InspireMD wins regulatory nod in Ecuador for CGuard, MGuard

InspireMD (NYSE:NSPR) said this week it won regulatory approval in Ecuador for its CGuard embolic prevention system and MGuard Prime devices.

The approval comes shortly after the company inked an exclusive distribution agreement with Ecuadorian medical device distributor Cardiobene, Israel-based InspireMD said. Both companies have worked together to secure regulatory approvals in the country, InspireMD added.

“We have been working with key opinion leaders as well as the top hospitals in the country in anticipation of these approvals in order to start selling the products. The clinical advantages for both of these products is compelling and we expect our physicians to start using the products very quickly,” Cardiobene’s Patricio Erazo said in a press release.

Sale of both devices is slated to begin immediately, InspireMD said.

“This approval enhances our footprint across Latin America. We are very excited to work with Cardiobene, one of the most successful distributors of endovascular products in Ecuador,” InspireMD chief commercial officer Agustin Gago said in a prepared statement.

In late March, InspireMD said it won regulatory approval from Peru’s Ministry of Health for its CGuard embolic prevention system and MGuard Prime.

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Teleflex launches TrapLiner cath in the EU

Teleflex (NYSE:TFX) said yesterday it launched the TrapLiner catheter, designed for use in vascular procedures, in Europe.

The Wayne, Penn.-based company said that its TrapLiner cath is similar in design to its GuideLiner V3 cath but also features an integrated balloon for trapping standard 0.014″ guidewires within a guide catheter.

The newly launched TrapLiner catheter is designed to operate as an alternative method to the trapping technique which requires the use of a PTCA balloon to exchange an existing over-the-wire catheter while maintaining guidewire position, Teleflex said.

The catheter is intended for use alongside guide catheters to access regions of the coronary or peripheral vasculature and to aid in placing interventional devices and for the exchange of interventional devices while maintaining the guidewire position, according to a press release.

Earlier this month, Teleflex posted first quarter earnings that beat the consensus on Wall Street and announced a manufacturing consolidation plan it hops will save $25 million to $30 million annually.

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SurModics acquires Embolitech thrombectomy tech for $5m

SurModics (NSDQ:SRDX) said today it inked a deal with Embolitech to acquire its thrombectomy platform the and associated intellectual property in a deal worth $5 million up front, with additional payments based on regulatory milestones.

The newly acquired tech platform is designed for use in the peripheral vasculature to remove hard blood clots, Eden Prairie, Minn.-based SurModics said. SurModics added that it plans to leverage its design, development and manufacturing capabilities to advance the platform into different peripheral and vascular applications.

“We are pleased to sign an agreement with Surmodics for this promising thrombus management platform that complements their current portfolio and aligns well with their focus on advancing therapies for peripheral artery disease,” Embolitech founder & chief medical officer Dr. Gary Ansel said in a prepared release.

“Surmodics’ proven expertise and leadership in key capabilities necessary for the future development of this technology, including advances in catheter delivery and surface technologies, makes it the ideal partner for Embolitech,” Embolitech CEO Ron Ginor said in a prepared statement.

SurModics said it expects to record a 49¢ per share charge to earnings during its third quarter of the fiscal year 2018 related to in-process R&D expenses and deal costs.

“We are excited to add to our portfolio a technology that offers significant advances over the current treatment of complex, peripheral artery disease. The Embolitech technology offers next-generation innovation that may eliminate the need for the use of thrombolytics, reducing the likelihood of ICU time and bleeding complications that significantly affect patient recovery and outcomes. In addition, the technology is anticipated to reduce procedure time and the need for multiple procedures, and it does not require any additional, external capital equipment,” SurModics prez & CEO Gary Maharaj said in a press release.

Last month, SurModics said it won FDA 510(k) clearance for its .018″ low-profile percutaneous transluminal angioplasty balloon dilation catheter designed for peripheral vascular use.

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J&J’s Biosense Webster launches Carto Vizigo guiding sheath

Johnson & Johnson’s (NYSE:JNJBiosense Webster said yesterday launched its Carto Vizigo bi-directional guiding sheath designed for use with the company’s Carto 3 system in the US.

