FDA warns that interim data from post-market Abiomed Impella RP study shows 17% survival rate

Abiomed's Impella RP

The FDA yesterday warned that interim data from a post-approval study of Abiomed‘s(NSDQ:ABMD) Impella RP heart pump system showed only a 17.4% survival rate, approximately 55% lower than the rate noted in the premarket study of the device.

The federal watchdog said that it is currently evaluating data from the study and that it will continue to monitor survival rates, but added that it still believes the system’s benefits outweigh the risks when used correctly.

In premarket clinical trials, results indicated a 73.3% survival rate to 30 days post device explant or hospital discharge, or to the start of the next longer term therapy, satisfying the study’s primary survival endpoint.

The post-market approval study of the device, which is slated to follow 60 patients through to one year, will have a similar primary endpoint of survival to 30 days post-explant, hospital discharge or the start of longer term therapy, the FDA said.

Interim results from the post-approval study, which currently has 23 patients, indicate a survival rate of only 17.4% of patients, or four of 23, have met the primary survival endpoint.

Upon analyzing the interim data, Abiomed said that the higher mortality rate may be primarily due to differences in pre-implant characteristics of patients, as 16 of the 23 patients in the post-approval study would “not have met the enrollment criteria for the premarket clinical studies,” according to the FDA release.

Patients in the post-approval study so far are more likely to have been in cardiogenic shock for longer than 48 hours, to have experienced an in-hospital cardiac arrest, have been treated with an intra-aortic balloon pump or suffered pre-implant hypoxic or ischemic neurological event when compared to patients in the premarket study, the FDA said.

“It is important to note that the Impella RP PAS and FDA’s evaluation into this issue are ongoing. We do not know the root cause for the high mortality rate, and the results are not adjusted for potential confounders,” the federal watchdog wrote in its posting.

The FDA warned healthcare providers to be aware of the differences in patient selection identified between the premarket and post-approval study cohorts when evaluating patient viability for therapy with the Impella RP.

Abiomed responded to the release by defending the Impella RP as the only device with FDA premarket approval for right side heart support, and saying that “proper use and timely implantation of the Impella RP increases survival with the potential for recovery of the right ventricle.”

The Danvers, Mass.-based company said that it proactively sent the interim data to physicians who use the Impella RP, including information on proper inclusion and exclusion criteria for patient selection.

Abiomed won clearance for the Impella RP in September of 2017, making it the only such device cleared for right heart failure.

Much like the company’s flagship Impella heart pump, the Impella RP is threaded into the heart via the femoral artery in the thigh. But unlike previous Impella models, all designed for the heart’s left ventricle, the Impella RP is designed to access the heart’s right ventricle via the vena cava.

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Abiomed touts CE Mark for Impella Connect, posts Street-beating FY2019 Q3 earnings

Abiomed

Abiomed (NSDQ:ABMD) said today that it won CE Mark approval in the European Union for its Impella Connect cloud-based Impella heart pump console and released fiscal year 2019 third quarter earnings that topped expectations on Wall Street.

The Danvers, Mass.-based company said its Impella Connect is a cloud-based platform that allows physicians and hospital staff to view the Impella console remotely, as long as they have an internet connection.

“Impella Connect is an extremely valuable resource that allows me, as well as allied health professionals and nursing staff, to have direct visualization of data from the Impella console and to closely monitor patients on hemodynamic support, in real time,” Dr. Rajeev Narayan of the Vassar Brothers Medical Center said in a prepared statement.

The system has already won FDA premarket approval, and is in a limited market release in the US, Abiomed said, with 36 hospital sites already using the technology. The first European center slated to use the technology is Hamburg, Germany’s University Heart Center.

“Impella Connect is a technological advancement which represents the next frontier of heart recovery products. Impella Connect, along with our 24×7 onsite and on-call support, enables physicians, nurses and ICU staff to increase productivity, improve patient outcomes, and help patients return home with their native heart,” prez & CEO Michael Minogue said in prepared remarks.

In its earnings release, Abiomed posted profits of approximately $44.9 million, or 97¢ per share, on sales of approximately $200.6 million for the three months ended December 31, for massive bottom-line growth of 233.6% while sales grew 30.2% compared with the same period during the previous year.

Earnings per share were just ahead of the 94¢ consensus on Wall Street, where analysts expected to see sales of approximately $196 million, which the company also topped.

“We are proud of our 100,000th patient milestone and we will continue to grow the field of heart recovery and improve patient outcomes by partnering with our customers to use real-world data to identify and validate best practices and protocols. We remain focused on disciplined execution and sustainable growth so that even more patients around the world can benefit from heart recovery,” prez & CEO Michael Minogue said in a press release.

The company lifted its full fiscal year 2019 financial guidance, expecting to post sales of $780 million, up from previous guidance of between $765 million and $770 million.

