1
`
` LIFECOR-1017
` ZOLL Lifecor Corporation v. Koninklijke Philips Electronics N.V.
` IPR2013-00606, IPR2013-00607, IPR2013-00609, IPR2013-00612,
`IPR2013-00613, IPR2013-00615, IPR2013-00616, IPR2013-00618
`
`

`
`Zoll Life-Vest data confirm its success.
`
`To date, 75,000 people have used the LifcVt-st that, on
`average, '5 saving, one life aclay. With 980 livessaved by
`Lifevest, the t,0ooth is expected soon.
`
`"Were getting ready for a big celebration," said Marshal
`Linclcr, Zoll LifeVest president and chiefoperating oflicer.
`
`_,
`PG graphic‘ Defebrillating vest
`{Click image mriarger version}
`
`fsD".u’E RTI EEM ENT
`
`When the heart's rhythm is so irregular the heart stops heating, :1 person must receive an
`electrical shock within five to 1 0 minutes to prevent death or brain damage. T hose whose
`experience one outside a hospital have less than a 1 O~pu1'c(:nl chance of good survival, with the
`rate generally related to how long it takes a paramedic or trained individual to arrive with a
`defibrillator and use it, said Norman C. Wang, the UPMC cardiac elcttrophysiologi-at who's treating
`Mr. NeiL‘;0n.
`
`Studies show that those who suffer a suddcn cardiac arrest in airports, casinos or other crowded
`
`venues that have readily available zrutornated external defibrillators have a survival rate of about
`50 11ercent_, Dr. Wang said.
`
`But Zoll cites a 98-percent "first-treatment shod: success rate" for resuscitating patients with the
`vest that doesn't require bystander intervention. When one is under way, the LifcVcst not only
`issues a shock but trarsrnits hem-t~rate details to the O'Hara facility that uses a secure online
`
`patient-mattagerncnt system to provide physicians with i.nformal:ion or alerts whenever
`arrhythmia or a cardiac arrest occurs.
`
`Cardiac arrest caused by arrhythmia involves a d.'s1-uptizin in the electrical impulses that cause the
`heart to beat. lt is different from a heart attack, which involves disrupted blood flow to the heart.
`
`One person wearing a Lifevcst, Mr. Linder said, collapsed from a cardiac arrest while at a walk
`but a timely treatment shock restored consciousness, allowing the person to walk home. Another
`person wearing a LifcVr£l awoke one morning to discover bedclothes covered with the blue gel
`that the vest released to increase (:t)1'1tiucti\-'ity for the electrical pads before the shed: occurs. The
`gel often serves as the only proof a patient hasthat he or she had received a life-saving shock.
`
`Invented in the 1986 by Stephen Heilman, the Life'\-’est developed throagh his company, Lifecor,
`received approval i.n 2001 from the US. Food and Drug Administration followed in 2005 by
`Medicare's approval for reimbursement. That led to soaring sales, Mr. Lindcr said. Zoll Medical
`purchased the company in 2e06, with Zoll Lifcvest experiencing revenue growth of 50 pl:1‘ct:nt a
`year with its O’!-Iara w(rkfo1'ce doubling over the past two years to more than 500 employees.
`The full rental price is $3,200 a month, which can be offset by insurance.
`
`jililtaburgl} 13031-éazettr’
`brought him back from the brink.
`
`On April 1.8, when Mr. Neilson began feeling il],l'1is wife took him to the Elk Regional Health
`Center in St. Marys, where he suffered a cardiac arrest, After his resuscitation, he was sent to
`UPMC Presbyterian on at medical lielioopter.
`
`A patient of Dr. Wang, Mr. Neilson was anideal Lzmdjdatte for an implantable carI:lim-'ertcr
`defibrillator, or ICD, that's surgically implanted in the chest to monitor heart rhythms and provide
`electrical shocks to ocrrect serious arrhythmia or counter a cardiac arrest.
`
`LE-ARM MORE
`
`2
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`

`
`But an active blood infection prevented Mr. Neilson from receiving an TCD at the time, So Dr.
`Wang prescribed a LifeVest, a temporary device that provides time todcterrninc whether a
`patient's condition can be treated better with rnedieations or heart surgery or allow a patient to
`overcome other medical problems that prevent the surgery to implant an 1CD, as 0u.'t11'1'(.'d with
`Mr. Neilson.
`
`Returning home, he wore the '£.ifeVest 24 hours a day for several weeks.
`
`On May 18, Mr. Neilson was resting in his recliner and watching the 5 pm, news when he fell
`unconscious seven minutes into the newscast. The electrne.-irdiograph the vest recorded tells the
`tale of what happened during the rninute~lcng cardiac arrest.
`
`Prirr to the attack, Mr. Neihorfs heart was beating normally for him, about once per second. But
`then the rhythms turned erratic, soon deteriorating into full-scale arrhythmia signifyirig, a cardiac
`arrest. For the next 14 seconds, the LifeVest monitored chaotic arrhythmia before initiating a
`"treatment sequence." Low- then high-level alerts were sounded, along with tactile alarms to
`provide a patient, if still oonscious, a chance to stop the painful electrical shock.
`
`But Mr. Ncilson was unoornscious, his eyes rolling back into his head.
`
`The device released the blue gel 35 seconds after the arrhythmia began. Chaotic rhythms began
`dropping in amplitude, indicating that the heart was quivering rather than heating and not
`pumping blood. In the fnlltrwing secmds his heart rate on the ECG had reduced to a wiggly line,
`alrnrst a flat line.
`
`Then it happened. Forty- five seconds into his rzurli-ac arrest, the LifeVest sent a 150*j0uleS shock.
`a pronounocd jolt, from the vest‘s front ponei through his heart to two receiving paneks on his
`b2lC.li.
`
`In another amazing sequence, the ECG showed that within two seco1rds,the shocl: reset Mr.
`Nci1<son's rnisfiring heartbeat, causing it return to a normal heartbeat, albeit one now beating twice
`rather than once a second. Save for a flutter or two, that trend continued until the Lifevcst sensed
`a restored heart rhythm. prompting it to discontinue the emergency sequence. One minute after
`the event began, the LifeVest had completed the treatment successfully and returned to
`monitoring the heart rhythms. It was ready to repeat the emergency sequence, if necessary.
`
`When Mr. Neiison awoke and recovered his senses, he heard his daughter Victoria calling 911. The
`blue gel smeared on his shirt made it clear to him he'd suffered a Cardiac arrest. Zoll soon alerted
`Dr. Wang with the details ofwhat had happened.
`An arnbulzince rushed Mr. Neilson to the Elk Regional Health Center and soon after he wa_<: down
`once again to UPMC, where this time he was able to have the ICD imphnted. He hasn't had a
`arrest Since May 18.
`
`"He al.T1’1ClSt certainly would have died at home" without the Litevest, Dr. Wang said
`
`Andtiiat's why Mr. Ncilson was sitting with a broad sniflc on a recent day inside the Zoll Lifevest
`building.
`
`"Ith the greatest invention I've ever come across, Eiving in rural Perms}'lvar1ia." he said. "1' his is
`modern technology. If someone wears one after this interview aiid it saves a life, it‘s worth it ."
`
`"lt dt-:finitcl3-' saved my life."
`
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