Study: Catheter thrombolysis doesn’t lower risk of post-thrombotic syndrome, raises bleeding risk

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thrombolysisA study of catheter-guided thrombolysis in patients with deep-vein thrombosis found no reduction in risk for post-thrombotic syndrome but a higher risk of major bleeding.

The study, published in the New England Journal of Medicine, examined 692 patients with acute proximal deep-vein thrombosis, randomized to receive either anticoagulation drugs alone or anticoagulation plus pharmaco-mechanical thrombolysis. The experimental arm was treated with the intra-thrombus delivery of recombinant tissue plasminogen activator and thrombus aspiration or maceration, with or without stenting. The primary outcome was development of PTS between 6 and 24 months.

The researchers found no significant difference between the groups in terms of PTS, which was found in 47% of the experimental cohort and in 48% of the control group. But there were more major bleeding events in the interventional arm within 10 days (1.7% vs. 0.3%).

However, there were no significant differences in recurrent venous thromboembolism over two yaers, with 12% occurring in the pharmaco-mechanical-thrombolysis group and 8% in the control group. Moderate-to-severe PTS occurred in 18% of patients in the treatment arm versus 24% in the control group.

Severity scores for PTS were lower in the interventional group than in the control group at 6, 12, 18, and 24 months, but “the improvement in quality of life from baseline to 24 months did not differ significantly between the treatment groups,” the study found.

“Among patients with acute proximal deep-vein thrombosis, the addition of pharmaco-mechanical catheter-directed thrombolysis to anticoagulation did not result in a lower risk of the post-thrombotic syndrome but did result in a higher risk of major bleeding,” the authors wrote.

NanoVibronix touts lowered UTIs in interim UroShield study results

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NanoVibronix

NanoVibronix (NSDQ:NAOV) today released interim results from a trial of its UroShield ultrasound device designed to prevent bacteria and biofilms from forming on urinary catheters, touting a low rate of catheter-acquired urinary tract infections.

The Uroshield device from the Elmsford, N.Y.-based company is designed to decrease pain and discomfort associated with urinary catheter use while also preventing bacterial colonization and biofilm on indwelling catheters to reduce UTIs.

The 51-patient trial examined patients at 5 nursing facilities, with 26 patients being treated with the UroShield and 25 in a control group receiving the standard of care. All patients in the trial had been treated for at least 1 incident of CAUTIs requiring antibiotics 6-months prior to the trial, the company said.

At 90-days, 52% of the control group individuals had developed a CAUTI which required antibiotic intervention, while only 4% of the UroShield patients acquired one.

All subjects were initially recorded with a colony count of greater 100,000 CFU cultured from their urinary tract, NanoVibronix said. UroShield patients showed reductions in this count, however, with 15 patients having counts reduced to 10,000 CFU at 90 days and 10 patients reduced to 1,000 CFU.

“We are pleased to report the interim results of this latest study, demonstrating a material reduction in the rate of CAUTI. These successful results reinforce our earlier data demonstrating a significant reduction in infection rates and bacterial colonization on catheter devices when using UroShield. We believe that the fact that UroShield already has European and Canadian marketing clearance, a strong safety profile including our predicate devices, as well as strong data from this and other ongoing studies, should help to accelerate 510(k) marketing clearance with the United States Food and Drug Administration. We also plan to use this evidence to bolster our European and Canadian marketing efforts while working through the FDA application, and plan to start developing a distribution network in the U.S. in advance of marketing clearance. The reduction in the rate of CAUTI further illustrates the potential to reduce healthcare costs, improve outcomes, and enhance quality of life for patients. We are very encouraged by the outlook for this product, as we are not aware of any other local device that has demonstrated this type of short-term and long-term prevention of CAUTI in the catheterized patient population,” CEO Brian Murphy said in a press release.

Yesterday, NanoVibronix said it pulled down more than $5 million from a public stock offering for its Surface Acoustic Wave antimicrobial platform.

Medtronic, Boston Scientific, St. Jude Medical escape catheter patent suit

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gavelA trio of medical device companies yesterday escaped a patent infringement lawsuit filed by the inventor of a catheter after a federal judge in Wisconsin ruled that the case was filed in the wrong jurisdiction.

Imran Niazi in April sued Medtronic (NYSE:MDT), Boston Scientific (NYSE:BSX) and Abbott (NYSE:ABT) subsidiary St. Jude Medical in the U.S. District Court for Western Wisconsin, alleging infringement of U.S patent 6,638,268 covering a coronary sinus catheter.

The companies moved to dismiss the case, arguing that it lacked jurisdiction in light of the U.S. Supreme Court decision in TC Heartland v. Kraft Foods Group Brands, which limited the ability of patent holders to sue in other states.