Abiomed added that it also updated its GAAP operating margin expectations from between 28% and 30% to between 29% and 29.5%.

Shares in Abiomed have risen 6.4% so far today, at $361.35 as of 11:26 a.m. EST.

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Abiomed wants whistleblower to cough up employment records

AbiomedAbiomed (NSDQ:ABMD) yesterday asked a federal judge to force whistleblower Max Bennett to cough up his employment records with another company, countering his retaliatory termination claim by alleging that it fired him for lying about the circumstances of his departure from his last job.

Documents unsealed in March 2018 revealed that Max Bennett accused the Danvers, Mass.-based heart pump maker of firing him in retaliation for accusing it of a kickbacks scheme involving the wining and dining of physicians at fancy restaurants to encourage them to use its Impella pump, according to court documents. Abiomed agreed that month to pay $3.1 million to settle the whistleblower case with the U.S. Justice Dept.; Bennett was due $542,000 from the settlement, the Justice Dept. said at the time.

Now Abiomed alleges that Bennett lied about being fired from Biotronik and wants the court to force him to produce his employment records to prove it. Bennett declined to produce the documents during discovery, arguing that they are barred under a nondisclosure agreement and are irrelevant to boot, according to the documents.

“Abiomed’s primary defense to plaintiff’s claims is that plaintiff was terminated because of his dishonesty during the interview process about the circumstances of his separation from Biotronik, not because of any alleged complaints he made,” the company argued. “Abiomed also believes that any complaints that Plaintiff made after he was confronted regarding his apparent false representations regarding the circumstances of his separation from Biotronik were not made in good faith.” [emphasis theirs]

During the interview process ahead of his October 2012 hiring, Bennett told Abiomed that he left Biotronik after the cardiac rhythm management company changed its sales model.

“In 2010, I left Biotronik due to changes in the business model. Biotronik chose to pursue an independent model vs. a direct model, which in turn minimized the functional need for management positions. I signed a non-disclosure and took a severance option at that time. Given my entrepreneurial personality and strong network in the industry, I decided to try my own consulting,” Bennett wrote in an email filed with Abiomed’s motion to compel.

The requested documents are critical to its case, the company argued, “because they will show that plaintiff was, in fact, terminated from Biotronik, in direct contradiction to statements he made to Abiomed during the interview process that his separation from Biotronik was voluntary.

“Abiomed understands that plaintiff is concerned that production of the requested documents would breach a confidentiality provision set forth in an agreement he entered with Biotronik. However, counsel also understands that the Biotronik agreement provides that it will not be a violation of the confidentiality provision if production is made pursuant to a court order. Given this, any such concern will be resolved by an order of this court,” Abiomed argued in the Jan. 9 motion.

Earlier this week the company won another lawsuit brought by a former employee, who alleged unfair termination and the denial of an options deal tied to Japanese approval for Impella.

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Ex-Abiomed exec loses $2m lawsuit

Abiomed

A former Abiomed (NSDQ:ABMD) Asia VP lost a lawsuit that sought $2.1 million in damages, alleging unfair termination and the denial of an options deal tied to Japanese approval of its Impella heart pump.

The Danvers, Mass.-based heart pump maker hired the plaintiff, Keisuke Suzuki, in 2010 to help it pursue Japanese regulatory approval for the Impella device. Their agreement included a provision that would give Suzuki 45,000 ABMD shares pegged to Japanese regulatory milestones.

Suzuki claimed that Abiomed was resistant to his suggestions and recommendations for winning approval from the Japanese Ministry of Health, Labour & Welfare and Japan’s Pharmaceutical & Medical Device Agency, unnecessarily prolonging the process. Abiomed was on target to achieve approval of the devices in 2015, having met with Japan’s PMDA and established guidelines for what was necessary for the clearance, Suzuki alleged, according to court documents.

After the PMDA meetings, he claimed, the company began to give him false negative job performance reviews, sought to demote him and to “change the terms of his compensation so as to take away his stock rights and future commission rights,” according to the documents.

The lawsuit alleged that Abiomed fired him without the 28-day notice required by his contract and denied him the 20,000 ABMD shares he was allegedly due based on Japanese approval of the Impella line. Suzuki sought damages for the alleged retaliation, lost wages and the price of the shares.

Abiomed denied all of Suzuki’s claims and alleged instead that it took another 15 months after Suzuki’s firing to win Japanese approval for Impella. The company asked for summary judgment from Judge Denise Casper of the U.S. District Court for Massachusetts, who last week granted the motion.

“Given that Suzuki was not due compensation for a milestone that was not achieved at the time of his termination and was not achieved until 15 months later after considerable additional effort by Abiomed, such that it cannot be reasonably concluded that he was ‘on the brink’ of reaching this milestone, Abiomed’s termination of Suzuki does not amount to bad faith or violation of the implied covenant of good faith and fair dealing,” Casper ruled Jan.4, according to the documents.

