I come to this perspective from really an article by Jerome Grootman in the New Yorker, that then led me to a book, which I would argue everybody who's doing innovation in this space ought to read. And that is a expose as far as the abject failure, as far as how really the FDA and the government are monitoring the introduction of medical devices
I come to this perspective from really an article by Jerome Grootman in the New Yorker, that then led me to a book, which I would argue everybody who's doing innovation in this space ought to read. And that is a expose as far as the abject failure, as far as how really the FDA and the government are monitoring the introduction of medical devices
I remember when Ravage was introduced, and then we were doing it in you know, adolescence, and then we went into smaller children. And then we find ourselves in with acquired thoracic, you know, dystrophy, and asphyxia
I remember when Ravage was introduced, and then we were doing it in you know, adolescence, and then we went into smaller children. And then we find ourselves in with acquired thoracic, you know, dystrophy, and asphyxia
Pectus - Preoperative Assessment - Radiology and Cardiac Evaluation
▶Ep 4 · 2:48
clinicalThe Cincinnati Children's approach is selective in identifying patients who will benefit from surgery and emphasizes helping patients and parents deal with pain and discomfort, minimizing workup risks (ionizing radiation), and mitigating chronic pain and substance abuse risk.↗
▶Ep 4 · 2:48
clinicalPectus excavatum repair is arguably the most painful operation that could be done in a child.↗
▶Ep 4 · 2:48
quotearguably what is the most painful operation that could be done in a child↗
▶Ep 4 · 31:08
guidelineInsurance companies require some metric (abnormal pectus index plus evidence of cardiac dysfunction or abnormality) to approve coverage; providing multiple indices (Haller, correction, depression) plus cardiac dysfunction evidence has been effective in reversing denials.↗
▶Ep 4 · 42:03
host_summaryDr. Park in Korea, who performs the largest number of pectus repairs worldwide, argues that age 3 and older is safe for repair, and earlier is better.↗
▶Ep 4 · 42:31
clinicalWhen operating on younger patients, bars need to be shorter (not extending to mid-axillary line) to avoid impeding chest wall growth.↗
▶Ep 4 · 43:01
host_summaryOvercorrection from excavatum to carinatum can occur if repair is done too early, particularly in patients with connective tissue disorders (reported by Hopkins group).↗
▶Ep 4 · 43:35
host_summaryDr. Park reports seeing fewer asymmetric pectus patients because he corrects them when they're younger, suggesting early correction may prevent asymmetry development.↗
Pectus - Preoperative Assessment - Radiology and Cardiac Evaluation
▶Ep 8 · 2:48
clinicalPectus excavatum repair is arguably the most painful operation that could be done in a child.↗
▶Ep 8 · 2:48
clinicalThe Cincinnati Children's approach is selective in identifying patients who will benefit from surgery and emphasizes helping patients and parents deal with pain and discomfort, minimizing workup risks (ionizing radiation), and mitigating chronic pain and substance abuse risk.↗
▶Ep 8 · 2:48
clinicalThe Cincinnati Children's approach is selective in identifying patients who will benefit from surgery and emphasizes helping patients and parents deal with pain and discomfort, minimizing workup risks (ionizing radiation), and mitigating chronic pain and substance abuse risk.↗
▶Ep 8 · 2:48
clinicalPectus excavatum repair is arguably the most painful operation that could be done in a child.↗
▶Ep 8 · 2:48
quotearguably what is the most painful operation that could be done in a child↗
▶Ep 8 · 2:48
quotearguably what is the most painful operation that could be done in a child↗
▶Ep 8 · 31:08
guidelineInsurance companies require some metric (abnormal pectus index plus evidence of cardiac dysfunction or abnormality) to approve coverage; providing multiple indices (Haller, correction, depression) plus cardiac dysfunction evidence has been effective in reversing denials.↗
▶Ep 8 · 31:08
guidelineInsurance companies require some metric (abnormal pectus index plus evidence of cardiac dysfunction or abnormality) to approve coverage; providing multiple indices (Haller, correction, depression) plus cardiac dysfunction evidence has been effective in reversing denials.↗
▶Ep 8 · 42:03