Yesterday Judge James Peterson found for the defendants based on the Heartland ruling, according to court documents.

“In these cases, it is undisputed that none of the defendants are incorporated in Wisconsin, so none of them ‘reside’ here. As to the second option for establishing proper venue, some of the defendants admit that they sell accused products in this district and some deny that they do, but all of the defendants deny that they have ‘a regular and established place of business’ in the district, so the court will focus on that issue,” Peterson wrote. “In light of the absence of any evidence or even allegations from Niazi that any of the defendants have a regular and established place of business in this district, the court concludes that Niazi has failed to show that venue is proper here.”

Peterson also ruled against allowing Niazi to proceed with discovery to prove residence in the western Wisconsin district, according to the documents.

“In these cases, Niazi has not identified any basis for believing that discovery will show that any of the defendants have a place of business in this district. Even if the court assumes as Niazi suggests that some of the sales people might keep some inventory at their homes, that type of de minimis evidence would not be sufficient to show that a defendant engaged in business from the employees’ homes,” he wrote. “To avoid questions about jurisdiction after a transfer, the court will dismiss the cases so that Niazi and the assignee can refile after determining the proper parties.”

Japan clears Abbott’s Mitraclip

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Abbott's Mitraclip

Abbott (NYSE:ABT) said today it won approval from Japan’s Ministry of Health, Labour and Welfare for its MitraClip transcatheter mitral valve repair device, cleared for indications of treating people with mitral regurgitation.

Currently, standard of care treatment for mitral regurgitation in Japan is limited to open-heart surgery and medication, Abbott said. Clearance of the catheter-based MitraClip system adds a minimally-invasive treatment option not previously available in the region, the company added.

The MitraClip is designed to be delivered to the heart through a blood vessel in the leg, securing portions of the leaflets of the mitral valve with a clip to allow the heart to pump blood more efficiently through the body.

“It is our mission to help people suffering from structural heart disease return to better health and quality-of-life by providing technologies and therapies that advance how people are treated. With the approval of our revolutionary MitraClip device in Japan, we can help more people live better by reducing the severity of their extremely life-altering illness in a safe and predictable way,” structural heart biz VP Michael Dale said in a press release.

Approval in Japan came based on data from the AVJ-514 clinical trial in the region, which reported an 86.7% rate of 2+ or less mitral regurgitation and classified 96.7% of patients as NYHA class I or II with no major adverse events at 30 days.

“MitraClip provides a new treatment option for many people with severe mitral regurgitation who cannot undergo the mitral valve surgery. The introduction of MitraClip therapy in Japan will help more people who previously had limited options return to better health faster, with dramatically reduced symptoms,” trial principal investigator Dr. Kentaro Hayashida of Tokyo’s Keio University said in a press release.

Last week, Abbott said it won’t introduce its next-generation drug-eluting stent, the Xience Sierra, to the Indian market due to price caps there.

InterRad Medical raises another $5m for SecuraCath

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Interrad MedicalInterrad Medical last week reported raising another $5 million for its SecuraCath device, saying it hopes to raise $2 million more.

SecurAcath is designed with small insertable anchors at the point of catheter entry to keep catheters from moving or coming loose in patients. The attachment device eliminates the need to suture or adhesively attach catheters. The device won 510(k) clearance from the FDA in 2010.

The most recent debt funding, revealed in an Oct. 26 filing with the U.S. Securities & Exchange Commission, adds to the $10 million Series C round the Plymouth, Minn.-based company raised in 2011. Another $7.5 million raise followed in 2014.

In 2015 the company landed a Federal Supply Schedule contract with U.S. Veterans Affairs Dept. and Defense Dept. hospitals for SecurAcath.

FDA clears Nitiloop’s Nova Cross micro-catheters

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NitiloopIsraeli medical device maker Nitiloop said today that it won 510(k) clearance from the FDA for a pair of its micro-catheters.

Netanya, Israel-based Nitiloop said the federal safety watchdog cleared its Nova Cross Extreme coronary micro-catheter and its Nova Cross BTK peripheral device.

“We are very excited at receiving FDA clearance for the Nova Cross Extreme and Nova Cross BTK, which further establishes our Nova Cross product family. We are encouraged by the positive medical community response to our new products bringing solution to one of the last un-met clinical need in the cath lab,” CEO Chana Schneider said in prepared remarks.

“With the continuing rise in CAD prevalence and increasing complexity of lesions requiring recanalization, the Nova Cross Extreme is a significant new addition to our tool box for tackling these lesions,” added Dr. William Nicholsonof Pennsylvania’s  York Hospital.