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Abiomed jumps on fiscal Q3 prelims, raised outlook | Wall Street Beat

MassDevice.com Wall Street BeatAbiomed (NSDQ:ABMD) shares got a jump today from its preliminary fiscal third-quarter numbers and an improved outlook for the rest of its fiscal year.

The Danvers, Mass.-based heart pump maker said it expects to post fiscal Q3 sales of roughly $200.6 million, representing a 30.3% increase over its fiscal Q3 top line.

Abiomed also raised its revenues guidance for fiscal 2019, saying it now expects full-year sales of about $780 million, up from $765 million to $770 million previously.

The news sent ABMD shares, which closed up 3.7% at $313.44 apiece Jan. 4, up some 2.1% to $320 even today in pre-market trading.

The company said it plans to issue its full fiscal Q3 results Jan. 31.

NuVasive’s Q4, annual prelims deliver a blow

NuVasive Inc. (NSDQ:NUVA) said today that it expects to post fourth-quarter sales of approximately $288 million and full-year revenues of roughly $1.10 billion.

“In the fourth quarter and full year 2018, we continued to grow above market, driven by new product introductions and strong performances in key global geographies,” CEO Christopher Barry said in prepared remarks. “We are encouraged by our mid-single digit growth in a stable U.S. spine market, while experiencing some temporal surgeon case volume disruptions that impacted the fourth quarter results, along with a delay in timing of capital equipment orders.

“In 2018, NuVasive launched more than a dozen new technologies and initiated several strategic partnerships—all designed to support innovation and help deliver better, more predictable patient outcomes,” Barry added. “The company will continue to focus on delivering disruptive technology with a focus on the core hardware portfolio and navigation, imaging and robotics, while enhancing operational excellence and strategically investing in profitable growth areas in 2019.”

The San Diego-based spinal implant maker said it plans to issue its full quarterly and annual results, and its outlook for 2019, in late February.

NUVA shares took a hit early today, falling -4.1% to $48.03 apiece.

Cardiovascular Systems ticks up on fiscal Q2 prelims

Cardiovascular Systems (NSDQ:CSII) shares ticked up today after the St. Paul, Minn.-based company reported its preliminary fiscal second-quarter sales numbers.

CSI said it expects to log sales of $60.2 million when it reports its full fiscal Q2 result Jan. 30, when it also plans to update its guidfance.

“Our strategy to accelerate revenue growth remains firmly on track. During the first half of fiscal 2019, our domestic atherectomy franchises grew 11%, including $1.3 million of new revenue from the sale of OrbusNeich angioplasty balloons and Zilient guidewires. International revenue was approximately $3 million,” chairman, president & CEO Scott Ward said in prepared remarks. “Our revenue results year-to-date position CSI to deliver fiscal 2019 revenue in a range of $243 million to $247 million, an increase of 12% to 14% compared to fiscal 2018. We plan to provide formal guidance details when we report fiscal second-quarter results at the end of the month.”

Investors initially responded by sending CSII shares up 1.5% to $29.51 apiece today in early trading.

Wright Medical slips on Q4 prelims

Wright Medical (NSDQ:WMGI) share prices slipped this morning after the orthopedic extremities company released preliminary fourth-quarter and 2018 sales numbers that disappointed Wall Street.

Memphis-based Wright said it expects to post sales of $238.1 million for Q4 and $836.2 million for the full year.

“Our preliminary fourth-quarter results represent an outstanding performance across our businesses. This performance was driven by continued strong shoulder growth, including the ongoing launch of our Perform Reversed glenoid and continued contributions from our Simpliciti shoulder system. We anticipate that these products, as well as accelerating adoption of our Blueprint enabling technology and the upcoming launch of our Revive revision shoulder system, will continue to drive strong shoulder sales growth in 2019 and beyond,” president & CEO Robert Palmisano said in prepared remarks. “In our U.S. lower extremities business, we got off to a very strong start with Cartiva revenue of approximately $9.5 million, which exceeded our expectations in the fourth quarter. On Jan. 1, Cartiva was fully launched with our U.S. lower extremities sales force, including the integration of the former Cartiva distributors that we have chosen to retain. We also saw continued strong growth in our core products as well as in total ankle. We intend to continue to focus on strong execution and new product launches throughout 2019.”

Wright updated its longer-term financial goals, saying it should meet a prior target of 20% adjusted EBITDA margins for Q4 2019. For 2019 through 2021, the company said it expects double-digit, constant-currency sales growth, adjusted gross margins in the high 70% range and adjusted EBITDA margins in the mid-20% range by the end of 2021.