opinionDr. Park in Korea, who performs the largest number of pectus repairs worldwide, argues that age 3 and older is safe for repair, and earlier is better.↗
▶Ep 8 · 42:03
host_summaryDr. Park in Korea, who performs the largest number of pectus repairs worldwide, argues that age 3 and older is safe for repair, and earlier is better.↗
▶Ep 8 · 42:31
clinicalWhen operating on younger patients, bars need to be shorter (not extending to mid-axillary line) to avoid impeding chest wall growth.↗
▶Ep 8 · 42:31
clinicalWhen operating on younger patients, bars need to be shorter (not extending to mid-axillary line) to avoid impeding chest wall growth.↗
▶Ep 8 · 43:01
host_summaryOvercorrection from excavatum to carinatum can occur if repair is done too early, particularly in patients with connective tissue disorders (reported by Hopkins group).↗
▶Ep 8 · 43:01
clinicalOvercorrection from excavatum to carinatum can occur if repair is done too early, particularly in patients with connective tissue disorders (reported by Hopkins group).↗
▶Ep 8 · 43:35
opinionDr. Park reports seeing fewer asymmetric pectus patients because he corrects them when they're younger, suggesting early correction may prevent asymmetry development.↗
▶Ep 8 · 43:35
host_summaryDr. Park reports seeing fewer asymmetric pectus patients because he corrects them when they're younger, suggesting early correction may prevent asymmetry development.↗
Update Course Rewind 2021 - Updates in Pectus
▶Ep 23 · 10:00
quoteI come to this perspective from really an article by Jerome Grootman in the New Yorker, that then led me to a book, which I would argue everybody who's doing innovation in this space ought to read. And that is a expose as far as the abject failure, as far as how really the FDA and the government are monitoring the introduction of medical devices↗
▶Ep 23 · 10:40
guidelineMedical devices and implants are not required to undergo clinical trials before market introduction, unlike drugs.↗
▶Ep 23 · 11:20
quoteI remember when Ravage was introduced, and then we were doing it in you know, adolescence, and then we went into smaller children. And then we find ourselves in with acquired thoracic, you know, dystrophy, and asphyxia↗
▶Ep 23 · 13:00
quotethere are also cases in social media who are talking about the fact that they're on gabapentin. And when is this terrible nerve pain going to disappear?↗
▶Ep 23 · 14:10
guidelineCryotherapy devices received FDA approval via 510(k) predicate pathway based on similarity to devices from 1976, not based on clinical trials.↗
▶Ep 23 · 17:00
quoteI challenge anybody on this panel to tell me that they're not long term consequences. And what are we going to do about that?↗
▶Ep 23 · 28:20
clinicalWith erector spinae catheters, hospital stay is two days with reduced opioid requirements both in-hospital and post-discharge.↗
APSA - Is same day discharge possible following the Nuss repair for pectus excavatum - R. Luke Rettig
▶Ep 24 · 4:37
quoteI wanna begin with the question, uh, just because it can be done, uh, should it be done?↗
▶Ep 24 · 4:37
quoteI wanna begin with the question, uh, just because it can be done, uh, should it be done?↗
▶Ep 24 · 4:42
quoteI personally don't feel that cryoablation is ready for prime time.↗
▶Ep 24 · 4:42
quoteI personally don't feel that cryoablation is ready for prime time.↗
▶Ep 24 · 4:48
quoteWe really don't know what the long-term consequences of this.↗
▶Ep 24 · 4:48
quoteWe really don't know what the long-term consequences of this.↗
▶Ep 24 · 4:53
opinionMedical devices typically are not subjected to the same rigorous, robust trials that drugs are↗
▶Ep 24 · 4:53
opinionMedical devices typically are not subjected to the same rigorous, robust trials that drugs are↗
▶Ep 24 · 5:24
opinionMany adverse consequences for medical devices are either underreported or not reported, as suggested by Kaiser Health News↗
▶Ep 24 · 5:24
opinionMany adverse consequences for medical devices are either underreported or not reported, as suggested by Kaiser Health News↗
▶Ep 24 · 5:41
opinionThe long-term consequences of cryoablation are unknown, particularly for children↗
▶Ep 24 · 5:41
opinionThe long-term consequences of cryoablation are unknown, particularly for children↗
▶Ep 24 · 5:52
opinionThere is concern about chronic neuropathic pain as a potential consequence of cryoablation↗
▶Ep 24 · 5:52
opinionThere is concern about chronic neuropathic pain as a potential consequence of cryoablation↗
▶Ep 24 · 6:24
