Medtronic backs infant-sized miniature pacer

Medtronic logo updated

Medtronic (NYSE:MDT) is collaborating with researchers at the Children’s National Health System to develop a miniature pacemaker intended for use with infants.

The prototype version of the device was presented at the American Heart Association’s 2018 Scientific Sessions by Dr. Rohan Kumthekar of the Sheikh Zayed Institute for Pediatric Surgical Innovation, part of the Children’s National Health System.

The newly developed miniature pacer is designed to be implanted through a 1 cm incision just below the ribcage, eliminating the need for open-chest surgery, according to a CNHS report.

The device is implanted with the help of a two-channel, self-anchoring access port which allows operators to insert a camera to directly visualize the procedure. A narrow sheath can then be inserted through the second channel to access the pericardial sac where the leadlet can be affixed to the surface of the heart.

The median time from incision to implantation in the thoracoscopic surgery study was 21 minutes, with the procedure taking less than an hour on average, much shorter than the average open-chest surgery which can take multiple hours.

Researchers think that the miniature pacers and approach may also aid in treating adult patients with limited vascular access.

“As cardiologists and pediatric surgeons, our goal is to put a child’s health and comfort first. Advancements in surgical fields are tending toward procedures that are less and less invasive. There are many laparoscopic surgeries in adults and children that used to be open surgeries, such as appendix and gall bladder removals. However, placing pacemaker leads on infants’ hearts has always been an open surgery. We are trying to bring those surgical advances into our field of pediatric cardiology to benefit our patients. The advantage is that the entire surgery is contained within a tiny 1-cm incision, which is what we find groundbreaking. Placing a pacemaker in a small child is different than operating on an adult, due to their small chest cavity and narrow blood vessels. By eliminating the need to cut through the sternum or the ribs and fully open the chest to implant a pacemaker, the current model, we can cut down on surgical time and help alleviate pain,” Kumthekar said in a prepared statement.

The miniature pacer has passed a proof-of-concept simulation and the experimental model is ready for the second phase of testing, which will aim to explore how the devices hold up over time.

“The concept of inserting a pacemaker with a 1-cm incision in less than an hour demonstrates the power of working with multidisciplinary research teams to quickly solve complex clinical challenges,” guiding study author Dr. Charles Berul of CNHS said in a press release.

Today, Medtronic said that it received CE Mark in the European union for its Valiant Navion thoracic stent graft system intended for use in minimally invasive procedures to repair lesions in the descending aorta.

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Abiomed shares slide despite Impella CP trial success


Abiomed (NSDQ:ABMD) shares fell approximately 13.1% yesterday despite the company announcing positive results from a pilot trial of its Impella CP heart pump that will clear the way for a pivotal that could nearly double the device’s total addressable market.

The company announced on Sunday that a pilot study of its Impella CP, used to unload the left ventricle for patients presenting with anterior ST-segment elevation myocardial infarction without cardiogenic shock met its primary endpoints and that it plans to launch a pivotal trial during the second half of next year.

Leerink Partner analyst Danielle Antalffy said that they expected that results from the trial might end up having a positive effect on the company’s shares, according to a letter to investors.

“While [Abiomed] shares have run in the last few days – +25% off recent lows – we do think investors will likely focus on these encouraging trends in infarct size, and shares could move moderately higher on this data,” Antalffy wrote in a letter on Sunday.

Abiomed saw its shares drop approximately 13.1% on Monday, opening at $388.99 and closing at $337.86. The drop was reportedly due to the high expectations of the company’s investors, according to another letter to investors from Antalffy released today.

“Despite the pilot trial’s success, [Abiomed] shares sold off yesterday, likely caused by: (1) Elevated investor expectations for more definitive positive trends favoring the unloading arm, which would have been incredibly difficult in such a small trial; (2) what may be perceived as a modest delay in initiation of the pivotal trial, with [Abiomed] targeting 2H19 vs 1H19; and (3) a broader selloff in MedTech, and specifically in growth/momentum stocks,” Antalffy wrote.

They went on to state that at its reduced price, shares in the company reflect “very little STEMI, which we peg to be nearly $140/share based on our DCF”.

If the pivotal trial of the device is successful, Abiomed could see a nearly double increase in its total addressable market, Antalffy said, who was bullish on the company’s efforts.

“With or without STEMI, we believe [Abiomed] has a monopoly in a large and under penetrated market that ultimately could prove to be multiples of its current size. More importantly, we believe the company will most likely revise its multi-year vision set at the 2015 analyst meeting – $1B+ in revenue from the current high risk PCI and cariogenic shock indications alone by FY2021 and ~30% operating margins – with the company clearly tracking ahead of this goal already on operating margins and pushing close to $1B insoles next year, based on our estimates,” Antalffy wrote in a letter to investors.

