FDA approves ReCor Medical’s pivotal ultrasound denervation study

ReCor Medical said this week that the FDA approved a new pivotal study of the company’s Paradise ultrasound denervation system for the treatment of hypertension.

The Palo Alto, Calif.-based company reported that its trial, Radiance-II, will be a randomized, sham-controlled study in patients with moderate hypertension. The study is designed to demonstrate the Paradise system’s safety and ability to lower blood pressure.

ReCor plans to start enrolling patients for Radiance-II in October.

“We have had a very constructive dialog with the FDA during the past 9 months to craft what we believe is a strong study to develop a robust set of clinical data to support the future FDA review for PMA approval,” Leslie Coleman, VP of regulatory & medical affairs, said in prepared remarks. “At the time of PMA submission we plan to have 4 independently-powered, blinded, sham-controlled, randomized studies of the Paradise System in patients with different stages  of hypertension – our Solo, Trio, Require, and Radiance-II studies – approaching a total of nearly 500 subjects, with outcomes as long as 3 years.”

“Our steering committee and medical advisors have been instrumental in the design of the global Radiance clinical program – including the Radiance-II pivotal study – for the US, EuropeJapan and Korea,” Helen Reeve-Stoffer, VP of clinical affairs, added. “Given the recent positive Solo results, and subsequently the numerous review articles in medical journals, we recognize the potential impact the Paradise System may have in the treatment of hypertension for millions of patients world-wide. Accordingly, ReCor is committed to conduct rigorous, randomized, controlled studies to demonstrate the safety and efficacy of the Paradise system to lower blood pressure, thus helping physicians to evaluate how, in whom, and when to use Paradise for the treatment of hypertension.”

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Saranas raises $3m in Series C to support Early Bird bleed monitor

Internal bleeding detection device developer Saranas said today it raised $2.8 million in a Series C funding round slated to support its Early Bird bleeding monitor system.

The Early bird device is designed as a standard vascular access sheath which is embedded with sensors which detect bleeding from accidentally ruptured blood vessels during cardiac procedures, including transcatheter aortic valve replacements, the Houston, Texas-based company said.

Funds from the round will be used to support a multicenter clinical pilot trial of the Early Bird system in the US, as well as the company’s continued commercialization plan.

“We are pleased to bring additional investment and appreciate the confidence shown by so many returning investors. We continue our work to deliver a product to market that has the potential to significantly reduce bleeding complications while reducing related costs to providers and the healthcare system. Since our last round of financing, we have completed design verification and validation activities, continued to build our growing intellectual property portfolio, and submitted a De Novo application to the FDA. With this investment, we are well positioned to initiate a multicenter clinical pilot and extend access to this innovative device to patients in the U.S.,” prez & CEO Zaffer Syed said in a press release.

Saranas did not announce any participants in the round.

Late last month, Saranas said that it submitted an FDA application seeking de novo classification for its Early Bird bleed monitoring system.

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Cook Medical wins FDA de novo nod for Hemospray

Cook Medical said yesterday it won FDA de novo clearance for its Hemospray endoscopic hemostat designed for treating bleeding in the gastrointestinal tract.

The Hemospray product won indications from the FDA for treating non-variceal GI bleeds, the Bloomington, Ind.-based company said. Hemospray is a single-use device designed to deliver an aerosolized spray of a mineral blend to a bleeding site during endoscopic procedures, and can cover large areas including ulcers and tumors, according to an FDA release.

“We are extremely pleased to receive this approval to market from FDA. We have worked diligently to bring a different approach to hemostasis for gastroenterology teams across the United States,” Cook Medical endoscopy VP Barry Slowey said in a prepared release.

“Hemospray gives clinicians another tool for the care of their patients. Patients have been our number one priority for over 50 years and we’ve worked hard to bring this innovation to the field of gastroenterology across the U.S.,” Cook Medical MedSurg VP DJ Sirota said in prepared remarks.

The Hemospray powder is intended to absorb the water in blood to form a gel which acts both cohesively and adhesively to create a barrier to the bleeding site, Cook Medical said.

In its approval, the FDA said it reviewed data from studies of 228 patients with upper and lower GI bleeding alongside real-world evidence from medical literature reports which included data on an additional 522 patients. The Hemospray device was found to have stopped GI bleeding in 95% of patietns within 5 minutes of device usage.