The Irvine, Calif.-based division said that the sheath is designed for use with the Carto 3 system during catheter ablation procedures to aid electrophysiologists in reducing fluoroscopy dependency and to reduce radiation exposure.

“We are committed to developing novel technologies and workflows for EPs to reduce their exposure to radiation and help them gain freedom from the orthopedic burden of lead. The Vizigo sheath represents the next step in optimizing the Carto 3 System experience and enhancing the benefits our customers can reap from our integrated platform of technologies,” J&J medical devices cardiovascular and specialty solutions group chair Shlomi Nachman said in a press release.

The newly launched Carto Vizigo can be visualized on the Carto3 system map during ablation procedures, which the company said eliminates the need to solely use fluoroscopy to track its location.

The system has already been used in its first commercial procedures at the Massachusetts General Hospital in Boston, Biosense Webster said.

“We are always looking for ways to improve the care we deliver to our patients. One of our overall goals is to reduce dependency on fluoroscopy and gain more directional control and awareness during procedures,” MGH atrial fibrillation program director Dr. Moussa Mansour said in a prepared statement.

Last week, Biosense Webster said that it launched a European trial of its Qdot Micro novel radiofrequency ablation catheter designed for treating paroxysmal atrial fibrillation.

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Acutus Medical launches AcQMap cardiac mapping tech in US

Acutus Medical said today it launched the AcQMap high-resolution imaging & mapping system and the 3D mapping catheter that goes by the same name, touting that the system had been used in its first commercial procedures.

The Carlsbad, Calif.-based company said that AcQMap system is designed to detect and display standard voltage-based and higher resolution charge-source maps, and is able to generate real-time, 3D images of the heart chamber using ultrasound.

“Enabling physicians to see complex, irregular arrhythmias in real-time should provide important new insights and enable truly personalized and individualized ablation therapy planning.  We hope that this unique capability, combined with the ability to quickly re-map after each ablation, will lead the way to further improvements in clinical outcomes for patients suffering from complex arrhythmias. Together with institutions across the country, we hope to transform the lives of people suffering from complex arrhythmias through our innovative technology and are pleased that U.S. patients now have access to AcQMap,” prez & CEO Vince Burgess said in a press release.

Acutus Medical said that it has also launched a clinical study of the device exploring its use during atrial fibrillation retreatment ablation procedures.

Last October, Acutus Medical said that it won 510(k) clearance from the FDA for its AcQMap system. The system won CE Mark approval in the European Union in May 2016.

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CardioFocus wins FDA nod for HeartLight AF balloon

CardioFocus said today it won FDA approval for its HeartLight Excalibur balloon designed to treat paroxysmal atrial fibrillation.

The Marlborough, Mass.-based company said that the newly cleared balloon uses technology from its HeartLight endoscopic ablation system alongside a new feature set intended to improve speed and magnitude of tissue contact during pulmonary vein isolation procedures.

“We have seen encouraging results with the Excalibur Balloon. It obtains an impressive antral position and establishes even more tissue contact, which enables contiguous lesion sets. This is a clear advance in the field of balloon-based AF ablation, delivering on the promise of an ultra-compliant balloon,” Dr. Vivek Reddy of Mount Sinai’s Icahn School of Medicine said in a press release.

The Excalibur balloon also features CardioFocus’ dynamic response technology which allows for the operator to make real-time adjustments to balloon size to improve optimal tissue contact, which the company claims maximizes engagement of the balloon with pulmonary veins and decreases ablation procedure time.

“The FDA approval of the Excalibur Balloon is a significant milestone for CardioFocus, as it is the first ultra-compliant balloon introduced into the US market for AF ablation. The Excalibur Balloon capitalizes on the existing features of our HeartLight System, which offer an accurate, consistent, and controlled treatment option for PAF patients whose atrial arrhythmias are insufficiently controlled with medication,” COO Burke Barrett said in a prepared statement.

The Excalibur balloon won CE Mark approval in the European Union last September, and the company has since commercially launched the device in the region.

CardioFocus said it expects to being a full commercial launch of the device in the US during the third quarter of this year.