“Delivering on these long-term financial targets is expected to make Wright a company with a best in class combination of size, growth and adjusted EBITDA margin. I believe our leadership positions in high-growth markets, combined with specialized sales forces and differentiated technologies positions us well to achieve these targets and deliver enhanced shareholder value,” Palmisano added.

WMGI shares slid -1.2% to $27.44 each today in early-morning trading.

The company said it plans to report its full results and issue new guidance Feb. 26.

Full-year, Q4 prelims send CAS Medical Systems up a hair

The prelims sent share prices up a hair for CAS Medical Systems (NSDQ:CASM) today.

Branford, Conn.-based CasMed said it expects Q4 sales to reach $5.8 million and full-year sales to hit $21.9 million.

“I’m pleased to report record Fore-Sight oximetry sales for the fourth quarter, with strong growth coming from the U.S. and international markets and our fifth consecutive quarter of year-over-year double-digit Fore-Sight sales increases,” president & CEO Thomas Patton said in prepared remarks. “Fore-Sight disposable sensor sales for the quarter grew 20% and represented 90% of total sales. We attribute this growth primarily to strong execution by our maturing domestic salesforce and growth from key international distributors as we expand the market for our Fore-Sight products worldwide.”

CasMed plans to update its 2019 outlook mid-year, Patton added. Full Q4 and 2018 results are slated to be released in early March, the company said.

CASM shares were up 0.5% to $1.92 today in early trading.

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Abiomed puts $15m into Shockwave

Shockwave's S4 Lithotripsy CathAbiomed (NSDQ:ABMD) plans to invest $15 million in Shockwave Medical and collaborate on a training and education program in the U.S. and Germany, according to a newly-inked deal between the two companies.

Shockwave’s intravascular lithotripsy technology uses sonic pressure waves to crack vascular calcium in the vessel wall, allowing arteries to expand under low pressure. The company said its catheter is often used in patients with heavily calcified Iliac arteries in order to prepare for the delivery of devices with catheters, like transcatheter heart valves and Abiomed’s Impella heart pump.

“While we are still early in our commercial scaling both in the US and Europe, I am pleased with how positively our Shockwave technology has been received and how many different types of patients and vessels our customers are able to safely treat with our IVL system,” Shockwave’s president & CEO Doug Godshall said in prepared remarks.

“We are delighted to be able to offer patients our solution in combination with Abiomed’s Impella technology using a minimally invasive approach, which should meaningfully improve outcomes. With Abiomed’s best-in-class approach to training and education, Shockwave will be able to more efficiently increase awareness and introduce IVL to customers, which we believe will help them better treat their most challenging patients.  We are encouraged to see the positive clinical response we have witnessed to date,” Godshall added.

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10 of the best performing medical device stocks of 2018

(Image from Unsplash)

Nearly half of the world’s 100 largest medical device companies saw their stock prices increase by double-digit percentages during the first 10 months of 2018, according to a Medical Design & Outsourcing analysis.

The feat is even more amazing considering that October was a rocky month for the Dow Jones Industrial Average, with the year’s gains mostly erased amid worries over Federal Reserve interest rate hikes and the U.S.-China trade war.

Medical device companies were able to buck the trend thanks to a number of different factors, including strong product launches, positive clinical trial results, new markets opening up or internal changes.

Being innovative mattered, too. It’s not too surprising that some medical device companies spending a large amount on R&D compared to revenue – including Dexcom, Abiomed, Atricure, Edwards Lifesciences and Insulet – saw their stock prices skyrocket as they marketed innovative devices in fields including diabetes management and cardiology.

Here are 10 of 2018’s top performers and a bit about what each has accomplished so far this year.

Next>>

Managing editor Chris Newmarker contributed to this report. 

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Abiomed shares slide despite Impella CP trial success

Abiomed

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 MassDevice.com 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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Abiomed shreds fiscal Q2 forecasts

AbiomedAbiomed (NSDQ:ABMD) today 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.

The Danvers, Mass.-based cardiac assist device maker more than doubled its profits to $50.1 million, or $1.09 per share, on sales of $181.8 million, for a 104.6% bottom-line gain on revenue growth of 36.9%.

Analysts on Wall Street were looking for EPS of 74¢ on sales of $175.2 million.

“We have established a strong foundation with our innovation and technology, balance sheet and intellectual property portfolio,” chairman, president & CEO Michael Minogue said in prepared remarks. “We are executing our plan for sustainable growth while helping to improve patient outcomes focused on native heart recovery.”

Abiomed boosted the low end of its full-year revenue guidance for the second quarter in a row, saying it now expects to log revenues of $765 million to $770 million, compared with $755 million to $770 million previously. The company stood pat on its GAAP operating margin guidance of 28% to 30%.

ABMD shares were up 6.2% to $362.35 apiece today in early trading.

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