FDA approves new Cardiovascular Systems saline pump after recall

Cardiovascular SystemsCardiovascular Systems (NSDQ:CSII) said yesterday that it plans to have a saline infusion pump on the market this summer to replace the pump it recalled last month, now that the FDA granted pre-market approval for the new pump.

The pumps are used to provide saline and lubricant during orbital atherectomies with CSI’s Diamondback 360 device. The St. Paul, Minn.-based company pulled roughly 900 of the pumps April 17 after finding that electromagnetic interference in hospitals can cause them to switch to standby mode. There were no reports of patient injury, CSI said, and customers can continue to use the older models until the newer versions are available.

“The company anticipates replacing all recalled units by no later than August 31, 2017,” CSI said.

The pumps were sold between April 7, 2015 and April 4 of this year. The recall is expected to deliver a $1.5 million charge during CSI’s fiscal 3rd quarter.

Yesterday the company met expectations on Wall Street with its 3rd quarter results, posting losses of $1.7 million, or 5¢ per share, on sales of $52.1 million. CEO Scott Ward said the recall is likely to be “moderately disruptive” during the fiscal 4th quarter, when the CSI expects to report net losses of -6¢ to -4¢ per share on sales of $51.5 million to $52.5 million.

AtriCure’s Q1 numbers top estimates

AtricureAtriCure (NSDQ:ATRC) beat the consensus forecast at both the top and bottom lines with its 1st-quarter results, sending share prices up 3% today.

Losses for the Mason, Ohio-based medical device company rose4.7% to -$10.2 million, or -32¢ per share, on sales growth of 14.8% for the 3 months ended March 31. Analysts on Wall Street were looking for losses of -35¢ on sales of $40.3 million.

The news sent ATRC shares up 3.0% to $21.30 apiece today in early trading.

“During the 1st quarter of 2017, we made significant progress across our strategic priorities, achieving solid results in our base open business while driving forward our transformation into the minimally invasive market,” president & CEO Mike Carrel said in prepared remarks. “We are advancing our clinical trials meaningfully with several new sites enrolling for Converge and expect enrollment to accelerate in the 2nd half of the year. We are looking forward to continued momentum across our business throughout 2017.”

AtriCure said it still expects to post losses of -94¢ to $1.04 per share this year, on constant-currency sales of $175 million to $178 million.

FDA labels Medtronic HVAD splice kit recall as Class 1

Medtronic Heartware

The FDA today labeled a select recall of Medtronic (NYSE:MDT) HeartWare Splice Kits designed to repair the driveline of its Ventricular Assist Device over electrical and pump stop issues as Class I.

Class I recall designations, the agency’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.

The splice kit is intended to repair the HVAD driveline, which connects the heart pump to an external controller which regulates the speed and function, if there is an electrical break, according to the FDA release.

The recall is over a design problem which could prevent the repaired cable assembly from withstanding excessive force or pulls and could cause damage to the cable assembly and interrupt electrical connections, the federal watchdog said.

Interruption in electrical connection may cause the pump to stop, which could lead to serious adverse health consequences including death, according to the FDA release.

The recall affects approximately 9 units in the US with product codes ASY00116 and ASY00281 distributed between Jan. 11, 2011 and May 23, 2014, according to the release.

Medtronic began contacting customers on March 16 about the issues, instructing health care specialists to investigate the appropriateness of driveline splice procedures given the new data.

FDA: Philips HeartStart MRx recall is Class I

Philips

The FDA today classified a Royal Philips (NYSE:PHG) recall of its HeartStart MRx monitor/defibrillator over electrical issues as Class I.

A Class 1 indication from the federal watchdog indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency.

The HeartStart MRx monitor/defibrillator is designed to deliver lifesaving electrical shocks to people with sudden cardiac arrest or to pace individuals with a slow heart beat, according to the FDA.

Electrodes on the unit are attached to the patient and then connected to the device to help it analyze the patient’s heart rhythm and deliver electrical shots to restore a normal heart rhythm.

The company is recalling the units due to electrical and battery connection issues which could prevent the device from powering up, charging and delivering electrical shock therapy, and could stop corrective pacing. The FDA said that a delay in delivery such therapy could result in serious patient injury.

The recall affects approximately 47,362 units across the US with model numbers M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8 and M3536M9, manufactured between Feb. 11, 2004 and Nov. 4, 2016 and distributed between Feb. 12, 2004 and Nov. 4, 2016.

Philips began notifying customers of the issue in Feb., according to the FDA.

Heart Societies update guidelines to support cardiac monitors for syncope patients

Medtronic

Medtronic (NYSE:MDT) said today that new guidelines from the American College of Cardiology, the American Heart Association and the Heart Rhythm Society now recommend the use of cardiac monitors for patients with syncope.

The updated guidelines for patients with syncope, or unexplained fainting, was published online in the Journal of the American College of Cardiology, Circulation and HeartRhythm.

Medtronic said that the new guidelines support the use of its Seeq MCT system, a wireless continuous external heart monitor that can be worn up to 30 days, and its Reveal Linq ICM with TruRhythm detection, an implantable monitor placed just beneath the skin which allows for wireless monitoring for up to 3 years.

