everyone. margin XX.X%. of Thanks, Abiomed delivered third an operating XX% morning, the Todd. $XXX Good up quarter, In with million of year-over-year revenue,
revenue XX% we disclosed, in global by previously had As growth highlighted to a start quarter October. strong the
by Heart misleading American mid-November. Association, within in the However, negatively at presentations Heart the quarter, American the was two company Conference impacted
most I field next which designed Class we history our cardiogenic of outcomes PCI derived and experts becoming the strength and for recommendations new the of I the In company the confident XX for of with by recovery clinical steadfast wave protocols, start are and protocols, the circulatory heart the studies. the on guideline in care remains innovation, of Abiomed goal the clinical team. from and of practice studies Today, of of creating our now true standard announcing shock. feel about requires field, best of the years support high-risk clinical experience clinical with field
trials. also expertise We multiple clinical and infrastructure to execute have the
to high and Our the support. to customers attempt benefits risk again patients motivated of further clinical randomize and energized validate are Impella’s
for formula while outcomes. and Our patient innovate continue improve has been success training, time, data, and we to
today's on updates will will physician I current On data call, provide breakthrough expanding our and studies, highlight and education, clinical innovation. and I also
presentation called benefits. get enriched believes into the medical Before about initiatives, AHA Circulation. like its technology and in would debate the its be these clinical I clear, To journal free advanced comment by field published I of Abiomed and on is to merits the that
vigorously support fair this important We process. platforms for
did real-world The We research determined patients the of disclose and research." be Institutional to over researchers database other because analytical not "human of to building methods XX-year have in clinical evidence Board Review leader observational a Circulation and authors for our the study space misleading the for and is waived the subjects was not circulatory support. a because subset X% the publication this been manipulated
other regulatory the of all The and the at most escalated ECMO same totality data inaccuracies were the of excluded authors' paper lack Impella treatment hospitals. presentation other Both and utilized the which that of demonstrate publication patients both to Circulation contain NCDR who from the FDA and a knowledge IAB sickest the is the presentation, patients authors the factual nearly process. and therapies
and in what apply This authors data to the the was Circulation is frustrating that abstract and no request ultimately studies. currently with organization reputation research of another effectiveness requested authors and no other standards denied. scientifically Abiomed the this observational validate have the patient on on state in inotropes, data to and audit physician IABP, or directly independent care this paper the studies. virtually consistent ECMO third-party referrals, and and positive of Impella with most Impella validate the FDA journal, Based FDA impacting favor utilization,
response database PCI any papers patients XXXX majority billing up observational visibility on of has to Impella consistent database. to and better all elective has these vast patient cardiogenic studied outcomes third-party positive ranging to with billing since patients and have clinical adverse patients XX%. mortalities events and than and We collected negative high-risk the with of Abiomed shock mixing U.S. data
XX Over shortened published. clarify the and patient have FDA taken and the clinical is the evidence from medical vascular XXXX improved event The safety to community to learning data summary regulatory and we studies. concerns, stroke, on for our well and lowered physician-initiated this as real-world company and safety training, history has posted audited XXXX. misinformation technology years, major the respond the complications, as To and and of bleeding, have last outcomes, actions rates, educate education, curve, Abiomed's adverse the data to
high-risk review X,XXX registry initiated database. has patients has FDA and more with a Impella's and for leading of a of shock, has PCI, cardiogenic seven and series in IQ exclusive than right opinion tracked indications Abiomed practices in leaders than studies, CVAD calls physicians XX set on patients robust data five failure. support with studies, that clinical XXX,XXX Abiomed over post-market show heart the to has study produced best our more key embarked road multicity conference and our
Abiomed FDA hard our randomize pump endeavor. the is and as logistical are approval present they most ethical ninth are patients We've because we supported to physicians. challenges seven in effective. studied for $XXX the has this Abiomed and Impella in recognizes randomized safe controlled attempted invested trials, Impella of RCT. the million enrolling the and history over these with that exclusive heart or currently
key Now outcomes. high-risk turning best PCI to to back practices clinical is our Abiomed complement evidence to in cardiogenic optimize pursuing RCTs our and additional shock initiatives, and patient
as studies posted in a slides. a of We clinical data, the have successful shown series earnings for building formula through illustrated
RECOVER for high-risk for RECOVER RIGHT PROTECT shock, data PCI, feasibility our and and I pilot cardiogenic respectively. heart we shock First, safety right I, like and
along of RECOVER Next, studies FDA approvals RCTs RECOVER our PROTECT like RCT study. conducting RECOVER and FDA real-world RP RIGHT II like post-approval III, the practices, we high-risk Based conduct form collection guideline are which PCI II called Class with FDA data for indications recommendation. another best validation foundation our IV on support our data we our and and and clinical PROTECT help I and of III, a PROTECT to
