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SeaStar wins FDA breakthrough nod for selective cytopheretic device

The Selective Cytopheretic Device (SCD) [Image courtesy of SeaStar Medical]SeaStar Medical (Nasdaq:ICU) announced today that the FDA granted breakthrough device designation for its selective cytopheretic device (SCD).

Denver-based SeaStar designed the SCD for use in patients in the intensive care unit (ICU) with acute or chronic systolic heart failure. These patients have worsening renal function due to cardiorenal syndrome or right ventricular dysfunction. They’re awaiting the implantation of a left ventricular assist device (LVAD).

SeaStar’s SCD halts the downward spiral perpetuated by a hyperinflammatory state, SeaStar chief medical officer Dr. Kevin Chung says.

The company said it expects the breakthrough nod to expedite the clinical development and regulatory review of the SCD.

SeaStar submitted a first-in-human study that saw a patient with severe chronic heart failure treated with the SCD. That patient was ineligible for heart tran…

SeaStar Medical, Nuwellis partner on kidney injury treatment

SeaStar Medical’s Selective Cytopheretic Device (SCD) [Image courtesy of SeaStar Medical]SeaStar Medical (Nasdaq:ICU) and Nuwellis (Nasdaq:NUWE) today announced an exclusive U.S. license and distribution agreement.

Nuwellis agreed to market and distribute SeaStar’s selective cytopheretic device (SCD). The SCD treats acute kidney injury (AKI) in children. It selectively targets the most activated pro-inflammatory neutrophils and monocytes to stop cytokine storm. The system works with continuous kidney replacement therapy (CKRT) to help the body return to homeostasis.

“We share a commitment with SeaStar Medical to bring potentially lifesaving therapies to children undergoing CKRT therapy,” said Nestor Jaramillo, Jr., Nuwellis president and CEO. “To this end, we are also currently developing a new, fully integrated pediatric CKRT device designed to provide care for small babies and children under 20 kg., and we remain committed to developing and bringing to mar…

How SeaStar’s device calms hyperinflammation — and could prevent lasting damage from COVID cytokine storms

SeaStar Medical’s Selective Cytopheretic Device (SCD) [Image courtesy of SeaStar Medical]SeaStar Medical recently won FDA breakthrough device designation for a new way to treat hyperinflammation with technology that could help fight chronic conditions from COVID-19 infections.

The Denver-based medical developer is seeking a humanitarian device exemption for treating children with acute kidney injury (AKI) based on an FDA-funded study, SeaStar President and CEO Eric Schlorff said in an interview with Medical Design & Outsourcing.

The company is also planning a pivotal trial with around 200 adult AKI patients in early 2023, focused on reducing mortality and dialysis dependency.

SeaStar most recently studied the use of its Selective Cytopheretic Device (SCD) on 22 COVID-19 patients with multiple organ failure in ICUs. The treatment reduced mortality to 50% (compared to 81% in the control group), while patients who used the device for more than 96 hours saw…

How SeaStar’s device calms hyperinflammation — and could prevent lasting damage from COVID cytokine storms

SeaStar Medical’s Selective Cytopheretic Device (SCD) [Image courtesy of SeaStar Medical]

SeaStar Medical recently won FDA breakthrough device designation for a new way to treat hyperinflammation with technology that could help fight chronic conditions from COVID-19 infections.

The Denver-based medical developer is seeking a humanitarian device exemption for treating children with acute kidney injury (AKI) based on an FDA-funded study, SeaStar President and CEO Eric Schlorff said in an interview with Medical Design & Outsourcing.

The company is also planning a pivotal trial with around 200 adult AKI patients in early 2023, focused on reducing mortality and dialysis dependency.

SeaStar Medical CEO Eric Schlorff [Photo courtesy of SeaStar Medical]

SeaStar most recently studied the use of its Selective Cytopheretic Device (SCD) on 22…

Device developer SeaStar Medical hires chief medical officer

Dr. Kevin Chung will be the chief medical officer of SeaStar Medical. [Photo courtesy of SeaStar Medical]SeaStar Medical has hired Dr. Kevin Chung as chief medical officer of the medtech developer starting July 1.

Denver-based SeaStar is developing a platform therapy focused on hyperinflammation of vital organs. The company’s Selective Cytopheretic Device was designated as a breakthrough device by the FDA earlier this year.

SeaStar is set to go public in the third quarter of 2022 through a combination with special purpose acquisition company (SPAC) LMF Acquisition Opportunities (Nasdaq: LMAO).

Get the full story at our sister site, Medical Design & Outsourcing.

Device developer SeaStar Medical hires chief medical officer

Dr. Kevin Chung will be the chief medical officer of SeaStar Medical. [Photo courtesy of SeaStar Medical]

SeaStar Medical has hired Dr. Kevin Chung as chief medical officer of the medtech developer starting July 1.

Denver-based SeaStar is developing a platform therapy focused on hyperinflammation of vital organs. The company’s Selective Cytopheretic Device was designated as a breakthrough device by the FDA earlier this year.

SeaStar is set to go public in the third quarter of 2022 through a combination with special purpose acquisition company (SPAC) LMF Acquisition Opportunities (Nasdaq: LMAO).

“Dr. Chung’s decades of practical experience with known applications of extracorporeal therapies and his service as a critical care intensivist make him uniquely positioned to lead SeaStar Medical’s clinical development programs,” SeaStar President and CEO Eric Schlorff said in a news release. “We are…