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J&J’s BioSense Webster launches Qdot Micro afib ablation cath trial

Johnson & Johnson’s (NYSE:JNJBiosense Webster said yesterday it launched a European trial of its Qdot Micro novel radiofrequency ablation catheter designed for treating paroxysmal atrial fibrillation.

The Irvine, Calif.-based division said that the first patient in the trial has already been enrolled and treated by Aalst, Belgium’s OLV Hospital.

“The concept of high power, short duration ablation is novel and a potentially groundbreaking advancement for the industry. This new modality could result in improvements in clinical outcomes and procedural efficiencies and I look forward to further investigation,” Dr. Tom De Potter of OLV Hospital said in a prepared statement.

In the Qdot AF study, researchers will examine the delivery of high power, short duration ablation with the Qdot Micro at eight European centers, expecting to enroll a total of 50 patients.

The Qdot Micro is a next-gen cath designed to treat AF in catheter ablation procedures, and can deliver 90 watts of RF power in a four-second temperature-controlled catheter ablation session, the company said. The catheter features optimized temperature control and micro-electrode technology for efficient and consistent lesion creation, the company claims.

The steerable, multi-electrode catheter is only available for investigational use in Europe, BioSense Webster said.

“Qdot Micro will be a significant advancement in catheter ablation technology that has the potential to elevate the standard of care for atrial fibrillation treatment. Biosense Webster has a legacy of leadership in cardiac ablation and we are excited by the prospects this new device may provide for millions of patients,” J&J medical devices cardiovascular and specialty solutions grouop chair Shlomi Nachman said in a press release.

In January, BioSense Webster said that the first patient has been enrolled in an investigational device exemption trial for its WaveCrest system.

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Abbott wins FDA nod for Advisor HD Gridcardiac mapping cath

Abbott (NYSE:ABT) said today it won FDA clearance for is Advisor HD Grid mapping sensor enabled catheter designed for creating highly detailed maps of the heart.

The newly cleared mapping catheter builds on the Abbott Park, Ill.-based company’s previous designs and and is intended to improve cardiac ablation procedures by providing an inside view of the heart for more accurate identification of the cardiac anatomy.

The Advisor HD Grid catheter is designed to capture data including the direction and speed of cardiac signals, and allows for the creation of high-density maps of cardiac tissue for more optimal treatment regimens, Abbott said.

The catheter’s sensor enabled technology can also improve accuracy of the cardiac image when paired with the company’s EnSite Precision cardiac mapping system, Abbott said.

“At the University of Chicago Medicine, we are passionate about understanding and redefining arrhythmia mechanisms with higher resolution cardiac mapping. Abbott’s Advisor HD Grid represents an important step in the development of next generation mapping catheters. With a flexible and soft design using magnetic sensor technology, the catheter helps capture signals previous catheters may have missed to support the creation of highly detailed 3D maps of the heart. Innovation within the field of electrophysiology continues to evolve toward improving our ability to visualize arrhythmias in much greater detail, and we are confident that patient outcomes will improve as a result,” Dr. Roderick Tung if the University of Chicago Hospitals said in a prepared statement.

The Advisor HD Grid mapping catheter won CE Mark approval last December, the company said.

“The goal in developing the Advisor HD Grid mapping catheter, sensor enabled was to provide physicians with an innovative solution to quickly and accurately map complex arrhythmias in patients,” Abbott electrophysiology biz medical director Dr. Srijoy Mahapatra said in a press release.

Last month, a post-approval registry study of Abbott’s MitraClip mitral valve repair device showed positive results at one year, according to late-breaking results presented at the annual meeting of the Society for Cardiovascular Angiography & Interventions in San Diego.

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10 BIOMEDevice Boston exhibitors you need to know

BIOMEDevice Boston is an opportunity for more than 4,000 engineers and executives and 400 suppliers in New England’s design and manufacturing industry to connect and network. The annual event is being held at the Boston Convention and Exhibition Center, April 18-19.

Hundreds of supplier booths will be showcasing their latest technologies and capabilities. Here are 10 companies that are exhibiting at BIOMEDevice Boston that you should know.

Next >>

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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.