Shares in Abiomed have dropped a much smaller 0.3% today, at $336.72 as of 11:15 a.m. EST.

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Pilot trial of Abiomed’s Impella as heart attack treatment meets endpoints, pivotal to follow

Abiomed's Impella RP

A pilot trial exploring the use of Abiomed‘s (NSDQ:ABMD) Impella heart pump as a treatment for reducing the severity of heart attacks has met its primary safety and feasibility endpoints, clearing the way for a pivotal trial, according to primary investigator Dr. Navin Kapur.

Results from the pivotal, if successful, could “change the paradigm of heart attack management,” Kapur told in an interview.

Data from the pilot trial were announced today at the AHA Scientific Sessions 2018 in Chicago.

“We’ve now demonstrated for the first time that [left ventricle] unloading, using the ImpellaCP device with a 30 minute delay before reperfusion is safe and feasible,” Kapur said, commenting on the pilot trial. “What we also learned was that among patients who have larger heart attacks, there was a significantly lower infarct size.”

Even more importantly, the treatment could improve outcomes for heart failure patients.

“If we can change infarct size by 5%, we think that this will reduce the global burden of heart failure due to heart attacks and will also improve not only short term mortality, but improve long term mortality for patients who are coming in with a heart attack. And that’s really the central goal of both the pilot and the pivotal trial,” Kapur said.

For every 5% increase in heart damage after a heart attack, there’s a relative 20% increase in heart failure hospitalization at one year, and a 20% increase in mortality, Kapur said.

“There’s a significant need in public health for trying to reduce heart attack size for patients who are coming in, despite using contemporary approaches,” Kapur said.

Blocked arteries reduce the amount of oxygen supplied to the heart, Kapur said, so in normal treatment, opening the arteries to improve myocardial oxygenation has been a primary concern. But previous research has suggested that instead of simply restoring oxygen supply by opening arteries, myocardial oxygen demands could also be lowered through reperfusion, or reducing the work the heart has to do – with something like Abiomed’s Impella pump.

In his own research, Kapur said that he’s found that reperfusion works best with a 30 minute delay, leaving the device in and functioning while the arteries are blocked, before opening any arteries.

“We’ve spent the last six to eight years understanding the mechanism for why delayed reperfusion in the setting of an unloading pump seems to work. And there’s a number,” Kapur said.

Kapur and he and his team published research in the Journal of the American College of Cardiology in August exploring the mechanism, and that the pilot study aimed to explore the safety and feasibility of the technique.

In the pilot trial, dubbed The Door to Unload, researchers explored the mechanical benefit of delayed reperfusion in treating patients who suffered from a heart attack. Investigators enrolled a total of 50 patients, half of which received left ventricle unloading with the Impella followed by immediate reperfusion, while the other half received a 30 minute delay to reperfusion, Kapur said.

Safety endpoints in the trial included any increase in major adverse cardiovascular or cerebrovascular events and an increase in infarct size amongst those in the delayed reperfusion arm.

Results from the phase one safety and feasibility trial indicated a 100% successful implantation and unloading rate with the Impella, Kapur said.

Data indicated no significant difference the rate of major adverse cardiovascular or cerebrovascular events among arms, and found infarct size that was smaller than what was seen in previously published studies. Delaying reperfusion had no effect on infarct size either, Kapur said. Patients were examined at three to five days and thirty with cardiac magnetic resonance imaging, he added.

An additional analysis, which explored patients who experienced larger heart attacks, found that unloading and delayed reperfusion resulted in a statistically significantly lowered infarct size, normalized to the area of risk, as compared to unloading and immediate reperfusion.

“And the reason why this is important is because the purpose of the pilot was to inform the development of the pivotal study,” Kapur said.

The pivotal is slated to compare standard-of-care treatment, which takes into consideration only door-to-balloon time, against patients treated with delayed reperfusion using the Impella pump.

Kapur said he believes that results from the trial, if successful, could be disruptive, as it could suggest that unloading treatment with the Impella device is a therapy in itself.

Beyond the pivotal, Kapur said he sees a lot of opportunity to explore other angles, including other therapies or treatments to engage in during the 30 minute delay.

“What do you do during those 30 minutes? Do you give drugs that would potentially be more beneficial in reducing infarct size?” Kapur said.

Earlier this month, Abiomed posted fiscal second-quarter numbers that shredded the consensus forecast and raised its outlook on the rest of the year, sending share prices up sharply today.