“The causes of syncope can be difficult to diagnose as episodes are usually infrequent and unpredictable. Detection with short-term monitoring techniques is often unsuccessful and, as a result, patients may see several different specialists and undergo multiple tests without receiving a conclusive diagnosis. When the cause of syncope is unclear, continuous long-term cardiac monitoring has become the standard of care, particularly in early stages of evaluation,” Dr. David Benditt of the University of Minnesota’s Cardiac Arrhythmia Center said in a prepared statement.

The new guidelines recommend both external and implantable cardiac monitors based on the frequency of symptoms, with implantable cardiac monitors receiving a stronger recommendation based on evidence from randomized controlled trials of such devices, Medtronic said.

“Medtronic is committed to bringing meaningful innovations that help patients lead healthier lives, while providing clinicians with the best tools so that they can efficiently and effectively diagnose and treat their patients,” Medtronic patient monitoring & diagnostics VP & GM Nina Goodheart said in a press release.

The company won FDA approval for a next-gen Reveal Linq insertable cardiac monitor with TruRhythm Detection last week.

The Linq ICM with TruRhythm Detection offers exclusive algorithms which the company said resulted in a 95% reduction in false bradycardia episodes and a 47% reduction in false pause episodes compared with the previous-gen version of the device.

Last September, Medtronic launched the Linq device in Japan after winning approval from the Ministry of Health, Labor & Welfare.

FDA green-lights Aegis Medical trial for Sierra ligation device

Aegis Medical Innovation

Aegis Medical Innovations said today it won FDA investigational device exemption approval to begin a clinical trial of its Sierra Ligation System designed for left atrial appendage closure.

In the trial, Vancouver-based Aegis Medical aims to explore the safety and procedural success of the minimally invasive Sierra procedure in closing off the left atrial appendage in patients with atrial fibrillation.

“This study will confirm the safety of the Sierra device for patient use, and will lay a solid foundation for future efforts to demonstrate that Sierra can prevent stroke in AF patients and eliminate the need to take blood thinners for stroke prevention,” principal investigator Dr. Sheldon Singh of Toronto’s Sunnybrook Health Sciences Centre said in a prepared release.

“For many AF patients, anticoagulants are used to reduce the risk of stroke. One of the downsides of these drugs is that they can result in life-threatening bleeding. Aegis has developed a minimally invasive, non-vascular LAA closure device, that is designed to protect the patient from AF-related stroke without taking blood thinners. In contrast to vascular treatments, this non-vascular approach does not implant a device inside the heart that might migrate or cause clots in the LAA, thus potentially improving patient safety,” Dr. Vivek Reddy of Mount Sinai said in a press release.

The Sierra procedure involves closing off the LAA by placing a ligature around the base of the LAA and clinching it down with a lock. LAA closure procedures look to prevent clots from leaving the closed off LAA and eliminate them as a potential source for future stroke.

“Patients with AF are 5 times more likely to have a stroke, often due to clots that form in the left atrial appendage. We feel confident that the upcoming trial will show the Sierra procedure to be safe and effective for closing the LAA in patients suffering from AF,” Aegis prez & founder Trevor McCaw said in a prepared statement.

Medtronic wins FDA nod for CoreValve Evolut Pro

Medtronic Corevalve

Medtronic (NYSE:MDT) said today it won FDA approval for its CoreValve Evolut Pro transcatheter arortic heart valve replacement designed for treating severe aortic stensosis.

The newly cleared, next-gen CoreValve Evolut Pro features an outer wrap to add surface area contact between the valve and the native aortic annulus to increase valve sealing performance, Fridley, Minn.-based Medtronic said.

“Medtronic remains committed to working with interventional cardiologists and cardiac surgeons to deliver solutions that address patient needs with the safety and performance profile they expect from Medtronic. We are excited to introduce the next evolution of our Evolut TAVR platform to provide physicians with a comprehensive portfolio to address their patients’ needs,” Medtronic heart valve therapies biz VP & GM Rhonda Robb said in a prepared release.

The clearance came backed by data from a clinical study of the Evolut Pro, which met its primary endpoint at 30 days and reported a 98.3% rate of survival and a 1.7% rate of disabling stroke, Medtronic said.

A total of 72.4% of patients in the trial experienced trace amounts of paravalvular leakage or none at all, with no incidents of moderate or severe PVL reported at 30 days.

“The 30-day clinical outcomes presented at ACC demonstrate the Evolut PRO valve to be an outstanding treatment option for patients with severe aortic stenosis who are at a high or extreme risk for surgery,” Dr. John Forrest of the Yale University School of Medicine said in a press release.

The Evolut Pro system is designed to be delivered through the EnVeo R delivery catheter system and is indicated for vessels as small as 5.5mm, Medtronic said. The CoreValve Evolut Pro is available in the US in 23mm, 26mm and 29mm sizes, the company said.

“Based on my experience implanting the Evolut PRO valve during the clinical study, I’ve been impressed by the clinical outcomes achieved in our patients This innovation represents an important advantage over previous generations of this device, as it can help assist with adequate sealing even in complex cases,” Dr. Mathew Williams of the NYU Langone Medical Center said in a prepared statement.

Last December, Medtronic said it won reimbursement and Shonin approval from the Japanese Ministry of Health, Labor & Welfare (MHLW) for its CoreValve Evolut R transcatheter aortic valve replacement.