Explore the History of NPWT

The evolution of NPWT has occurred rapidly over the last 40 years. Understanding different eras of NPWT helps build a deeper appreciation of the therapy and its use today.

 

Early Principles of NPWT

1890 - 1990

Early NPWT was dominated by physician led experiments in the use of vacuum on open wounds and closed surgical incisions. Separate efforts within the US and in Russia were moving forward to share the discovery of NPWT for the benefit of patients without commercial interests.

Dr. Gustav Bier developed a cupping system with glass cups in a variety of shapes and sizes along with tubing and a bulb. This allowed for wound secretions to be extracted from various parts of the body.
Redon introduced and published his evacuated-bottle system of closed suction drainage in the management of surgical patients.
Medela enters medical vacuum space with its first breast pump, paving the way for medical suction.
On October 31, in Spartanburg, South Carolina, Mark Chariker, MD and Katherine Jeter successfully used negative pressure on their first patient, using a gauze based dressing and wall suction.

The same year in Kazan, Russia, Nail Bagautdinov, MD began using negative pressure with foam dressings to treat infected wounds with successful outcomes.
“The Kremlin Papers” are a compilation of five studies by Russian clinicians were published. They demonstrate ‘the effectiveness of NPWT in wound healing and reduction of hospital stay‘. As well, Nail Bagautdinov, MD published two influential papers describing the Bagautdinov method in Russian medical literature.
The Chariker-Jeter® Technique was first published in the article, “Effective management of incisional and cutaneous fistulae with closed suction wound drainage” in Contemporary Surgery.
Dr. Gustav Bier developed a cupping system with glass cups in a variety of shapes and sizes along with tubing and a bulb. This allowed for wound secretions to be extracted from various parts of the body.
Redon introduced and published his evacuated-bottle system of closed suction drainage in the management of surgical patients.
Medela enters medical vacuum space with its first breast pump, paving the way for medical suction.
On October 31, in Spartanburg, South Carolina, Mark Chariker, MD and Katherine Jeter successfully used negative pressure on their first patient, using a gauze based dressing and wall suction.

The same year in Kazan, Russia, Nail Bagautdinov, MD began using negative pressure with foam dressings to treat infected wounds with successful outcomes.
“The Kremlin Papers” are a compilation of five studies by Russian clinicians were published. They demonstrate ‘the effectiveness of NPWT in wound healing and reduction of hospital stay‘. As well, Nail Bagautdinov, MD published two influential papers describing the Bagautdinov method in Russian medical literature.
The Chariker-Jeter® Technique was first published in the article, “Effective management of incisional and cutaneous fistulae with closed suction wound drainage” in Contemporary Surgery.

Entry into US Market

1991 - 2000

An exciting time for NPWT, this decade was marked by patent filings, commercialization and the first attempt, via a patent infringement lawsuit, to restrict competition in the NPWT market.

Louis Argenta, MD and Michael Morykwas, file first US patents for the application of subatmospheric pressure on open wounds under Wake Forest University. Patents granted in 1997.
After rounds of negotiation with various medical device companies, Wake Forest agrees to license their newly filed patents to KCI.
Dr. Fleishmann, a doctor from Germany, was interested in wounds and introduced NPWT to Medela. Working together, they came up with preliminary designs for an NPWT system.
KCI commercialized the first device based upon the patents licensed from Wake Forest, Vacuum Assisted Closure (V.A.C.®).
Medela’s vacuum experts innovated the patented personal suction technology into the healthcare space.
KCI, in defense of the patents they’d licensed, filed a lawsuit against Medela and the marketing of Medela’s Vario suction pump in Germany for its use in wound healing.
Louis Argenta, MD and Michael Morykwas, file first US patents for the application of subatmospheric pressure on open wounds under Wake Forest University. Patents granted in 1997.
After rounds of negotiation with various medical device companies, Wake Forest agrees to license their newly filed patents to KCI.
Dr. Fleishmann, a doctor from Germany, was interested in wounds and introduced NPWT to Medela. Working together, they came up with preliminary designs for an NPWT system.
KCI commercialized the first device based upon the patents licensed from Wake Forest, Vacuum Assisted Closure (V.A.C.®).
Medela’s vacuum experts innovated the patented personal suction technology into the healthcare space.
KCI, in defense of the patents they’d licensed, filed a lawsuit against Medela and the marketing of Medela’s Vario suction pump in Germany for its use in wound healing.