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InCarda Therapeutics raises $42m for inhaled atrial fibrillation drug

InCarda Therapeutics logoInCarda Therapeutics said today that it raised $42 million in an oversubscribed Series B financing round led by Sofinnova and HealthCap.

Proceeds from the round are slated to support a Phase II trial of the company’s inhaled paroxysmal atrial fibrillation drug, InRhythm.

Get the full story at our sister site, Drug Delivery Business News.

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NeoChord raises $25m in Series D


NeoChord said yesterday it closed a $25 million Series D equity financing round to help support its mitral valve repair system intended to treat mitral valve regurgitation.

The round was led by U.S. Venture Partners, co-led by Deerfield Management and joined by Baird Capital, St. Louis Park, Minn.-based NeoChord said.

“NeoChord has established strong, clinical credibility with its current platform and has entrenched beating heart chordal repair as an important treatment option for the mitral toolbox. We are confident in the team’s ability to leverage their robust commercial experience in chordal repair with the current device while driving the development of their two transcatheter repair programs. We look forward to the collaboration with NeoChord to further advance treatment options for patients suffering from mitral valve regurgitation,” U.S. Venture Partners’ Casey Tansey said in a prepared statement.

As part of the funding round, Tansey will join NeoChord’s board of directors, the company said.

Proceeds from the funding round will be used accelerate development of the company’s transcatheter chordal repair and edge to edge programs, NeoChord said. The chordal repair system is used in a minimally invasive, echo-guided treatment for patients with mitral valve regurgitation.

“We are pleased to close the Series D financing to resource the acceleration of the on-going development of our transcatheter edge-to-edge and chordal repair programs. As the leader in chordal repair, we will continue our strong commercial presence internationally, while fast-tracking the development of our catheter-based programs.  We look forward to partnering with U.S. Venture Partners as we execute our core R&D and commercial strategies,” prez & CEO David Chung said in a press release.

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4Tech launches TriCinch coil system US feasibility study


4Tech said that it launched an FDA-approved U.S.-based early feasibility study of its TriCinch coil system intended to reduce tricuspid regurgitation,

The first two successful implantations of the device were performed at Atlanta’s Piedmont Heart Hospital by Dr. Christopher Meduri, Dr. Vivek Rajagopal and Dr. Mani Vannan, the Ireland-based company said.

“We are pleased to be the first center in the U.S. to implant the TriCinch Coil System. Both procedures went smoothly, and the device was easy to implant. Having a technology like the TriCinch Coil System in our structural heart toolkit allows us to treat a wide range of patients suffering from tricuspid regurgitation, who are at high risk for open heart surgery, in a safe and simple manner,” Dr. Meduri said in a prepared statement.

The TriCinch coil system is a percutaneous direct annuloplasty device designed to remodel the tricuspid valve through a nitinol coil anchor tensioned by a nitinol stent in the inferior vena cava.

The system is currently being evaluated in a CE Mark trial seeking clearance in the European Union, with enrollment in Australia and Europe.

“This is a major milestone for 4TECH, and I am excited with the progress the team has made. The TriCinch Coil System is designed to simply target the underlying pathology of annular dilatation. With this device, we are committed to helping patients who have very limited treatment options,” CEO Tom Fleming said in a press release.

“Through our experience and in collaboration with key physicians, we have built a robust clinical program to evaluate the safety and efficacy of the device. I am encouraged by our momentum, and I am confident that we will provide physicians with a novel solution that will benefit patients suffering from TR,” CMO Dr. Keith Dawkins said in a prepared statement.

In February, 4Tech said that it named a pair of Boston Scientific (NYSE:BSX) veterans as its new CEO and CMO, with onetime chief Mike Ennen stepping away for “family reasons.”

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Apple Watch study enrolls 400k participants

Apple Watch

An atrial fibrillation screening study using Apple‘s (NSDQ:AAPL) next-gen Apple Watch has enrolled 400,000 subjects, making it the largest study of its kind to date.

Enrollment for the Apple Heart trial has been completed by Stanford University’s School of Medicine, and the study rationale and design has already been published in the American Heart Journal.

“The advantage of the app that uses the optical sensor is that it can check for an irregular pulse multiple times throughout the day in the background, without needing the user to actively engage the application,” study principal investigator Marco Perez of Stanford’s Cardiovascular Medicine said in a prepared statement.

Investigators in the trial aim to explore whether wearable technology can successfully identify pulse irregularity, in hopes that it may be able to identify previously unknown atrial fibrillation. The watch analyzes pulse-rate data with an optical sensor, using LED lights and light-sensitive photodiodes to measure changes in the volume of blood flowing through the users wrist.