The FDA said that 20% of patients experienced rebleeding between 72 hours and 30 days, and bowel perforations were observed in 1% of patients.

“The device provides an additional, non-surgical option for treating upper and lower GI bleeding in certain patients, and may help reduce the risk of death from a GI bleed for many patients,” FDA Center for Devices and Radiological Health surgical devices division director Dr. Binita Ashar said in a press release.

Early last month, Cook Medical said it re-launched its Beacon Tip Torcon NB advantage catheters in the US and Canada, after having recalled the devices due to complaints related to device tips on the items degrading and fracturing.

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Haemonetics swings to black for fiscal Q4, 2018

Haemonetics (NYSE:HAE) eked out a sales-and-earnings beat with its fiscal fourth-quarter and 2018 numbers today, posting swings to black ink for both periods.

The Braintree, Mass.-based blood management company reported profits of $11.9 million, or 22¢ per share, on sales of $233.6 million for the three months ended March 31, compared with losses of -$51.1 million during the same period last year; sales grew 2.4% over fiscal Q4 2017.

Adjusted to exclude one-time items, earnings per share were 43¢, a penny ahead of Wall Street, where analysts were looking for sales of $227.1 million.

Full-year profits were $45.6 million, or 85¢ per share, on sales growth of 2.0% to $903.9 million, compared with losses of -$26.3 million for fiscal 2017. Adjusted EPS were $1.87, dead even with The Street, where analysts forecast revenues of $898.0 million.

“In fiscal 2018, we focused on reorganizing and transforming our company. We launched our complexity reduction initiative, strengthened our talent base and received key regulatory clearances in our plasma business. Our performance exceeded our initial expectations, growing adjusted earnings per share 22% and free cash flow before restructuring and turnaround 43% on constant-currency revenue growth of 1%. We enter fiscal 2019 with confidence in our planned product launches and company-wide productivity efforts, and we are poised for accelerated growth,” CEO Chris Simon said in prepared remarks.

Haemonetics said it expedited its $260 million stock buyback with a $100 million, 1.2-million-share repurchase in February; by the time it closed yesterday, some 1.4 million shares were bought back.

The company said it expects to report adjusted EPS of $2.00 to $2.30 on constant-currency sales growth of 3% to 5% for fiscal 2019.

HAE shares were up 1.1% to $78.89 apiece today in early trading.

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LimFlow raises $34m in Series C round

LimFlow said today it raised $33.5 million (EU €27 million) in an oversubscribed Series C round of financing to support its technology designed to treat critical limb ischemia.

The round was led by Sofinnova Partners and joined by existing investors BpiFrance and Balestier, the Paris-based company said. As part of the funding round, Sofinnova venture partner Gérard Hascöet and Soffinova Crossover I fund partner Dr. Kinam Hong will join LimFlow’s board of directors.

“LimFlow is an excellent fit for our healthcare Crossover I fund, where we seek investments in companies with game-changing technologies that address important clinical unmet needs and are led by experienced and passionate management teams,” Dr. Hong said in a prepared statement.

Funds raised in the round will help support the company’s strategic initiatives through the second half of 2020 including the completion of the US pivotal trial of the LimFlow percutaneous deep vein arterialization system and future international commercialization.

LimFlow is developing the pDVA system, which is designed to restore perfusion to ischemic feet to relieve resting pain, promote chronic wound healing, reduce amputations and restore mobility. The device uses ultrasound-guided catheters and covered nitinol stents to bypass diseased arteries and divert blood flow to the tibial vein to vascularize the affected feet.

“We are gratified with the support we have received from Sofinnova Partners, a leading European venture capital firm and one of the most respected and specialized global Life Sciences investors. We are equally appreciative of the continued strong commitment from our existing investors. The new funds will enable us to continue our mission to save patients from amputation, and ultimately, save lives that might otherwise be lost,” LimFlow CEO Dan Rose said in a press release.

In March, LimFlow CEO Rose spoke to MassDevice.com about his hopes that the pDVA device will provide an opportunity to critical limb ischemia patients in the US who are facing amputations and no other options.

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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.

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

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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

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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

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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

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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.