quoteI'm arguing for a trial, randomized controlled trial, as well as a registry so that we can track right Doctor Red results.↗
▶Ep 24 · 6:24
quoteI'm arguing for a trial, randomized controlled trial, as well as a registry so that we can track right Doctor Red results.↗
Update Course Rewind: Pectus Excavatum 2021
▶Ep 25 · 3:01
opinionDr. Garcia's concern about cryoanalgesia is the absence of long-term studies and unknown potential for future adverse effects such as chronic neuropathic pain.↗
▶Ep 25 · 3:01
opinionDr. Garcia's concern about cryoanalgesia is the absence of long-term studies and unknown potential for future adverse effects such as chronic neuropathic pain.↗
▶Ep 25 · 3:01
quoteI agree with Sean. It works. I mean, it is great, one day. Yeah, no. So, um, what I'm concerned about is, is that there are no long-term studies.↗
▶Ep 25 · 3:01
quoteI agree with Sean. It works. I mean, it is great, one day. Yeah, no. So, um, what I'm concerned about is, is that there are no long-term studies.↗
▶Ep 25 · 3:09
quoteBut I believe we just don't know. We don't have the long-term data.↗
▶Ep 25 · 3:09
quoteBut I believe we just don't know. We don't have the long-term data.↗
▶Ep 25 · 3:24
quoteYou know, unlike drugs, medical devices and implants are not, are not required to undergo clinical trials before they're introduced into the market.↗
▶Ep 25 · 3:24
quoteYou know, unlike drugs, medical devices and implants are not, are not required to undergo clinical trials before they're introduced into the market.↗
▶Ep 25 · 3:24
guidelineUnlike drugs, medical devices and implants are not required to undergo clinical trials before being introduced to the market by the FDA.↗
▶Ep 25 · 3:24
guidelineUnlike drugs, medical devices and implants are not required to undergo clinical trials before being introduced to the market by the FDA.↗
▶Ep 25 · 3:55
clinicalDr. Garcia's institution studied approximately 100 patients comparing epidurals to erector spinal catheters for pectus excavatum pain management.↗
▶Ep 25 · 3:55
clinicalDr. Garcia's institution studied approximately 100 patients comparing epidurals to erector spinal catheters for pectus excavatum pain management.↗
▶Ep 25 · 4:08
clinicalErector spinal catheters are placed by the pain team with ultrasound guidance and are positioned juxtaposed to but not in the vertebral space.↗
▶Ep 25 · 4:08
clinicalErector spinal catheters are placed by the pain team with ultrasound guidance and are positioned juxtaposed to but not in the vertebral space.↗
▶Ep 25 · 4:19
quoteThose catheters stay in for 5 days. The hospital stay is 2 days. 3rd day, while they're outside, the catheters are pulled out by the family.↗
▶Ep 25 · 4:19
clinicalWith erector spinal catheters, the catheters stay in for 5 days, hospital stay is 2 days, and on the 3rd day while patients are at home, the catheters are pulled out by the family.↗
▶Ep 25 · 4:19
clinicalWith erector spinal catheters, the catheters stay in for 5 days, hospital stay is 2 days, and on the 3rd day while patients are at home, the catheters are pulled out by the family.↗
▶Ep 25 · 4:19
quoteThose catheters stay in for 5 days. The hospital stay is 2 days. 3rd day, while they're outside, the catheters are pulled out by the family.↗
▶Ep 25 · 4:31
clinicalDr. Garcia's institution achieved 2-day hospital stays with erector spinal catheters and reduced opioid requirements both in-hospital and at home.↗
▶Ep 25 · 4:31
clinicalDr. Garcia's institution achieved 2-day hospital stays with erector spinal catheters and reduced opioid requirements both in-hospital and at home.↗
▶Ep 25 · 4:45
clinicalErector spinal catheters achieve shorter stays than the 4-5 days seen with epidurals, though not the one-day stays achieved with cryoanalgesia.↗
▶Ep 25 · 4:45
clinicalErector spinal catheters achieve shorter stays than the 4-5 days seen with epidurals, though not the one-day stays achieved with cryoanalgesia.↗
▶Ep 25 · 8:08
host_summaryDr. Wolon uses a sternal elevator for pectus excavatum repair at Akron Children's Hospital.↗
▶Ep 25 · 8:08
clinicalDr. Wolon uses a sternal elevator for pectus excavatum repair at Akron Children's Hospital.↗
▶Ep 25 · 8:35
quoteSteve, we use the um elevator in every case, uh, but it offers, uh, there's no guesswork.↗
▶Ep 25 · 8:35
clinicalDr. Garcia uses the sternal elevator in every case because it eliminates guesswork and allows entry and exit at the same interspace.↗
▶Ep 25 · 8:35