If atrial fibrillation is detected, participants will be alerted through a notification system on the Apple Watch or Apple Heart application. Subjects will then proceed through a telehealth video visit with a doctor and receive an electrocardiogram monitoring patch to confirm the AF diagnosis.

Any participants who experience urgent symptoms will be directed to their local urgent care or emergency room facilities.

“We now have access to high-quality sensors that can measure and detect changes in our bodies in entirely new and insightful ways without even needing to go to the doctor, but we need to rigorously evaluate them,” study principal investigator Mintu Turakhia of Stanford’s Cardiovascular Medicine said in a press release.

Last month, Zimmer Biomet (NYSE:ZBH) said that it launched a clinical trial using the Apple Watch to help hip and knee replacement patients that could enroll as many as 10,000 patients.

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FDA warns of battery shutdown issues with Getinge’s Maquet/Datascope IABPs


The FDA this week posted a letter to healthcare providers warning of reports that Getinge‘s (PINK:GETI BDatascope and Maquet  intra-aortic balloon pumps are shutting down while running on battery power, which could result in serious injury or death.

The company’s intra-aortic balloon pump is designed to be implanted in the descending aorta distal to the left subclavian artery. The system is intended to provide temporary support to the heart’s left ventricle using an electromechanical system to inflate and deflate the balloon, increasing coronary perfusion and reducing left ventricular work, the agency said.

The FDA said that it has received over 75 medical device reports of Maquet and Datascope IABP devices shutting down while running on battery, leading to pump stop and loss of hemodynamic support.

“Five of these reports described three patient deaths, although the deaths cannot be definitively attributed to the device shutting down. Other reports describe serious patient injury such as a sudden drop in blood pressure or the need for resuscitation. At least six reports indicated that there was no alarm warning before the device shutdown,” the FDA said in its letter.

The onset of the shutdowns range from immediately after disconnection of the device from AC power to within the expected battery lifespan, the federal watchdog said.

The FDA said that it also received reports describing non-shutdown battery issues, including the battery not charging, battery charge indicators not working and the battery depleting sooner than expected. The agency said that these issues could also lead to unexpected patient harm.

The root cause of the issue is not known, the federal watchdog said.

The FDA said that despite the issues, the devices “may be the best option for circulatory support for some patients,” and added that it was looking to raise awareness of the issue to reduce patient harm.

The agency advised that the devices be plugged into AC outlets whenever possible during patient use, as well as while the system is not in use. It added that users should be careful when transporting the device, and that operators should check battery run time and replace batteries as required.

The FDA suggested that any users experiencing issues should reach out, and that devices with known defects or malfunctions should be returned to the manufacturer.

In June, the FDA labeled a select recall of Cardiosave hybrid intra-aortic balloon pumps over issues related to fluid seepage and corrosion as Class I.

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Impulse Dynamics wins FDA panel date for Optimizer PMA

Impulse Dynamics

Impulse Dynamics has set a date with the FDA’s Circulatory System Devices Panel, part of the agency’s Medical Device Advisory Committee, discussing the premarket application for the company’s Optimizer Smart impulse generator device.

The Optimizer impulse generator is designed to remodel the myocardium to increase the heart’s efficiency using what the company calls the cardiac contractility modulation – non-excitatory electrical pulses delivered to the heart muscle. The system has had CE Mark approval in the European Union for the device since 2002.

The Stuttgart, Germany-based company will meet with the panel on December 4 and 5.

The panel will be seeking input “regarding the potential indications and labeling for devices intended to treat hypertension and optimal study designs needed to evaluate the potential benefits and risks while considering issues such as medication compliance, patient perspective, and appropriate study controls,” according to an FDA posting.

Last May, Impulse Dynamics said today that it closed a $45 million equity financing round to support its cardiac contractility modulation technology designed to treat chronic heart failure.

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The top 10 medical disruptors of 2019


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The Cleveland Clinic for the past 16 years has predicted what the top 10 medical disruptors will be for the following year.

The health provider seeks input from 150 to 200 of its physicians, hailing from each of its institutes. The result is 300 to 400 suggestions, which the clinic then narrows down to 150.

After that, 20 physicians meet and vote the list down to the top 10. The criteria to be considered a disruptor is that it has to be so innovative that it could change healthcare in a significant way in the next year.

The Cleveland Clinic announced this year’s top 10 list at its Cleveland Clinic Medical Innovation Summit, which took place Oct. 22-24 in Cleveland. From RNA-based therapies to alternative pain therapy to fight the opioid crisis, here are the Cleveland Clinic’s predictions of medical technologies that will prove disruptive in 2019.

Next >>

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