the Accuron team bring deep experience in growing technologies from Asia, breadth in accessing international markets and financial depth in nurturing startups that will set us apart regionally and internationally. Advent Access is now well equipped to accelerate the development of av-Guardian and tackle some of the most pressing needs in end stage renal disease. Working closely with Accuron, we look forward to unlocking the future of independent dialysis,” Advent Access CEO Peh Ruey Feng said in a press release.

The company’s av-Guardian is a device-guided needling platform featuring the company’s “guardian guide-door” technology for accessing arteriovenous fistulas, which it claims can reduce wear and tear on the dialysis patient’s veins.

Funds from the round will go towards the filing of CE Mark registration in the European Union, which the company said it hopes to submit within the next 18 months.

Advent Access said that a recent clinical trial of the device showed that it was safe and achieved appropriate clinical performance. The company said it plans to publish full results from the study early next year, with a second clinical study already underway.

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.

GE, Golden Meditech ink cord blood storage deal


GE Healthcare, Golden Meditech

GE Healthcare (NYSE:GE) and Golden Meditech said this week they inked a strategic collaboration deal to provide GE’s integrated and automated digital systems and solutions to Golden Meditech for use in its umbilical cord blood cryopreservation processes.

Hong Kong-based Golden Meditech said that umbilical cord blood contains rich hematopoietic stem cells which could facilitate reconstruction of hematopoietic and immune systems with possible applications in stem cell transplantation and other treatments.

Through the partnership, Golden Meditech will use fully automated cell processing systems and associated tools and kits to meet requirements for cord blood processing, according to a press release.

In September, GE Healthcare said it won FDA 510(k) clearance for its Senographe Pristina Dueta, which it claims is the 1st patient-assisted mammography device that allows women to control their own compression during the examination.

HeartFlow wins CMS new tech payment classification for FFRct analysis


HeartFlow said today that the Centers for Medicare & Medicaid Services finalized a new technology ambulatory payment classification for its HeartFlow FFRct analysis designed to help diagnose suspected coronary artery disease.

Under the newly finalized payment decision, Medicare-enrolled hospitals will be eligible for reimbursements of $1,450.50 for each technical component of the FFRct analysis. The new rules are set to take effect on January 1, 2018.

“CMS’s decision to assign a New Technology APC for FFRct technology for Medicare recipients is a recognition of the value of this technology and its demonstrated ability to reduce the number of invasive diagnostic coronary angiography procedures and help medical centers reduce costs. The HeartFlow Analysis is an important tool in helping us assess patients with suspected coronary artery disease and better understand how their coronary blockages affect blood flow to the heart,” Dr. Pamela Douglas of Duke University said in a press release.

Redwood City, Calif.-based HeartFlow’s FFRct technology works by taking the data from a standard CT scan and applying algorithms that result in a color-coded 3D “map” detailing the changes in flow across coronary lesions.

“The decision by CMS will help in the diagnosis and treatment of patients with suspected CAD and means the number of patients over age 65 who will have access to this technology will significantly increase. At our center, the use of the HeartFlow FFRct Analysis is transforming how we diagnose and treat patients with coronary artery disease, helping us move closer to achieving the triple aim of improving the patient experience, improving the health of our patients, and reducing healthcare costs at our institution.” Dr. Daniel Simon of the Cleveland Medical Center said in a prepared statement.

In late August, HeartFlow said it won positive medical policies for its HeartFlow FFRct fractional flow reserve analysis system from 3 separate Blue Cross Blue Shield providers.