clinicalDr. Garcia uses the sternal elevator in every case because it eliminates guesswork and allows entry and exit at the same interspace.↗
▶Ep 25 · 8:35
quoteSteve, we use the um elevator in every case, uh, but it offers, uh, there's no guesswork.↗
Update Course Rewind: Pectus Excavatum 2021
▶Ep 26 · 3:01
quoteI agree with Sean. It works. I mean, it is great, one day.↗
▶Ep 26 · 3:01
quoteI agree with Sean. It works. I mean, it is great, one day.↗
▶Ep 26 · 3:04
clinicalThere are no long-term studies on cryoanalgesia outcomes.↗
▶Ep 26 · 3:04
clinicalThere are no long-term studies on cryoanalgesia outcomes.↗
▶Ep 26 · 3:04
quoteWhat I'm concerned about is, is that there are no long-term studies.↗
▶Ep 26 · 3:04
quoteWhat I'm concerned about is, is that there are no long-term studies.↗
quoteUnlike drugs, medical devices and implants are not, are not required to undergo clinical trials before they're introduced into the market.↗
▶Ep 26 · 3:24
guidelineMedical devices and implants are not required to undergo clinical trials before being introduced to market, unlike drugs.↗
▶Ep 26 · 3:24
guidelineMedical devices and implants are not required to undergo clinical trials before being introduced to market, unlike drugs.↗
▶Ep 26 · 3:24
quoteUnlike drugs, medical devices and implants are not, are not required to undergo clinical trials before they're introduced into the market.↗
▶Ep 26 · 4:09
clinicalErector spinal catheters are placed by the pain team with ultrasound guidance, positioned juxtaposed to but not in the vertebral space.↗
▶Ep 26 · 4:09
clinicalErector spinal catheters are placed by the pain team with ultrasound guidance, positioned juxtaposed to but not in the vertebral space.↗
▶Ep 26 · 4:19
quoteThose catheters stay in for 5 days. The hospital stay is 2 days. 3rd day, while they're outside, the catheters are pulled out by the family.↗
▶Ep 26 · 4:19
clinicalWith erector spinal catheters, hospital stay is 2 days, catheters stay in for 5 days, and are pulled out by the family on day 3 while the patient is at home.↗
▶Ep 26 · 4:19
quoteThose catheters stay in for 5 days. The hospital stay is 2 days. 3rd day, while they're outside, the catheters are pulled out by the family.↗
▶Ep 26 · 4:19
clinicalWith erector spinal catheters, hospital stay is 2 days, catheters stay in for 5 days, and are pulled out by the family on day 3 while the patient is at home.↗
▶Ep 26 · 4:33
clinicalErector spinal catheters reduced opioid requirements both in the hospital and outside the hospital.↗
▶Ep 26 · 4:33
clinicalErector spinal catheters reduced opioid requirements both in the hospital and outside the hospital.↗
▶Ep 26 · 4:33
quoteWe've been able to reduce the opioid requirements, uh, not only in the hospital, but also outside of the hospital.↗
▶Ep 26 · 4:33
quoteWe've been able to reduce the opioid requirements, uh, not only in the hospital, but also outside of the hospital.↗
▶Ep 26 · 4:45
clinicalWith erector spinal catheters, hospital stays are 2 days, which is much less than the 4-5 days seen with epidurals.↗
▶Ep 26 · 4:45
clinicalWith erector spinal catheters, hospital stays are 2 days, which is much less than the 4-5 days seen with epidurals.↗
▶Ep 26 · 8:35
quoteSteve, we use the um elevator in every case, uh, but it offers, uh, there's no guesswork.↗
▶Ep 26 · 8:35
clinicalUsing a sternal elevator in every case eliminates guesswork and allows entry and exit at the same interspace.↗
▶Ep 26 · 8:35
quoteSteve, we use the um elevator in every case, uh, but it offers, uh, there's no guesswork.↗
▶Ep 26 · 8:35
clinicalUsing a sternal elevator in every case eliminates guesswork and allows entry and exit at the same interspace.↗
opinionDr. Garcia's concern about cryoanalgesia is the absence of long-term studies and unknown potential for future adverse effects such as chronic neuropathic pain.↗
▶Ep 1 · 3:01
quoteI agree with Sean. It works. I mean, it is great, one day. Yeah, no. So, um, what I'm concerned about is, is that there are no long-term studies.↗
▶Ep 1 · 3:09
quoteBut I believe we just don't know. We don't have the long-term data.↗
▶Ep 1 · 3:24
quoteYou know, unlike drugs, medical devices and implants are not, are not required to undergo clinical trials before they're introduced into the market.↗
▶Ep 1 · 3:24
guidelineUnlike drugs, medical devices and implants are not required to undergo clinical trials before being introduced to the market by the FDA.↗
▶Ep 1 · 3:55