Expansion in Market

2001 - 2010

Continuous efforts were made to restrict competition and innovation. However, BlueSky Medical, Medela and Smith & Nephew remained steadfast and were able to enter the NPWT market.

BlueSky Medical launches Versatile 1 for NPWT in the US market, sourcing the Medela Vario 18 as an OEM product. The Versatile 1 was sold with a gauze based dressing set following the 1989 Chariker-Jeter publications.
KCI files patent infringement suit against BlueSky Medical Group and Medela AG.
Understanding the importance to the industry and future innovation, Medela funded and managed the defense of BlueSky Medical against KCI.

Following three years of litigation Medela and BlueSky were found not-guilty of infringing KCI’s licensed patents.

BlueSky was granted the right to sell a competing product that used gauze instead of foam dressings.


With a ruling of non-infringement for Medela and BlueSky Medical, Smith & Nephew purchases BlueSky Medical, and in turn KCI files their first suit against Smith & Nephew.

After receiving FDA clearance in 2006, Medela launches Invia NPWT System with Vario. KCI subsequently files suit against Medela.
Medela launches Invia Liberty.
Smith & Nephew began selling foam based dressings for NPWT based on doctors’ preferences and Nail Bagautdinov research. KCI files suit against Smith & Nephew.
Judge Royal Furgeson ruled that the KCI patents were invalid, based on the concept of obviousness – meaning that a person with skill in this area could have taken the existing research and arrived at the V.A.C.®. Judge Furgeson stated in his ruling, “The Bagautdinov references, while they may not have been easily accessible to the inventors, disclose almost all the claims asserted."
BlueSky Medical launches Versatile 1 for NPWT in the US market, sourcing the Medela Vario 18 as an OEM product. The Versatile 1 was sold with a gauze based dressing set following the 1989 Chariker-Jeter publications.
KCI files patent infringement suit against BlueSky Medical Group and Medela AG.
Understanding the importance to the industry and future innovation, Medela funded and managed the defense of BlueSky Medical against KCI.

Following three years of litigation Medela and BlueSky were found not-guilty of infringing KCI’s licensed patents.

BlueSky was granted the right to sell a competing product that used gauze instead of foam dressings.


With a ruling of non-infringement for Medela and BlueSky Medical, Smith & Nephew purchases BlueSky Medical, and in turn KCI files their first suit against Smith & Nephew.

After receiving FDA clearance in 2006, Medela launches Invia NPWT System with Vario. KCI subsequently files suit against Medela.
Medela launches Invia Liberty.
Smith & Nephew began selling foam based dressings for NPWT based on doctors’ preferences and Nail Bagautdinov research. KCI files suit against Smith & Nephew.
Judge Royal Furgeson ruled that the KCI patents were invalid, based on the concept of obviousness – meaning that a person with skill in this area could have taken the existing research and arrived at the V.A.C.®. Judge Furgeson stated in his ruling, “The Bagautdinov references, while they may not have been easily accessible to the inventors, disclose almost all the claims asserted."

Medela Continues to Innovate

2011 - present

With the opening of the market from a reimbursement and legal perspective the first real competition entered the market. Manufacturers, like Medela, will able to continue innovation in the NPWT space.

Medela launches Molnlycke advance foam dressings for use with the Invia NPWT System.
Medela launches Invia Motion as the first of its kind, a personal NPWT pump.
Medela launched dressing kits with Invia FitPad and double lumen tubing.
With competitive pressures on products providing standard of care defined by the international consensus EWMA document, Medela now delivers a new business model to improve delivery of therapy.
Medela launches Molnlycke advance foam dressings for use with the Invia NPWT System.
Medela launches Invia Motion as the first of its kind, a personal NPWT pump.
Medela launched dressing kits with Invia FitPad and double lumen tubing.
With competitive pressures on products providing standard of care defined by the international consensus EWMA document, Medela now delivers a new business model to improve delivery of therapy.