Nitiloop said it recently closed a 145-patient pivotal study of another micro-catheter, the NovaCross CTO, designed to cross chronic total occlusions in coronary arteries.

“The company submitted study results and is expecting FDA feedback within the next weeks,” Nitiloop said.

Medtronic launches pivotal trial of Intrepid TMVR system

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Medtronic logo

Medtronic (NYSE:MDT) said today it launched a pivotal trial of its Intrepid transcatheter mitral valve replacement system after winning FDA investigational device exemption for the device.

The 1st patient in the trial was enrolled at Milwaukee’s Aurora St. Luke’s Medical Center, the Fridley, Minn.-based company said.

The Apollo trial is slated to enroll up to 1,200 patients with severe, symptomatic mitral valve regurgitation into 2 cohorts with a primary endpoint of composite of all-cause mortality, all-stroke, reoperation or reintervention and cardiovascular hospitalization at 1 year.

Secondary endpoints in the trial include quality of life measures and valve performance in patients with severe symptomatic mitral regurgitation.

“This is the beginning of an important journey to establish a truly less invasive approach to treat severe mitral valve regurgitation in patients who are appropriate candidates for mitral valve replacement with a transcatheter technology that eliminates the need for open-heart surgery,” trial co-principal investigator Dr. David Adams of Mount Sinai Health System said in a prepared statement.

The trial will examine patients in 2 cohorts, split between 650 patients who are candidates for conventional open-heart mitral valve replacement surgery and not eligible for mitral repair and 550 patients who are too high risk for open-heart mitral valve surgery.

Patients in the 1st cohort will be randomized to either receive the Intrepid TMVR system or a conventional mitral valve surgery, with a primary endpoint to demonstrate the Intrepid’s non-inferiority to conventional surgery at 1 year. The 2nd cohort’s primary endpoint is designed to demonstrate statistical non-inferiority to a performance goal at 1 year, Medtronic said.

“We worked closely with the FDA and leading physicians to design a trial that will compare the Intrepid TMVR system with the current standard of care for patients with mitral regurgitation. We are excited to investigate whether this technology holds promise for the large number patients suffering from the debilitating symptoms of severe mitral regurgitation,” Medtronic coronary & structural heart division prez Sean Salmon said in a prepared release.

The Intrepid system features self-expanding, dual-stent technology and a replacement tissue heart valve to allow for catheter-based implantation. The valve is compressed inside a hollow delivery catheter inserted between the ribs to enter the heart and is expanded directly into the malfunctioning mitral valve, the company said. The outer stent is designed to attach and conform to the native valve without sutures or anchors while the inner stent houses the valve, made from bovine tissue.

“The Intrepid system features a truly innovative dual-stent design and the trial will investigate its safety and efficacy in addressing severe symptomatic mitral regurgitation replacing the need for an open-heart procedure. We look forward to working with the APOLLO Trial clinical sites in the U.S. and around the world,” trial co-principal investigator Dr. Martin Leon of Columbia University Medical Center/New York-Presbyterian Hospital said in a prepared statement.

Earlier this month, Medtronic said it won expanded FDA approval for its Endurant II and IIs stent graft systems designed to treat abdominal aortic aneurysms, now indicated for use in combination with the Heli-FX EndoAnchor system to treat patients with short, hostile aortic neck anatomies.

Boston Scientific to acquire Apama Medical in deal worth up to $300m

Boston Scientific, Apama Medical

Boston Scientific (NYSE:BSX) said today it inked a deal worth up to $300 million to acquire Apama Medical and its radiofrequency balloon catheter system designed to treat atrial fibrillation.

The deal includes an initial $175 million in cash up-front from Marlborough, Mass.-based Boston Scientific and an additional $125 million in contingent payments between 2018 and 2020 based on clinical and regulatory milestones. Boston Scientific expects the acquisition to close the 4th quarter of 2017.

Campbell, Calif.-based Apama’s novel RF balloon is a single-shot, multi-electrode device designed to combine the benefits of RF point-by-point and balloon-based ablation approaches, the company said, claiming the system delivers differentiated energy levels and shorter procedure times.

The system features an incorporated digital camera with LED lights and sensing electrodes for real-time visualization of the procedure and catheter electrode contact.

“The acquisition of Apama further advances our continued investment in the electrophysiology category, and, upon commercialization, would broaden our portfolio of differentiated arrhythmia solutions. We are also excited about the ability to integrate the Apama RF balloon system with our Rhythmia HDx mapping system to provide physicians with an unprecedented visualization of the heart during ablation procedures,” Boston Scientific rhythm management prez Joe Fitzgerald said in a prepared statement.