clinicalDr. Garcia's institution studied approximately 100 patients comparing epidurals to erector spinal catheters for pectus excavatum pain management.↗
▶Ep 1 · 4:08
clinicalErector spinal catheters are placed by the pain team with ultrasound guidance and are positioned juxtaposed to but not in the vertebral space.↗
▶Ep 1 · 4:19
quoteThose catheters stay in for 5 days. The hospital stay is 2 days. 3rd day, while they're outside, the catheters are pulled out by the family.↗
▶Ep 1 · 4:19
clinicalWith erector spinal catheters, the catheters stay in for 5 days, hospital stay is 2 days, and on the 3rd day while patients are at home, the catheters are pulled out by the family.↗
▶Ep 1 · 4:31
clinicalDr. Garcia's institution achieved 2-day hospital stays with erector spinal catheters and reduced opioid requirements both in-hospital and at home.↗
▶Ep 1 · 4:45
clinicalErector spinal catheters achieve shorter stays than the 4-5 days seen with epidurals, though not the one-day stays achieved with cryoanalgesia.↗
▶Ep 1 · 8:08
host_summaryDr. Wolon uses a sternal elevator for pectus excavatum repair at Akron Children's Hospital.↗
▶Ep 1 · 8:35
clinicalDr. Garcia uses the sternal elevator in every case because it eliminates guesswork and allows entry and exit at the same interspace.↗
▶Ep 1 · 8:35
quoteSteve, we use the um elevator in every case, uh, but it offers, uh, there's no guesswork.↗
Update Course Rewind: Pectus Excavatum 2021
▶Ep 2 · 3:01
quoteI agree with Sean. It works. I mean, it is great, one day.↗
▶Ep 2 · 3:04
clinicalThere are no long-term studies on cryoanalgesia outcomes.↗
▶Ep 2 · 3:04
quoteWhat I'm concerned about is, is that there are no long-term studies.↗
quoteUnlike drugs, medical devices and implants are not, are not required to undergo clinical trials before they're introduced into the market.↗
▶Ep 2 · 3:24
guidelineMedical devices and implants are not required to undergo clinical trials before being introduced to market, unlike drugs.↗
▶Ep 2 · 4:09
clinicalErector spinal catheters are placed by the pain team with ultrasound guidance, positioned juxtaposed to but not in the vertebral space.↗
▶Ep 2 · 4:19
clinicalWith erector spinal catheters, hospital stay is 2 days, catheters stay in for 5 days, and are pulled out by the family on day 3 while the patient is at home.↗
▶Ep 2 · 4:19
quoteThose catheters stay in for 5 days. The hospital stay is 2 days. 3rd day, while they're outside, the catheters are pulled out by the family.↗
▶Ep 2 · 4:33
quoteWe've been able to reduce the opioid requirements, uh, not only in the hospital, but also outside of the hospital.↗
▶Ep 2 · 4:33
clinicalErector spinal catheters reduced opioid requirements both in the hospital and outside the hospital.↗
▶Ep 2 · 4:45
clinicalWith erector spinal catheters, hospital stays are 2 days, which is much less than the 4-5 days seen with epidurals.↗
▶Ep 2 · 8:35
clinicalUsing a sternal elevator in every case eliminates guesswork and allows entry and exit at the same interspace.↗
▶Ep 2 · 8:35
quoteSteve, we use the um elevator in every case, uh, but it offers, uh, there's no guesswork.↗
quoteI come to this perspective from really an article by Jerome Grootman in the New Yorker, that then led me to a book, which I would argue everybody who's doing innovation in this space ought to read. And that is a expose as far as the abject failure, as far as how really the FDA and the government are monitoring the introduction of medical devices↗
▶Ep 3 · 10:40
guidelineMedical devices and implants are not required to undergo clinical trials before market introduction, unlike drugs.↗
▶Ep 3 · 11:20
quoteI remember when Ravage was introduced, and then we were doing it in you know, adolescence, and then we went into smaller children. And then we find ourselves in with acquired thoracic, you know, dystrophy, and asphyxia↗
▶Ep 3 · 13:00
quotethere are also cases in social media who are talking about the fact that they're on gabapentin. And when is this terrible nerve pain going to disappear?↗
▶Ep 3 · 14:10
guidelineCryotherapy devices received FDA approval via 510(k) predicate pathway based on similarity to devices from 1976, not based on clinical trials.↗
▶Ep 3 · 17:00
quoteI challenge anybody on this panel to tell me that they're not long term consequences. And what are we going to do about that?↗
▶Ep 3 · 28:20
clinicalWith erector spinae catheters, hospital stay is two days with reduced opioid requirements both in-hospital and post-discharge.↗