revascularization. kidney released receiving meaning and with in undergoing patients yearly revascularization; procedures, which procedures two patients the The Impella XXX,XXX quality suffering to TCT, planned the risk with XXX,XXX at includes patients three exist to hemodynamic metrics readmitted patients versus will high-risk goal address hospital complete XXX,XXX PCI the from PCI trial XX is acute to compare today incomplete the with new procedures XX,XXX approximately designed days within trial PCI PCI. achieving staged that support of This injury challenges safely roughly of no support high revascularization,
Another every coronary improvement in today older not high-risk patients the preferably Complete disease with PCI or are offered over in be that failure advanced a setting the PCI. high-risk population exists XXX,XXX that ejection revascularizations, of surgery artery includes and kidneys goal should fraction single procedure. of heart protection
the for currently to PROTECT single includes is The into at eight development risk for being patient has study. EF high III XX and improvements The primary RESTORE for our arm arm EF days committee field steering one true the similar and months experts tested IV attract will MACCE PCI and been to both PROTECT hemodynamic the up year. the PCI support. and under Impella is endpoint in
clinical trials on Investor details our will and at more We provide our at in May. March in ACC Day
innovation clinical next and breakthrough by physicians treatment similar our steps will We take to data, to are help our and advance innovation. in confident adoption energized Impella that PCI other accelerate the
studies of in our the clinical on are DTU is update approved STEMI we RCT XX patients already with last the out XX that My FCA sites enrolling hospitals.
have we that XX announce enrolled date. to pleased are patients to We
are sites If recommendation of for with reperfusion care reperfusion to standard X this size is against Impella million worldwide. trial a successful, reduction. follow-up the it study Class and for this up attack patients combined open with allow unloading new heart guideline clinical I measure infarct For could population therapy designed patient a to randomizing
RECOVER and patients ready A therapies, at initiate practices support network treatment to at randomized XXXX. for STEMI on such when study will IV. study pilot The IABP AHA in Circulation successful cardiogenic details in investigators inotropes, future in of and sites, to of provided principal a be these and DTU other IV, priority STEMI ECMO. FDA The as more our XX will comparing RECOVER shock this published subset was Impella test is presented the best our currently but study
that which CAMP-PCI, effort with for training is the in investing Abiomed The is company's Myocardial skills optimize largest history. for program Protected outcomes. complete safer called this to This enhance launched PCI, improved PCI coordination best be utilizing practices education revascularization be Artery CAMP launch Coronary we later and month. as innovation procedures development for patient will of the enabled physician in educational and will to In mission stands PCI
create partnering on-site PCI password-protected that faculty for in to the online educational proctoring. include a We training and password-protected experts and community, programs, a programs support. in-house overall, field physician hemodynamic and user dedicated are include training, on physician education with will These national meeting will
discovered unable which and that Shaw, was and a fatigued at support heart heart Medical provide protected I left stents PCI. placed high-risk a to pump share began Dr. candidate an poor an was for St. job. Impella Fresno that issues from Michael XX-year-old heart example, on As would had Michael daily multiple feeling California Ali surgery determined severe a tasks. the causing function story was CP perform too of PCI. implanted EF Michael to for thorough Agnes and protected ideal Cardiologists with as like Center patient's he in experiencing XX%. blockages It an did to hemodynamic him
felt cars and three traveling Following working latest and than home. improvement Michael's back the ejection was on has is fraction was higher in to and he vintage normal family. Michael now nearly an he with He times procedure, discharged he better immediate years. feels and
easier patients get from and In profile the now with insertion heart ability also heart Impella wean-able X.X in very improve in only patients first required so XXX the flow, U.S. no publication designed launched SmartAssist the SmartAssist we for U.S. leading outcomes. on and which giving to the innovation, Turning fully XXX the feedback the rollout a positive sternotomy quarter continue been has pump is at a process. The heart their first to shown forward implant, cracking Impella we up to Impella in is been ambulate, Early CP smaller surgeons or has with which and chest our of open hospitals the making is with to and X.X axillary sites. the
reported increasing and function data adoption recent that criticism technology, some innovation. mortality, this population XX-year-old in believe segment. of failure Impella Like we A now high to especially publication epidemic risk the conclusion, revealed is In new growing with as JAMA a any that is challenges of the heart XX and to and clinical endure to is have all breakthrough we time. adapt
customer outcomes. every day. I every technology continued analyze and recognize to appropriately customers, utilize would welcome and for our like critique to patient and We who support shareholders put our their our improve our our thank and first help employees data to patients
remember time recognize forward called opportunity our percutaneous unloading will guidelines us the on We this I Class heart path to and pumps for for propel Impella.
over to Todd. turn now will the call I