Results from the 1st-in-human study of the device showed the Apama RF balloon met safety and efficacy endpoints and achieved successful pulmonary vein isolation in treating paroxysmal AF patients.

“Study results reinforce the Apama RF balloon is an advancement in single-shot technology for PVI and can provide physicians with greater control and efficiency when performing AF ablations. We look forward to continuing the development and commercialization of this novel ablation solution to treat both paroxysmal and persistent AF,” Boston Scientific rhythm management and global health policy chief medical officer Dr. Kenneth Stein said in a press release.

The Apama RF balloon is currently being studied in clinical trials in Europe as the company looks to achieve CE Mark approval, which it hopes to receive in late 2018.

Boston Scientific said the acquisition is expected to be immaterial to its adjusted earnings per share for 2017 and 2018, and more dilutive on a GAAP basis due to amoritization expense, transaction and integration related costs.

Last November, Apama Medical said it raised a total of $19.7 million, with $13.2 million coming from a closed Series C round and $6.5 million from a debt facility with Silicon Valley Bank.

The post Boston Scientific to acquire Apama Medical in deal worth up to $300m appeared first on MassDevice.

Anaconda Biomed raises $17m for next-gen brain thrombectomy device

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Anaconda BiomedAnaconda Biomed said it raised nearly $17 million (€15 million) in a Series A round for the neurothrombectomy device it’s developing.

The round, led by new investors Ysios Capital, Omega Funds and Banco Sabadell and prior backer Innogest Capital, is enough to carry the ANCD Brain device through validation & verification and clinical studies ahead of a CE Mark bid in the European Union, co-founder & CEO Ofir Arad said in prepared remarks.

The proceeds are also earmarked for an initial approval submission to the FDA, Arad said. Ysios general partner Josep Sanfeliu and Omega Funds managing director Claudio Nessi joined Barcelona-based Ananconda’s board in connection with the Series A round, the company said.

“This financing provides Anaconda Biomed  the capital necessary to substantially progress the development of our ANCD Brain device, including the validation and verification process, clinical studies to support the initial commercialization of ANCD Brain  in Europe, and an initial submission to FDA,” Arad said. “Furthermore, the addition of Josep and Claudio to our board will strengthen the extensive operational and financial expertise available to our management team.”

“The investment in Anaconda Biomed is great news not only for the consolidation of the medtech ecosystem in Spain and Barcelona but also for the amazing work of the founders in putting together a disruptive medical device by combining excellent medicine with high tech chemistry,” Sanfeliu added.

“We are very pleased for this sizable investment round following our first seed investment in Anaconda Biomed 1 year ago,” Innogest partner Claudio Rumazza said in a statement. “With its innovative design addressing a clear clinical need and a capable management team, Anaconda Biomed is well positioned to be a winner in the high growth stroke treatment market and a success story for European medtech industry”.

“Mechanical thrombectomy is quickly becoming a game changing procedure for ischemic stroke patients,” Nessi said. “Our analysis suggests that Anaconda’s innovative device may become the next generation device and therefore a market leader.”

Anaconda last month tapped Creganna Medical as its development partner for the ANCD Brain device.

($1 = €0.888797)

QT Vascular raises $14m

QT Vascular

QT Vascular said this week it inked a private placement deal with Gem Global Yield Fund for up to $14.3 million (SGD $20 million) over the next 30 months.

In the funding agreement, Singapore-based QT Vascular will receive up to $7.2 million (SGD $10 million) over the next 30 months, with an option for an additional $7.2 million on identical terms to the original agreement. The option is available for a period of 6 months, the company said.

Funds are slated to support repaying existing debt, improve cash flow and increase production to support its non-drug coated Chocolate PTA products.

“This agreement with GEM Global continues the momentum, started with winning the legal case with AngioScore Inc. last year, and then signing a distribution agreement with Medtronic last month. It gives QT Vascular some strong alternatives as it secures funding for continued growth and development of the Company over the next few years. This capital commitment places QT Vascular in a commanding position to continue with its business and strategic partnership plans, improve the Group’s cash flow and increase production to support market demand for our products,” QT Vascular CEO Eitan Konstantino said in a prepared statement.

QT Vascular said it also agreed to issue 35 million warrants to GEM Global, each with the right to subscribe to 1 new ordinary share in the company. The rights will be exercisable for 5 years at a fixed price of 7¢ per share (SGD 10¢).

In February, QT Vascular said it inked a definitive agreement with Medtronic (NYSE:MDT) to distribute QT’s Chocolate PTA catheter for 5-years.

The deal between QT Vascular and Fridley, Minn.-based Medtronic will be automatically renewable for 2 additional 1-year periods, and both companies will continue to negotiate other aspects of their relationship.